Decentralized clinical trials deliver time and cost efficiencies at nearly every point of the clinical research journey. In this session, you’ll learn about 14 value measures that IQVIA analysts used to showcase the positive trends and impacts seen by using a combination of DCT technologies and in-home support to streamline trial operations.

But sponsors don’t have to overhaul their entire protocol to reap significant benefits. Strategic deployment of tools like eConsent and eCOA can on their own strengthen engagement, workflow efficiencies and trial outcomes, IQVIA leaders will show through case studies and more.

Speaker:

Bhausaheb Patil
Head of Business Operations, Decentralized Clinical Trials
IQVIA

Vinita Navadgi
Senior Director, Product & Strategy, Patient Consent
IQVIA Technologies

• Overview of Risk Management aspects from ICH GCP and applicable regulations applicable to DCT
• Quality Risk Management (potential risks and mitigation actions) in Real World Data/Tokenization
• Key highlights of “EMA Guideline on computerized systems and electronic data in clinical trials”
• Risks and potential mitigation actions when using computerized systems in clinical trials

Speaker:

Paloma Faim Dufresne
Associate Director, Risk Management (Quality Planning & Strategy)
Janssen Pharmaceutical Companies of Johnson & Johnson

The optimal clinical trial design is not a one-size-fits-all approach. It is a series of countless permutations and protocol designs that must be carefully tailored to deliver the best trial for the patient and the sponsor alike. Science 37 carefully examines all clinical trial options and elements needed for research—helping sponsors craft the best model to deliver value. From cost and time savings to improved diversity, risk reduction, and more, join a group of industry experts for a conversation on where Decentralized Clinical Trials are headed—and how to maximize ROI for all stakeholders. Join this webinar, and discover how to:

• Analyze different hybrid models to assess what is best for your clinical trial
• Evaluate the value that DCT delivers beyond time and cost savings
• And learn how to operationalize virtual sites to deliver a model that improves the experience for all

Speaker:

Darcy Forman
Chief Delivery Officer
Science 37

Debra Weinstein, MD
Vice President,  Internal Medicine
Science 37

• What is DCT
• Evolution of DCT
• Advantages of DCT
• What possible limitations/challenges will be faced during DCT

Speaker:

Rashida Rampurawala
Manager – Clinical Data Management
GSK

Engaging with patient advisors to influence clinical research design is the standard for industry innovators. Our ability to gain patient input in design, throughout the life of the study and at close-out is a way our industry can truly be patient centric.

This approach is available to our industry and being utilized today to enhance traditionally designed and decentralized research studies. The benefits are obvious, but the solutions have historically been challenging to design, operate, and scale. That is now changing via the intersection of participant engagement science, decentralization, and digital technologies.

This session will explore how you can utilize a novel technology-enabled approach to differentiate and optimize your research study to be more patient-centric.

Speaker:

Tripp Maloney
Manager, Listening & Linguistics
THREAD

• Intro to the PharmaLedger project & PL ecosystem
• Intro to clinical supply chain use case, the needs & requirements of the CSC
• The roadmap of the UC development
• Design decisions within the scope of the project & system functionalities
• Technologies enabling the UC
• Demonstration of the system (pre-recorded)
• Key lessons learned

Speaker:

Dr Kristina Livitckaia
R&D Project Manager, Information Technologies Institute (ITI)
Centre of Research & Technology - Hellas (CERTH), Greece

While not a new concept, decentralized trials (DCTs) are becoming more common across the biopharma industry. Adoption of DCTs accelerated due to the COVID-19 pandemic, and research suggests that more sponsors will likely use DCTs — or elements of DCTs — in future studies. One of these elements is direct-to-patient (DTP) supply, which gives patients the opportunity to receive their clinical supplies at home. Since use of DCTs is expected to increase, what can sponsors and clinical supply providers learn from past DCT/DTP experiences that will help them adjust their supply strategies in order to give patients the best trial experience moving forward? 

Speaker:

Nicole Gray
Director, Strategic Supply Solutions
Catalent

Neta Bendelac
Senior Director, Strategy
4G Clinical