Over the last six months new guidance has been released by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) regarding ethics committee (EC) submission, decentralized trials, patient-focused drug development, electronic systems and computerized systems. Although some are in draft format, this regulatory guidance is (indirectly) helping to advance and enhance the use of eCOA e.g., maintaining data quality in decentralized trials or electronic submission to ethics committees.
In the webinar, the Clario eCOA Science team will share their interpretation of the new guidance and how the combination of these together with scientific input can help sponsors and biotechnology companies achieve a more patient-centric approach while maintaining data integrity in a flexible trial environment.
- Overview of new/changed guidances
- EU Clinical Trials Regulation (Jan 2023)
- FDA (Draft) Decentralized Clinical Trials for Drugs, Biological Products and Devices (May 2023)
- FDA (Draft) Q&A Document “Electronic Systems, Electronic Records and Electronic Signatures in Clinical Investigations: Questions and Answers (March 2023)
- FDA (Draft) Guidance Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (April 2023)
- EMA (Final) Guideline on Computerized Systems and Electronic Data in Clinical Trials (March 2023)
- How the new guidance could potentially help advance and enhance the use of eCOA/ePRO
- A deeper dive into the nuances of submission requirements for European Ethics Committees/IRB
Join this webinar to discover how the recent FDA & EMA regulations are helping advance and enhance electronic clinical outcome assessments (eCOA/ePRO).
Bryan McDowell, MSc, MBA, Vice President, eCOA Clinical Science & Consulting, Clario
In his role as VP, eCOA Science & Consulting, Bryan McDowell brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma-wide industry necessity for smarter drug & device development and life cycle management.
Dr. Kelly Dumais, PhD, Director, eCOA Science and Consulting, Clario
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient-reported outcomes (PROs) to support labeling claims. She is currently the Director of eCOA Science and Consulting at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
Dr. Valdo Arnera, MD, Medical Scientific Advisor and General Manager, Geneva Office, Clario
A medical doctor by training, Dr. Valdo Arnera has over 35 years of experience in the pharmaceutical industry. Starting his career as a clinical pharmacologist in a Ciba-Geigy’s daughter company, he then founded the first European Central clinical laboratory dedicated to clinical trials, SciCor (now Covance central laboratory). Always passionate about how to improve the clinical trial process, Valdo joined PHT in 2000, and founded the European affiliate of PHT Corporation in January 2001. PHT was acquired by ERT in 2015 and then merged with Bioclinica to form Clario. Valdo has always taken care of the eCOA portion of Clario and is seen as one of the pioneers of the ePRO business.
Pierre-Frédéric Omnes, Regulatory Affairs Pharmacist and Executive Director, TransPerfect Life Sciences
Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences, is a regulatory affairs pharmacist with 21 years of experience in global Clinical Research Organizations and Pharmaceutical industry as Regulatory Affairs consultant (clinical trial regulatory operations).
Pierre supported for 15 years the coordination, support and oversight of numerous multinational clinical trial applications globally for New Chemical Entities, Biologics and Advanced therapies across several therapeutic areas. More recently, Pierre supported readiness activities around EUCTR implementation as EUCTR subject matter expert both within his company (department- and corporate-levels) and externally as consultant in EUCTR implementation initiatives for small, midsize and large pharma and CROs.
Since July 2019, Pierre is part of the EMA-led initiative developing the Clinical Trial Information System as Lead Product Owner representing the Industry and Academia stakeholders in that project, continuing an engagement of several years in the testing and optimization of CTIS.
Who Should Attend?
- Clinical Operations/Development/Research
- Clinical Scientists
- Clinical Data Managers
- Clinical Drug Development
- Clinical Program/Project Manager
- Clinical Trial Lead
- Sr. Manager, Trial Initiation
- Regulatory Affairs
- Data Science
- Digital Health
- Digital Operations
What You Will Learn
Attendees will gain an understanding of:
- The recent changes in European and US regulations
- How these new guidances have the potential to enhance and accelerate the use of eCOA/ePRO in clinical trials
- The nuances of submission requirements for European Ethics Committees/IRB
Clario is a leading healthcare research and technology company that generates the richest clinical evidence in the industry. Across decentralized, hybrid and site-based clinical trials, Clario’s deep scientific expertise, global scale and the broadest endpoint technology platform allows our partners to transform lives.