In November, clinical trial platform developer Medable raised $91 million in private funding, amid the COVID-19 pandemic that touched off huge demand among pharmaceutical companies looking to initiate “siteless” or virtual clinical trials. In May of this year, Science 37, received $200 million in PIPE funding, announced a merger, and its plans to be a major public listing on Nasdaq in 2021. Provider of the one of the industry’s first Decentralized Clinical Trial Operating System, the company has penned deals with the likes of Medgate, Signant Health and Duke Clinical Research Institute to offer virtual trials.

Those are just a few examples of companies stepping up to facilitate decentralized clinical trials. These trials can offer several advantages for pharmaceutical companies, including the ability to recruit patients who can’t travel to physical sites to participate in research, become more cost-efficient and enable the enhanced use of telehealth in clinical trials.

We’ll explore the role of CROs in siteless trials and the opportunities and challenges for CROs to expand their capabilities in this burgeoning area.

Topics include:

  • Best practices for choosing and providing user-friendly equipment that patients in clinical trials will need to participate in virtual trials.
  • Overcoming operational challenges that can arise when patients participate in virtual trials, for example by using hybrid models that incorporate in-home visits from nurses and other clinicians.
  • How to work with participants to ensure the security of data that’s transferred from wearables and other equipment used in their homes to clinical trial investigators.

Featured Speaker

Darcy Forman

Chief Delivery Officer
Science 37

Darcy Forman is the Chief Delivery Officer for Science 37, where she has responsibility and oversight for clinical operations service delivery, including patient engagement, clinical operations, data management, and nursing solutions.

Darcy has more than 20 years of experience bridging clinical operational expertise and strategic corporate development initiatives with a passion for innovative and decentralized clinical trial execution. Most recently, Darcy served as the vice president of corporate development at Firma Clinical Research, where she had oversight and leadership responsibility for the identification, development, and execution of corporate development opportunities, including the evaluation of Firma corporate strategies and strategic planning. Darcy started her career at Pfizer Pharmaceuticals as a bench scientist before transitioning into a role in Pfizer’s clinical research division.  She continued her career with ascending clinical operations and project management positions at various CROs spanning large, mid-size, and niche including i3 Research (now Syneos Health), Health Decisions, Clinipace, and Firma Clinical. During her career, Darcy has fostered her passion for innovation and intelligent operational strategy by bringing metric-driven decision making to each role and organization. Darcy holds a B.A. in chemistry from Lake Forest College.

Sanskriti (“Sans”) Thakur

Chief Growth Officer

Sanskriti (“Sans”) Thakur is Medable’s Chief Growth Officer and is focused on market expansion and growth initiatives to advance the company’s vision of human-centered research, enabling remote access to clinical trials regardless of geography, income, and race. She most recently served as global life sciences research lead for Accenture, responsible for market-shaping strategy and research in therapeutics, digital health, and business model innovation. During her 18 years in the life sciences industry, Thakur has advised more than 30 companies, launched 10 products, advised digital health venture funds, and managed a leading pharmaceutical portfolio. She has authored 12 publications on various industry topics, and currently serves on the World Economic Forum global futures council for healthcare topics.

Ravi Ramachandran

Vice President and Head of Product and Technology
PPD® Digital

Ravi Ramachandran is vice president and head of product and technology for PPD® Digital. In this role, he oversees the product and technology function supporting the delivery of digitally enabled and decentralized/virtual studies. Ravi is a digital technology veteran focused on the clinical trials space. He has successfully created and led digital technology groups at various organizations in the biopharma sector, including iCarbonX, Apellis Pharmaceuticals and Vertex Pharmaceuticals, as well as working at PatientsLikeMe.  Ravi and his teams have helped implement multiple digital technology solutions across multiple therapeutic areas to help answer the fundamental question of medicines development: “Is the drug acting on the intended target in the target organ at the right time?”  His diverse exposure to pharma, biotech, digital therapeutics, patient advocacy and now the CRO space provides him with a multifaceted lens when solutioning for technology to help support digital and decentralized trials. Ravi thrives on collaboration and working cross-functionally to ensure the delivery of the optimal mix of solutions for customers, while always keeping the patient in mind.

Nicole Gray

Director, Strategic Supply Solutions
Catalent Clinical Supply Services

Nicole Gray is currently Director, Strategic Supply Solutions for Catalent Clinical Supply Services, responsible for developing the Direct to Patient business and other new strategic service offerings.  She has been in the Pharmaceutical industry for 18 years and has held multiple roles in clinical supplies project management.  Prior to moving to her current role in August 2018, Nicole spent 6 years as the Director of Project Management for the Catalent Philadelphia site, responsible for a team of 45 Project Coordinators, Project Managers, and Sr. Project Managers.  Prior to moving to Catalent Philadelphia, Nicole was responsible for the Mt. Laurel and Allendale Project Management teams (previously Aptuit).

Prior to joining Catalent, Nicole held various project management, communications and marketing coordination roles at Omnicare Clinical Research, GE Financial Assurance, and the United States House of Representatives. 

Nicole is an active member of the Global Clinical Supplies Group (GCSG).  She is currently the Vice Chair for the 2022 US Conference and previously held both the US Conference Secretary & Board Secretary roles.