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Best Practices in Clinical Pharmacology Gap Analysis
 
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Submitting your New Drug Application (NDA) to the US Food and Drug Administration (FDA) is the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency will ask about your clinical pharmacology data package at the time of a NDA submission? If the thought gives you “pre-test jitters,” you might want to invest in a clinical pharmacology gap analysis—a tool that can help you evaluate and address any potential gaps in your program before the FDA does. The field of clinical pharmacology can help stakeholders address these challenges and improve decision-making at critical milestones, whether early in proof-of-concept phases (pre-clinical through 2a) or in the later stages where a more robust risk and efficacy profile is established (2b through 3). The tools, methods, and frameworks (eg, mechanistic or quantitative) of clinical pharmacology span distinct sub-specialties and can significantly impact these pre-clinical and clinical phases. Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA. By watching this webinar, you will learn the following: -What questions the agency will ask about your clinical pharmacology data package at the time of a NDA submission -How gap analysis can help you develop a clinical pharmacology development strategy that covers all relevant domains -What data to gather and when to gather it to enhance decision-making during development -How a clear clinical pharmacology plan can assist in negotiations with regulators and investors during IND development -What quantitative analyses (pharmacometrics and other model-informed drug development technologies) can be leveraged to diminish dedicated study needs and accelerate your path to drug approval
Просмотров: 328 Certara
Challenges of Implementing CDISC SDTM Standards for FDA Submissions | Medidata
 
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In this video, Miganush foresees upcoming challenges for pharmas around the conversion of existing legacy data to CDISC standards for submissions. Medidata's Patrick Chassaigne and PROMETRIKA's Miganush Stepanians discuss key industry trends around data management, at the recent Partnerships in Clinical Trials conference in Las Vegas. With the FDA now mandating CDISC SDTM standards, data should be submitted in CDISC format in order to be truly compliant. And although some companies are struggling with legacy data from paper-based or older systems that were not CDISC compatible, many tools are now being developed to tackle those challenges. Watch the clip for more from Patrick and Miganush. || What is Medidata? || Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. || Our Products || Our fully integrated software suite supports your full journey through the clinical research process from beginning to end. Explore all the products we have to offer: http://ow.ly/nEgv30cKFcf || More Medidata|| SUBSCRIBE: http://ow.ly/NkMq30cKFzj Visit our WEBSITE to learn more: http://ow.ly/vCiP30cKFsD Connect with us on LINKEDIN: http://ow.ly/xMx130cKF8E Like us on FACEBOOK: http://ow.ly/d1V830cKEYD Follow us on TWITTER: http://ow.ly/8gMl30cKF5Y Read our BLOG: http://ow.ly/Esvz30cKFaF Find your next CAREER: http://ow.ly/QJn730cKFhN || Questions?|| CONTACT our sales and support teams by email or phone: http://ow.ly/rsDT30cKFvY MESSAGE us directly: http://ow.ly/zSXh30cKFug
Просмотров: 1182 Medidata Solutions
ADaM Validation Update from OpenCDISC
 
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On March 24, 2015, CDISC published Version 1.3 of its ADaM Validation Rules. The release's main goal was to add new business rules for ADAE and BDS-TTE. In this webinar, we will provide an overview of recent changes and share our experience of the most common issues in ADaM submission data observed across the industry. Our speaker is Pinnacle 21’s own Michael DiGiantomasso. Mike serves on the CDISC’s ADaM Validation sub-team and is a Data Fitness Analyst on the FDA JumpStart project.
Просмотров: 2733 Pinnacle 21
Strategies for Analgesic Development and the New FDA Guidance for Analgesic Indications
 
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CDER recently issued an updated draft guidance for Analgesic Indications. In this webinar, Brett Gordon and Ben Vaughn provide a high-level review of the agency’s guidance, offer strategies for analgesic product development and share experiences with PROs and paper vs. tablet collection. Ben Vaughn, Senior Statistical Scientist at Rho, has twelve years of experience in clinical research. He has participated in nearly 20 regulatory submissions, coproduced the ISE for two opioid products; and provided statistical consultation, display generation and submission work for four separate products for OA knee pain. Last spring he attended an FDA advisory committee to represent the sponsor for an opioid product. He has authored responses to various FDA queries regarding NDAs, PMAs, IDEs, and SPAs. Additionally, he has represented sponsors in FDA teleconferences and face-to-face meetings for both OA knee pain products and opioid products. His analytic experience includes cross-over studies, survival analysis, non-parametrics, and extensive work with linear and non-linear repeated measure models. Brett Gordon, Project Director at Rho, has more than fifteen years of overall clinical development experience, including eleven years in project management, encompassing trials of varying sizes and complexity, both domestically and internationally. He has extensive knowledge of clinical development including initial development plan formulation, protocol writing, trial implementation, monitoring and delivery, clinical study report writing, and regulatory submission to support of marketing applications. Brett has worked across numerous therapeutic areas and in particular possesses in-depth CNS experience, including four years at an orthobiologics company supporting clinical development activities for ultrasound bone healing and two hyaluronate products for osteoarthritis.
Просмотров: 252 RhoInc1984
FDA Provides Guidance to Identify Gaps in Development Plan
 
