2 min read
Decentralized clinical trials (DCTs) are becoming increasingly popular to optimize patient engagement and retention. At the same time, making DCTs a successful reality for the most complex studies is considered difficult given the many logistical and data collection challenges for therapeutics that target complex and rare diseases in narrowly defined patient populations.
Listen to an Endpoints News and Veristat on-demand webinar: ‘Decentralized Trial Solutions for Complex Clinical Trials’. Veristat experts Shaheen Limbada, EVP of Innovation and Strategy, and Kim MacDonnell, Lead Clinical Research Associate, share experience and insights gained from conducting DCTs.
Shaheen Limbada discusses our evolved clinical trial approach for advanced therapies which takes the best elements from traditional, hybrid, and fully decentralized trial methodologies and incorporates them into a unified approach across the drug development journey.
Kim MacDonnell relates lessons learned from a natural history study for a rare pediatric disease, which not only included virtual components from the start but had to pivot mid-way to add in additional virtual visits during the pandemic lockdowns. This case study illustrates the challenges and flexible solutions that ensured the continued success of the study.
Learning points:
- The importance of optimizing patient participation in complex trials
- The challenges and solutions for implementing decentralized trials
- A real-world example of a decentralized trial that shifted mid-study
Meet the Speakers:
Shaheen Limbada
Executive Vice President, Innovation and Strategy
Shaheen Limbada is the Executive Vice President of Innovation and Strategy of Veristat. In this role, Shaheen oversees identifying and building strategic, innovative solutions to advance the clinical development goals of our clients. With over 22 years of experience running clinical trials, he excels in innovative clinical trial solutions, clinical trial execution, business strategy and business growth. He will initially be focused on applying his skills to enhance and build the Veristat pharmacovigilance, commercialization, and decentralized clinical trial solutions.
Shaheen spent four years as the Executive Vice President of Global Clinical Operations at Veristat, where he fully integrated new processes for adopting digital and virtual components to improve the patient experience of participating in clinical trials. He joined Veristat through the acquisition of Topstone Research, a Canadian-based CRO he co-founded, and held the position of Managing Director. Before Topstone, he worked in clinical operations, project management, and leadership roles at various clinical research organizations (CROs) and pharmaceutical firms, including Leo Pharma, Cetero Research, and AstraZeneca.
Mr. Limbada graduated from the University of Toronto and quickly began his career in clinical trials with AstraZeneca Canada Inc.
Kim MacDonnell
Lead Clinical Research Associate, Veristat
Kim is currently a Lead Clinical Research Associate at Veristat, overseeing the on-site execution of complex gene therapy trials in rare diseases. In addition to her work in clinical trial execution, she has extensive healthcare experience in genetic counselling and working with families and advocacy groups in the rare disease space.
Kim played a major role in the development of the Maritime Newborn Screening Program follow up to testing. This program was created to provide timely and accurate follow up for newborns screening positive for rare genetic conditions. Kim has a keen interest in providing de-centralized trial solutions to the rare disease population in hopes that their engagement in clinical trials will lead to understanding of their diseases and advancement of therapies.
Kim received her Bachelor of Science in nursing from Western University and her Master of Science in Genetic Counseling from McGill University. She is a registered nurse in Ontario, Canada and South Carolina as well as Certified Genetic Counsellor by the American Board of Genetic Counselling.