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Decentralized trial solutions for complex clinical trials

Improving the patient experience while overcoming DCT challenges for a pediatric rare disease population

Making decentralized clinical trials a successful reality for the most complex studies is considered challenging, but not impossible. While the industry is finally adopting decentralized clinical trial (DCT) solutions, they are considered to be quite difficult to conduct given the many logistical and data collection challenges for therapeutics that target complex and rare diseases in narrowly defined patient populations.

Veristat shares their expertise and lessons learned from conducting 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. Join us as we share the strategies that were deployed to improve the patient experience.

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Shaheen Limbada

Shaheen Limbada

Executive Vice President, Innovation and Strategy, Veristat

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 Veristat's pharmacovigilance, commercialization, and decentralized clinical trial solutions.

Kim MacDonnell

Kim MacDonnell

Lead Clinical Research Associate, Veristat

Kim MacDonnell, BScN, MSc, RN, CGC, is 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 counseling 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 which was created for newborns screening positive for rare genetic conditions. She is a registered nurse in Ontario, Canada and South Carolina as well as a Certified Genetic Counselor by the American Board of Genetic Counseling.

ARSALAN ARIF
moderator

ARSALAN ARIF

FOUNDER & PUBLISHER, ENDPOINTS NEWS

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.