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Promoting Successful Translational Research: http://launchpad.ucsf.edu. Drs. Michael Matthay and Kathleen Liu describe their experience in taking a novel stem cell therapy for acute lung injury into clinical trials. Their work, in collaboration with Drs. Jae Woo Lee and Carolyn Calfee, produced compelling efficacy and safety data. However, early interactions with the FDA and guidance from Catalyst Awards adviser, Dr. David Savello, provided valuable insights that guided their research approach which have resulted in the approval to initiate a Phase I clinical study. Learn more at http://launchpad.ucsf.edu
Просмотров: 985 ctsiatucsf
Writing and Maintaining EU Clinical Trial Authorization Trailer
 
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The Regulatory Affairs department must prepare documents that inform European Regulatory Agencies about the proposed development plan; submit a Clinical Trial Authorization (CTA) to initiate human clinical trials; answer questions about on-going investigations; and construct and submit any updates to the CTA in a concise and informative manner. Regulatory submissions are more than just writing – they encompass strategy, research, writing, organizing and leading a team, compiling, editing, publishing, and tracking of the information. When initiating a global clinical trial program, many moving parts need to be brought into harmony to ensure compliance and that timelines are met. Web seminar attendees will walk away with tools to help plan, write, and manage multiple CTAs with all their differing requirements.
Просмотров: 42 Kathy Barnett
Ready to Adopt the Regulatory CDISC Standards for Next Clinical Trial?
 
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Understanding the regulatory landscape and practical data preparation steps available to trial sponsors. Mark Vermette, The Halloran Group joins Cytel's Angelo Tinazzi (Certified CDISC Instructor) New regulatory expectations are taking shape, including the need for interactive and transparent clinical data handling, increased safety data demands and electronic data (CDISC) submission. Trial sponsors must carefully plan their data consolidation and analysis strategies not only in preparation for CDISC-compliant submissions, but to respond to market influences and evolving clinical partnership models.
Просмотров: 202 CytelVideos
Writing Clinical Study Protocols Trailer
 
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The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval. Over the course of a development plan, new protocols, amendments, and concept sheets will be needed. Protocols for Phases 1, 2, 3 and 4 require different writing approaches and you must know what the agency expects at every development milestone to avoid the trial being put on clinical hold. Moreover, amendments, however unwelcome, are a necessary part of the development process.
Просмотров: 350 Kathy Barnett
Immune Pharmaceuticals (IMNP) Receives FDA Guidance for Phase III Pivotal Trial
 
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SCN's Jane King sits down with Dr. Daniel Teper, CEO & Founder of Immune Pharmaceuticals Inc. (NASDAQ: IMNP ), and Chief Medical Officer Dr. Monica Luchi, to discuss the biopharmaceutical company and its future outlook. http://www.immunepharma.com/ NEW YORK, Oct. 27, 2016 /PRNewswire/ -- Immune Pharmaceuticals (NASDAQ:IMNP) (STO: IMNP) (Immune) announced today that it has received guidance from the United States Food and Drug Administration (FDA) on a phase III study for Ceplene in combination with low dose IL-2 for the maintenance of remission in patients with Acute Myeloid Leukemia (AML). Ceplene/IL-2 has previously been approved in Europe and Israel following a successful phase III study with Leukemia Free Survival as the primary endpoint. The proposed phase III study design reviewed by the FDA focuses on overall survival as the primary endpoint, along with key secondary endpoints, including Leukemia Free Survival. The FDA also provided feedback relating to specific design elements of the phase III study, and with this framework, Immune plans to submit the final protocol for the phase III study in early 2017 and, upon approval, proceed with conducting a global Phase III Pivotal Overall Survival Study in AML maintenance of response with Ceplene/IL2. "We are very pleased with the positive outcome of our recent interaction with the FDA. Our path forward to proceed with a pivotal study following regulatory guidance of Ceplene/IL-2 meets our goal to address the urgent unmet medical need for remission maintenance therapy in AML," stated Monica Luchi, MD, Immune's Chief Medical Officer. About Immune Pharmaceuticals Inc.: Immune Pharmaceuticals Inc. (NASDAQ: IMNP) applies a personalized approach to treating and developing novel, highly targeted antibody therapeutics to improve the lives of patients with inflammatory diseases and cancer. Immune's lead product candidate, bertilimumab, is in Phase II clinical development for moderate-to-severe ulcerative colitis as well as for bullous pemphigoid, an orphan autoimmune dermatological condition. Other indications being considered for development include atopic dermatitis, Crohn's disease, severe asthma and Non-Alcoholic Steato-Hepatitis (NASH), an inflammatory liver disease. Immune recently expanded its portfolio in immuno-dermatology with topical nano-formulated cyclosporine-A for the treatment of psoriasis and atopic dermatitis. Immune's oncology pipeline includes Ceplene® which is in late stage clinical development for maintenance remission in Acute Myeloid Leukemia (AML) in combination with IL-2. Additional oncology pipeline includes Azixa® and crolibulin, Phase II clinical stage vascular disrupting agents, and novel technology platforms; bispecific antibodies and NanomAbs™. Maxim Pharmaceuticals Inc., Immune's pain and neurology subsidiary is developing AmiKet™ and AmiKet™ Nano™ for the treatment of neuropathic pain. For more information, visit Immune's website at www.immunepharma.com, the content of which is not a part of this press release.
Просмотров: 2808 BGN - Blockchain Global News
IPPCR: FDA Product Regulation
 
