Everyday we hear about biopharmaceutical companies exploring novel and innovative approaches to conduct studies that will have a significant impact on cost savings, timelines, improve overall patent recruitment and retention, and also create a more meaningful patient experience. And while many companies have considered implementing a direct-to-patient clinical trial design (virtual trial), most have a watch and wait mentality, citing concerns over data quality, technological feasibility, drug safety, regulatory hurdles and more.
This webinar will provide a basic overview of what is involved in designing and implementing a virtual clinical trial and includes a discussion of important considerations and solutions. It will showcase how clinical trial participants have changed their behaviors with the adoption of technology and the pressure this puts on sponsor companies to innovate and decentralize clinical study designs.
Topics to be presented for this one hour webinar include:
- How clinical trial participants have changed their behaviors with high levels of technology adoption
- Sponsor efforts to innovate to reduce timelines and costs with the virtualization of clinical trials
- Protocol optimization & bringing in the voice of the patient into virtual trial study design
- How gathering feedback from patients provides important guidance on remote study designs
- How to select the right trial and the right patient population for a virtual trial
- Forward looking ideas to decentralize trials and add remote data collection elements into clinical study designs
Key Considerations when selecting a technology partner to deliver virtual/remote clinical trials will also be discused, such as,
- Regulatory compliance
- Patient privacy
- Technology designed to reduce (not add to) patient burden, such as wearable devices
- Shipping drug directly to the patient
- Ability to deliver important functionality to support virtual trials (telemedicine, medical record integration, eConsent, ePRO)
Learn from industry experts on how to bring the voice of the patient into the process to minimize burden and reduce timelines with the design of direct-to-patient, remote and virtual clinical trials.
Kai Langel,
Director, Janssen Clinical Innovations
For over 15 years, Kai Langel has been a pioneer in patient-facing systems for clinical trials. Through his involvement in technical operational and scientific roles, he has gained an in-depth understanding of all aspects of the patient journey from recruitment and engagement through data capture. His experience includes active involvement in providing guidance to sponsor companies and CROs on how to best operationalize innovative methods for direct-to-patient virtual clinical trials. As part of the Janssen Clinical Innovation team, Kai supports the company’s strategies for clinical trial innovation.
Abbe Steel,
Founder & CEO, HealthiVibe, LLC
Ms. Steel is the Founder and CEO of HealthiVibe, a company that offers a systematic, structured process for sponsors and sites to engage with patients at every stage: from clinical trial design all the way through post-approval activities and research.She founded HealthiVibe of her passion for patient engagement and firmly believes there are opportunities to improve clinical and commercial programs by making them more patient friendly. For over 25 years, Ms. Steel has been working in the life sciences industry, leading clinical development and post-marketing programs. She is an advisor to pharma sponsors in the design and implementation of patient-directed global programs that leverage data, insights and mobile/digital technology to satisfy patient/caregiver, provider, payer and regulator needs. Ms. Steel previously worked as Vice President of Patient & Physician Services at UBC-Express Scripts; worked at Sanofi on global marketing programs; was Senior Director, Patient Programs at PAREXEL; and was Vice President at a health IT start up. Ms. Steel received her Masters of Science in Health Communications from Boston University and her BA from George Washington University.
Doug Bain,
Founder & Chief Technology Officer, eClinicalHealth
Doug Bain is a Founder and the Chief Technology Officer of eClinicalHealth, the creators of Clinpal. For nearly 20 years Doug has worked with leading eClinical vendors in technical product management positions and in Operational Excellence roles. His experience spans the management of the IBM Clinical Trials Solutions Group product – ClinWare, and includes design and development strategy with DataTrak, TeamWorksTrialink, and eResearch Technology. In 2004, Doug founded the Medidata Solutions European office supporting the evolution of EDC and quickly transitioned to Vice President, Operational Excellence in a role where he defined the best practices, processes and methods for the deployment and execution of electronic data capture technologies for sponsors. At eClinicalHealth, Doug defines and manages the strategic direction of the Clinpal technology platform in the support of direct-to-patient and virtual clinical trials.
- Learn the value of collecting feedback, bringing in the voice of the patient to optimize decentralized clinical study designs
- Evaluate key considerations when selecting a technology platform to support direct-to-patient, remote and virtual studies
- Conceptualize “what’s on the horizon” for virtual and direct-to-patient clinical trial design
- Head of Virtual Trials
- Head of Clinical Operations
- Head of Innovation & Strategy
- Project Managers
- Project Directors
- Head of Information Technology
- Head of Real World Evidence
- Head of Patient Centricity
- Head of Patient Innovation
- Head of Medical Affairs
- Chief Technology Officer
- Head of Data Management