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IPPCR: FDA Product Regulation Air date: Tuesday, February 16, 2016, 5:00:00 PM Category: IPPCR Runtime: 01:12:37 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to http://clinicalcenter.nih.gov/training/training/ippcr1.html Author: Chris Joneckis, Ph.D., FDA Permanent link: http://videocast.nih.gov/launch.asp?19488
Просмотров: 1280 nihvcast
Case Report Form Design, Strategy & Standards Trailer
 
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The phrase “garbage in, garbage out” can be applied to the data collection efforts in clinical trials. To avoid this pitfall, it’s important to be thorough in the evaluation of the data collection items that will validate the protocol hypothesis endpoints and statistical analysis. It’s also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that the data are in compatible format. With this goal in mind, it’s essential for data collection to be consistent, concise and compatible – hence the need for standards. CDISC and CDASH are instrumental in the establishment of these standards. This web seminar will discuss the timing of Case Report Form (CRF) design in relation to clinical trial startup and the team that will contribute to the data collection recommendations. We will review the resources utilized in determining what data collection is required and the current standards – CDISC and CDASH – for CRF data content. Best practices for CRF design as documented by the Society for Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP) will also be presented.
Просмотров: 2586 Kathy Barnett
Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
 
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The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. Presenting the FDA with a coherent and clear integration of the data from your product development program is imperative and requires a sound strategy and a skillful approach.
Просмотров: 2766 RhoInc1984
What's in an IND? Guide to Writing IND For Biologics
 
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This talk was presented by Dr. Zahra Shahrokh, a NINDS consultant at STC Biologics. Dr. Shahrokh addresses the requirements to file an Investigational Drug Application for a biologic therapy and describes the different sections of the IND with a focus on therapeutic proteins. The presentation ends by providing examples of common deficiencies and mis-steps that Sponsors are likely to make.
Просмотров: 4655 NIHNINDS
About FDA’s Data Standards Program
 
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CDER’s Data Standards Program is explained via a musical analogy which outlines the data standards requirements in the drug development process. Data standards are helping the FDA streamline and modernize the drug review process which will benefit everyone. Learn more about FDA’s Data Standards Program at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/default.htm.
Просмотров: 2555 USFoodandDrugAdmin
Creating Define.xml 2.0 with OpenCDISC
 
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A CDISC Define.xml file is central to any electronic FDA submission — yet FDA reviewers report that the majority they see are rife with problems. They don't have to be. OpenCDISC Enterprise 2.5 gives you the tools to create FDA-compliant Define.xml 2.0 files in a snap. This enables easier transmission of metadata for CDISC SDTM, SEND and ADaM datasets … and, ultimately, faster time to market.
Просмотров: 14352 Pinnacle 21
IPPCR: Clinical Trial Registration and Results Reporting
 
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IPPCR: Clinical Trial Registration and Results Reporting Air date: Monday, April 4, 2016, 5:00:00 PM Category: IPPCR Runtime: 00:21:33 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to http://clinicalcenter.nih.gov/training/training/ippcr1.html Author: Deborah Zarin, M.D., Director, ClinicalTrials.gov Permanent link: http://videocast.nih.gov/launch.asp?19593
Просмотров: 2145 nihvcast
Highlights of "What Errors are Lurking in your Data" Webinar | Medidata
 
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What if you could use sophisticated AI to identify outliers, errors, anomalies and trends in your clinical trial data? Schedule a detailed, complimentary demo to see Medidata Edge Trial Assurance in action: https://mdso.io/2rFYdon To help Life Sciences organizations rethink how clinical trials can be more efficient, Medidata is introducing innovative ways to increase transparency and minimize risk of failure. Medidata applied AI to the clinical trial data and helped resolve 48 unidentified issues before submission, leading to direct FDA approval. A competitor that did not leverage this service received an FDA request for additional information, significantly delaying their drug's launch. With Edge Trial Assurance we can now identify risks in real-time -- during the clinical trial process and before submitting for FDA approval. Our team of former FDA reviewers leverages AI to increase transparency, helping you to identify and proactively resolve issues. Learn more: https://mdso.io/eta Read the Geeks Talk Clinical blog: http://bit.ly/2mUihCQ Connect with us on LinkedIn: http://bit.ly/2nbkrtJ Follow @Medidata on Twitter: http://bit.ly/2lBkYJf Like us on Facebook: http://bit.ly/2lUBkrv
Просмотров: 124 Medidata Solutions
Developing Monitoring Plans for Investigator-Initiated Clinical Trials - November 14, 2017
 
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Sandra SAM Sathers, MS, BSN, CCRA, CCRC presented a ReGARDD educational seminar entitled "Developing Monitoring Plans for Investigator-Initiated Clinical Trials" on November 14, 2017 at the Duke University School of Medicine. This event was organized by the Office of Regulatory Affairs and Quality in collaboration with ReGARDD (ReGARDD.org).
Просмотров: 341 Duke University School of Medicine
IPPCR 2016: Data Management & Case Report Form Development in Clinical Trials
 
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IPPCR 2016: Data Management & Case Report Form Development in Clinical Trials Air date: Tuesday, February 02, 2016, 5:00:00 PM Category: IPPCR Runtime: 00:59:51 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to http://clinicalcenter.nih.gov/training/training/ippcr1.html Author: Marge Good, RN, MPH, OCN, NCI, NIH Permanent link: http://videocast.nih.gov/launch.asp?19463
Просмотров: 5533 nihvcast
Bridging Studies // Accelerating Development With Existing Evidence
 
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Ken Phelps, Camargo president and CEO, spoke on the use of clinical and nonclinical information for NDA approval at the Drug Information Association’s 50th Annual Meeting. Specifically, Ken addressed the topic of bridging studies — using existing public data and germane evidence to bridge into information necessary for new products to be approved. About Camargo Pharmaceutical Services Camargo Pharmaceutical Services provides full-service drug development through the 505(b)(2) process. While its rewards are abundant, the 505(b)(2) process presents unique and demanding requirements — you need the specialists at Camargo to help you identify a differentiated product and guide you from concept through commercialization. With 3-5 pre-IND meetings per month, worldwide reach in 26 countries and a client referral rate of 95 percent, it's easy to see how success breeds success. Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulating and testing the drug product, to conducting clinical studies and FDA application submissions. Connect with Camargo on LinkedIn, the president's blog or visit www.camargopharma.com for more information.
Просмотров: 491 Camargo Pharmaceutical Services
CDISC/SDTM - The emerged Global Data Standardization Practices
 
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In drug development process the importance of high quality and accessibility of clinical data is not only a best practice but a critical mission to adhere. In today’s world clean & arranged data offer real opportunity to design better studies using existing data and to plan safety strategies. The ultimate outcome of the clinical trials is directly related to parameters like collection, storage and easy retrieval of the data. To match the global data standards along with its high integrity, specificity and quality, the processes must be in-line to meet the regulatory requirements and CDISC/SDTM standards. The use of CDISC/SDTM standards enables sponsors to conduct rapid, time efficient and cost effective clinical trials. This webinar will cover 1. Data standardisation requirements – Regulatory perspectives 2. Advantage of adopting CDISC data standards 3. Bioequivalence study data submission requirements
Просмотров: 368 Lambda Therapeutic Research
Protocol Deviations: Documenting, Managing & Reporting Trailer
 
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According to both U.S. regulations and the ICH Good Clinical Practice: Consolidated Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval/favorable opinion from the IRB/IEC, except when necessary to eliminate an immediate safety issue for research subjects. However, unapproved protocol deviations occur in every study and at every site. There is a growing recognition within the industry as to the importance of appropriately managing protocol deviations. This web seminar provides tips and strategies to help participants anticipate, manage, and minimize the impact of protocol deviations. Investigators and Clinical Research Associates (CRAs) will learn how to appropriately document and report protocol deviations, with a focus on preventing recurrence. Internal study team members will learn how to implement a structured approach to managing significant deviations that impact subject safety and/or data integrity.
Просмотров: 388 Kathy Barnett
Bay Area CDISC Network Meeting 2015 04 30 Webinar Recording
 
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Recording of the Bay Area CDISC Network meeting held on April 30, 2015. Includes presentations by Ron Fitzmartin and Lilliam Rosario of the FDA, Patricia Gerend of Genentech, Lisa Brooks of Iris Statistical Computing, and various attendees of the PhUSE Computational Science Symposium in March. The meeting was hosted by Genentech, TalentMine, and PharmaStat. Ron Fitzmartin was a co-author of the new Guidances on electronic submissions, which establish the framework and start the clock for requiring standardized data in submissions. He will explain how the Guidances and specifications work, how they relate to each other, and how to determine the effective dates of requirements for your studies. Lilliam Rosario, Director of the Office of Computational Science, will talk about CDER’s JumpStart program, a service to modernize regulatory review by implementing standards-based processes and software tools to aid review. It’s hard to overstate the importance of these developments for those of us in the trenches, planning our next submissions. The Guidances are making CDISC standards a requirement, and JumpStart is already making them indispensable to reviewers. Meeting Agenda: Electronic Submissions - The Requirement for Standardized Study Data Ron Fitzmartin, PhD, MBA, Office of Strategic Programs, CDER JumpStarting Regulatory Review Lilliam Rosario, Ph.D., Director, Office of Computational Science, CDER Inspection Site Selection Data Standards Patricia Gerend, Principal Statistical Programmer Analyst, Genentech, Inc., A Member of the Roche Group News from the FDA/PhUSE Computational Sciences Symposium Sandra Minjoe, Accenture John Brega, PharmaStat Lisa Brooks, Iris Statistical Computing Phuong Dang, Genentech Attendees of the conference
Просмотров: 327 Bay Area CDISC Network
Clinical Trial Data Quality - Part 2
 
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Ekaterina Kholodkova, Synergy's DM&BS Head explains the basics of Data Management in clinical trials and shares her experience in improving the quality of data in clinical trials in Russia. Presentation at the conference PharmMedObraschenie - 2012.
Просмотров: 137 Synergy CRO
Finding New Ways to Collect Clinical Trial Data (Part 2) | Medidata
 
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Eric Morrie, associate director of clinical solutions at Wincere chats with Medidata's Claribel Pichardo for the conclusion of our 2-part video interview. In this clip, Eric shares his thoughts on the recent Medidata Symposium and where he thinks the industry is heading. From focusing on the patients and ePRO tools, to innovative mHealth devices, we're finding new ways to collect data in clinical trials. But we also need to make tools easier and continue to invest in technological advancements. || What is Medidata? || Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. || Our Products || Our fully integrated software suite supports your full journey through the clinical research process from beginning to end. Explore all the products we have to offer: http://ow.ly/nEgv30cKFcf || More Medidata|| SUBSCRIBE: http://ow.ly/NkMq30cKFzj Visit our WEBSITE to learn more: http://ow.ly/vCiP30cKFsD Connect with us on LINKEDIN: http://ow.ly/xMx130cKF8E Like us on FACEBOOK: http://ow.ly/d1V830cKEYD Follow us on TWITTER: http://ow.ly/8gMl30cKF5Y Read our BLOG: http://ow.ly/Esvz30cKFaF Find your next CAREER: http://ow.ly/QJn730cKFhN || Questions?|| CONTACT our sales and support teams by email or phone: http://ow.ly/rsDT30cKFvY MESSAGE us directly: http://ow.ly/zSXh30cKFug
Просмотров: 190 Medidata Solutions
Protocol Deviations: Documenting, Managing, and Reporting Trailer
 
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According to both U.S. regulations and the ICH Good Clinical Practice: Consolidated Guideline, Clinical Investigators are required to conduct a clinical trial in compliance with the investigational plan/protocol. Protocol deviations should not be implemented without sponsor agreement and the prior approval/favorable opinion from the IRB/IEC, except when necessary to eliminate an immediate safety issue for research subjects. However, unapproved protocol deviations occur in every study and at every site. There is a growing recognition within the industry as to the importance of appropriately managing protocol deviations. This web seminar provides tips and strategies to help participants anticipate, manage, and minimize the impact of protocol deviations. Investigators and Clinical Research Associates (CRAs) will learn how to appropriately document and report protocol deviations, with a focus on preventing recurrence. Internal study team members will learn how to implement a structured approach to managing significant deviations that impact subject safety and/or data integrity.
Просмотров: 236 Kathy Barnett
The Critical Role of CMC in Your IND Submission
 
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Click here to register for free and to view the entire webinar: http://xtalks.com/CMC-in-IND-Submission.ashx?utm_source=Youtube&utm_medium=Teaser&utm_campaign=XTO834_ABC Speaker: Glenn E. Petrie, Ph.D., Senior Scientific Advisor, ABC Laboratories Early stage drug developers generally have their sights firmly set on the initiation of clinical trials, focusing on toxicological and pharmacological studies. Often, the importance of Chemistry, Manufacturing and Control (CMC) data is underestimated. But the CMC package is critical to IND approval, and meeting all FDA requirements demands careful planning and sound execution. This discussion will focus on the primary CMC requirements for a biopharmaceutical IND submission. It will cover the risk/reward criteria for determining the level and degree of method validation, reference standard characterization and formulation; as well as potential pitfalls and ways to streamline the entire development process.
Просмотров: 539 Xtalks Webinars
Innovative Clinical Trials Consultancy
 
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Innovative Clinical Trials Consultancy Pty Ltd is an Australian based company that specialises in advancing clinical trials research, for sites involved in the recruitment of patients to clinical trials. We have dedicated staff with extensive years of experience in clinical trials, including site management, study initiation, single-site lead ethics submissions, site-specific assessment regulatory approvals, patient recruitment, trial auditing, etc. We offer specialised software and professional services, to assist you to maximise your potential and facilitate growth within your clinical trials unit.
Просмотров: 105 innovativeCTC
Introducing OpenCDISC Community 2 0
 
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Просмотров: 2090 Pinnacle 21
Kitov Reports KIT-302 Has Beneficial Effects on Kidney Function
 
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TEL-AVIV, June 24, 2016 /PRNewswire/ -- Kitov Pharmaceuticals (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late-stage drug development, today announced newly available data from its successfully completed Phase III study of KIT-302 suggest beneficial effects on kidney(renal) function. Damage to renal function is a serious side effect of NSAIDs. The Company's combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two U.S. Food and Drug Administration approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension. Further analysis of data obtained in the Phase III clinical trial, whose top line results were announced in December 2015,showed that celecoxib increased serum creatinine compared to placebo;impaired renal function is a major concern with nonsteroidal anti-inflammatory drugs (NSAIDs). In contrast, while amlodipine alone reduced serum creatinine (-2.55 umol/L), a greater reduction in plasma levels of creatinine was achieved in patients in the KIT-302 arm (-3.22 umol/L), suggesting better renal function. Additional data supporting the conclusion that KIT-302 is beneficial to renal function were measurements of peripheral edema, a known side effect of calcium channel blockers, such as amlodipine. Peripheral edema was reported in 15.6% of patients receiving amlodipine but in only 8.2% of patients receiving KIT-302. These data suggest that KIT-302 protects against the widely recognized undesirable side effect of amlodipine in causing fluid retention by the kidneys. Dr. Paul Waymack, Kitov's Chief Medical Officer,said: "We are very pleased with the outcome of the renal function analysis. We believe it demonstrates that in addition to addressing hypertension side effects caused by celecoxib, KIT-302 also addresses fluid retention resulting from amlodipine: a known side effect caused by calcium channel blockers." "Given the potential marketing advantages of these findings,we intend to conduct a clinical trial designed to scientifically validate these beneficial renal effects in parallel with the New Drug Application we plan to submit at the end of 2016," stated Chief Executive Officer Isaac Israel. The study may also provide an explanation for the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302 was higher than that observed with amlodipine alone."
Просмотров: 345 CorporateProfile
CfPA's CMC Writing and Submission Strategies Course
 
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A look at CfPA Course Director Cheenu Murti presenting his course "CMC Writing and Submission Strategies ". This course will provide in-depth instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications in the US, Europe and Japan. To register for our US or Amsterdam course dates go to http://bit.ly/1Wc7xat
Просмотров: 1016 CfPA Center For Professional Advancement
Bay Area CDISC Network Meeting 2017-02-09 Webinar Recording
 
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Recording of the Bay Area Network meeting held on February 9, 2017. It’s about recent changes in submission requirements. As you may be aware, as of December 2016, new studies must be submitted to the FDA using CDISC standards. This recording features four presentations and a panel discussion regarding the new requirements by the FDA. Many thanks to Peng Yang at Clindata Insight, Dave D’Atillio at TalentMine and Jonathan Chainey at Genentech for co-hosting the meeting at the Conference Center, and for underwriting the cost. Meeting Agenda: How Will The New FDA Technical Rejection Criteria and Rejection Process Impact CDISC Data Submissions Kevin Lee, Clindata Insight Beginning December 18, 2016, all clinical trial and nonclinical trial studies must use standards (e.g., CDISC, eCTD) in the FDA Data Catalog. Beginning May 5, 2017, NDA, ANDA, and BLA submissions must be submitted in eCTD format. In order to put these mandates into a submission process, the FDA also released "Technical Rejection Criteria for Study Data" in FDA eCTD website on October 3, 2016. FDA will also implement a rejection process for submissions that do not conform to the required study data standards. Current State of the Study Data Standardization Plan and Legacy Data Conversion Plan & Report Jane Lozano, Eli Lily Jane provides background information on the plans and the current status of the template creation and associated deliverables. Both are described in the Technical Conformance Guide and FDA is looking to PhUSE to create the deliverables. What is new in the Study Data Technical Conformance Guide This Year Lisa Brooks, Iris Statistical Computing Recent Changes in FDA Submission Requirements from a Sponsor’s Perspective John Brega, eCTD Submission Strategy Consultant, PharmaStat, LLC Panel Discussion Reuben Jenkins from Omnicia, Kevin Lee, Lisa Brooks, John Brega
Просмотров: 185 Bay Area CDISC Network
Clinical Data Management - Infoset
 
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http://infoset.co i-CDMS is an innovative cloud based EDC offering a complete set of features for streamlining trial monitoring and data entry with e-CRF, automated edit checks and queries resolution, patient and site reporting, real time notifications and reminders and others. i-CDMS has been built with the latest technology tools and state of art user interface consisting a fully qualified EDC for supporting all types of trials. from the investigators and the wide advantages it offers in monitoring and control of clinical trials. Today i-CDMS is the #1 choice of many sponsors due to its easiness of use, its quick adoption from the investigators and the wide advantages it offers in monitoring and control of clinical trials. i-CDMS has passed full system validation in accordance with international regulations and complies to 21 CRF part 11 and HIPAA requirements. i-CDMS is accessible via the internet without any other special requirement or installation needed at the site. - Electronic Data Capture (eCRF) - Autos save functionality. - Discrepancies tracking - Audit Trail - Randomization & Blinding - Safety - Risk Based Monitoring - CDISC standards (SDTM and ODM) - Patient Recorded Outcomes - Electronic signatures - Accounting Integration - SDV - HIPPA compliance
Просмотров: 4703 Infoset
Danone Implementation of Medidata Patient Cloud ePRO | Medidata
 
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Gerald Neveau, data manager at Danone Research, speaks about operationalizing Patient Cloud ePRO in their clinical studies. View this fact sheet: https://www.mdsol.com/sites/default/files/PC_PatientCloudOffering_20160203_Medidata_Fact-Sheet_English.pdf || What is Medidata? || Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. || Our Products || Our fully integrated software suite supports your full journey through the clinical research process from beginning to end. Explore all the products we have to offer: http://ow.ly/nEgv30cKFcf || More Medidata|| SUBSCRIBE: http://ow.ly/NkMq30cKFzj Visit our WEBSITE to learn more: http://ow.ly/vCiP30cKFsD Connect with us on LINKEDIN: http://ow.ly/xMx130cKF8E Like us on FACEBOOK: http://ow.ly/d1V830cKEYD Follow us on TWITTER: http://ow.ly/8gMl30cKF5Y Read our BLOG: http://ow.ly/Esvz30cKFaF Find your next CAREER: http://ow.ly/QJn730cKFhN || Questions?|| CONTACT our sales and support teams by email or phone: http://ow.ly/rsDT30cKFvY MESSAGE us directly: http://ow.ly/zSXh30cKFug
Просмотров: 539 Medidata Solutions
IPPCR 2015: Conceptual Approach to Survival Analysis
 
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IPPCR 2015: Conceptual Approach to Survival Analysis Air date: Monday, November 16, 2015, 5:00:00 PM Category: IPPCR Runtime: 01:30:11 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to https://ippcr.nihtraining.com/login.php Author: Laura Lee Johnson, Ph.D., FDA Permanent link: http://videocast.nih.gov/launch.asp?19321
Просмотров: 18952 nihvcast
What Is The Difference Between an IND and a NDA in Clinical Research
 
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What Is The Difference Between an IND and a NDA in Clinical Research To get more content like this, follow me on SnapChat username is DanSfera I am only uploading a few of these SnapChat exclusive videos on to YouTube so make sure you don't miss out! http://www.TheClinicalTrialsGuru.com Call/Text: (949) 415-6256 Follow Me On: SnapChat: username is dansfera Instagram: https://instagram.com/dansfera Twitter: https://twitter.com/TheRealDanSfera Facebook: https://www.facebook.com/dansfera LinkedIn: https://www.linkedin.com/profile/view... LinkedIn Clinical Trials Guru Leaders Group: https://www.linkedin.com/grp/home?gid...
Просмотров: 1516 Dan Sfera
Drug Lifecycle Tracking Application DLTA
 
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Manage Entire Drug Life Cycle with DLTA. DLTA is unique solution for the Pharmaceutical Industry, CROs, Research and Regulatory Organizations. Track the entire process from Research, Drug Development, Trials, FDA interaction, Approval, Inspections and to the Post Market Surveillance .
Просмотров: 101 Aurotech DLTA
NHLBI Small Biz Hangouts: Conquering the (Regulatory) Basics | Navigating the FDA Website
 
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How do biomedical innovators begin to understand how FDA may regulate their novel technology? It turns out there is a lot of useful information on FDA’s website – if you know how and where to look. You can find out how the FDA is organized, and where your technology is likely to be reviewed; access (redacted) approval documentation for similar technologies to help inform your development strategy, and find resources – including guidance documents, webinars, slide decks, and case studies – developed to help innovators understand FDA’s regulatory approach. Chapter 1: Introduction 00:00 Chapter 2: Learning Objectives 02:33 Chapter 3: Website demonstration FDA homepage 04:56 Chapter 4: Website demonstration LEARN pages 08:11 Chapter 4: Website demonstration Guidance Documents 12:12 Chapter 5: Website demonstration FOIA Reading Rooms 13:28 Chapter 6: Small Business Office and Key Staff Contacts 21:35 Chapter 7: Q & A 32:30 Chapter 8: Signing up for Updates 33:54 Chapter 9: Q & A 38:04 Chapter 10: Website list and Contact Information 45:46
Просмотров: 2796 NHLBI
IPPCR 2015: A Research Question and Implications for Efficient Clinical Trials
 
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IPPCR 2015: A Research Question and Implications for Efficient Clinical Trials Air date: Monday, October 19, 2015, 5:00:00 PM Category: IPPCR Runtime: 01:34:45 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to https://ippcr.nihtraining.com/login.php Author: John H. Powers, III, M.D., NIAID, NIH Permanent link: http://videocast.nih.gov/launch.asp?19250
Просмотров: 15991 nihvcast
How Technology Can Improve Clinical Development Processes | Medidata
 
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While at the Society for Clinical Data Management (SCDM) conference in Chicago, we had the pleasure of catching up with Elizabeth Mandel, senior project clinical data manager at Genentech. In this video, Elizabeth talks about attending her first ever SCDM event, how technology can help improve clinical development processes and reconciling data from electronic data capture (EDC) databases to safety systems. || What is Medidata? || Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. || Our Products || Our fully integrated software suite supports your full journey through the clinical research process from beginning to end. Explore all the products we have to offer: http://ow.ly/nEgv30cKFcf || More Medidata|| SUBSCRIBE: http://ow.ly/NkMq30cKFzj Visit our WEBSITE to learn more: http://ow.ly/vCiP30cKFsD Connect with us on LINKEDIN: http://ow.ly/xMx130cKF8E Like us on FACEBOOK: http://ow.ly/d1V830cKEYD Follow us on TWITTER: http://ow.ly/8gMl30cKF5Y Read our BLOG: http://ow.ly/Esvz30cKFaF Find your next CAREER: http://ow.ly/QJn730cKFhN || Questions?|| CONTACT our sales and support teams by email or phone: http://ow.ly/rsDT30cKFvY MESSAGE us directly: http://ow.ly/zSXh30cKFug
Просмотров: 454 Medidata Solutions
Clinical Information Reconciliation (CIR)
 
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Learn all about CIR and how to perform the reconciliation within ChartMaker® Clinical in this video.
Просмотров: 524 STI Computer Services
Assessing Opportunities for Risk-Based Monitoring in Emerging Global Regions (Part 2) | Medidata
 
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Many clinical R&D experts have expressed concern regarding quality and performance of investigative sites in economically emerging global regions, due to relative lack of GCP experience as well as language and cultural barriers. The concern has risen to the level of questioning whether risk-based monitoring can be safely applied to studies conducted in emerging regions. In part two of this 3-part video series, Medidata's Steve Young shares compelling results from a quantitative analysis of site quality by global region that Medidata recently conducted, leveraging the vast operational metric data available in the Medidata Insights database. || What is Medidata? || Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers' clinical trials. Medidata's advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. || Our Products || Our fully integrated software suite supports your full journey through the clinical research process from beginning to end. Explore all the products we have to offer: http://ow.ly/nEgv30cKFcf || More Medidata|| SUBSCRIBE: http://ow.ly/NkMq30cKFzj Visit our WEBSITE to learn more: http://ow.ly/vCiP30cKFsD Connect with us on LINKEDIN: http://ow.ly/xMx130cKF8E Like us on FACEBOOK: http://ow.ly/d1V830cKEYD Follow us on TWITTER: http://ow.ly/8gMl30cKF5Y Read our BLOG: http://ow.ly/Esvz30cKFaF Find your next CAREER: http://ow.ly/QJn730cKFhN || Questions?|| CONTACT our sales and support teams by email or phone: http://ow.ly/rsDT30cKFvY MESSAGE us directly: http://ow.ly/zSXh30cKFug
Просмотров: 97 Medidata Solutions
IPPCR: Quality Management in Clinical Research
 
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IPPCR: Quality Management in Clinical Research Air date: Monday, February 29, 2016, 5:00:00 PM Category: IPPCR Runtime: 00:57:04 Description: The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research. The course focuses on the spectrum of clinical research and the research process by highlighting epidemiologic methods, study design, protocol preparation, patient monitoring, quality assurance, and Food and Drug Administration (FDA) issues. For more information go to http://clinicalcenter.nih.gov/training/training/ippcr1.html Author: Elizabeth Ness, R.N., M.S.N. Permanent link: http://videocast.nih.gov/launch.asp?19521
Просмотров: 2538 nihvcast
SAS Clinical Online Training
 
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For full curriculum and details contact training@serigor.com or call us at +1-443-687-9600 Visit us at http://www.showtheropes.com OR http://www.serigor.com Course Details: In this course, you will learn basics and advanced SAS concepts to read and manipulate clinical data. Using the clinical features and basic concepts of clinical trials, this course shows how to import ADAM, CDISC or other standards for domain structure and contents into the metadata, build clinical domain target table metadata from those standards, create jobs to load clinical domains, to validate the structure and content of the clinical domains based on the standards, and to generate CDISC standard define.xml files describing the domain tables for clinical submissions. Training type: Online Duration: 4-5 Weeks Batch Timings: Morning, Evening and Weekend batches available Who should attend? Bioinformatics or Life Science Graduates Job aspirants with basic understanding of clinical concepts or statistics SAS Clinical Data Integration organizes, standardizes and manages clinical research data and metadata. It provides the foundation you need to ensure standard, trusted clinical data to support strategic analyses, such as cross-study and advanced safety analysis. With SAS, you can gain both speed and efficiency by automating repeatable clinical data integration tasks. Class size is limited—sign up for this course today! What you'll learn? BASE SAS and Advance SAS: Basic SAS Concepts Referencing files, setting Options, Editing and debugging SAS Programs Creating List Reports and Enhanced List and summary reports Creating SAS data sets from raw data Understanding DATA step processing Creating and applying user defined formats Producing descriptive Statistics Creating and managing variables Reading SAS Data sets Combining SAS data sets Transferring Data with SAS functions Generating Data with DO loops and processing variables with Array Reading Raw Data in fixed fields Advanced Base/SAS: Macros and Proc Sql Clinical Programming Explanation of organizational aspects of the Biometrics department Basic concepts of Clinical trials Phase -- I, Phase -- II, Phase -- III, Phase -- IV Clinical trial glossary -- Demystified Explanation of the Clinical trial process Protocol development CRF Design and development, Data Management plan Edit check specifications document, Edit check programming Data querying, Paper CRF and E-CRF studies Database programming and basic understanding of EDC studies Annotated CRF's Data Querying Lab data handling -- procedures and pitfalls Patient Profiles, Database Lock CDISC SDTM 3.1.2 and ADAM 1.2 Implementation How to generate Tables, Listing and Figures For full curriculum and details contact training@serigor.com or call us at +1-443-687-9600 Visit us at http://www.showtheropes.com OR http://www.serigor.com
Просмотров: 1186 SAS CLinical Training
Webinar: Adaptive Trial Design & Incorporation of Biomarkers in Early Phase Clinical Studies
 
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https://wcct.com Hosted live on Friday, October 13th 2017. The desire to further expedite the development process has put a pressure on drug developers to find ways in which to achieve even more objectives during early phase clinical trials. In the FDA’s Critical Path Initiatives, two of the most important strategies for increasing measurable clinical objectives were the employment of adaptive clinical trial designs and the use of biomarkers. In this webinar, two of WCCT’s industry experts discussed adaptive clinical trial designs and focused on strategies for achieving additional objectives through the inclusion of biomarker evaluation in early phase clinical trials. The adoption of biomarkers has been one of the most important initiatives in the FDA’s Critical Path Initiatives. David McIlwain, WCCT’s Scientific and Medical Affairs expert, demonstrated the effectiveness of biomarker evaluation in early phase clinical trials, focusing specifically on the inclusion of immunological biomarkers for the development of new vaccines. While the inclusion of multiple objectives in a single trial offers clear benefits for decreasing development time, potential concerns around increasing chances of observing spurious signals frequently exist. WCCT’s Vice President of Biostatistics, Kalyan Ghosh, responded to the relevant statistical issues that arise in this setting, and discussed strategies to ensure that valid statistical inferences can be drawn for each of the objectives. In addition to discussing strategies for developing protocols which will achieve maximum objectives in early phase clinical trials, WCCT provided examples from recent programs in which these strategies were implemented. Visit https://wcct.com/early-clinical-development/ for more information.
Просмотров: 358 WCCT Global