Managing Risk in eClinical Technologies and Decentralized Clinical Trials (DCTs)
Choose Your Adventure, While Sticking to the Plot
Join our webinar on Tuesday May 10th
7am Pacific – 10am Eastern – 3pm UK – 4pm Central Europe
E-Technologies add potential opportunities and risks to clinical research, but a lack of familiarity can be a barrier to their use in decentralized trials. Sponsors need to know “What good looks like” for each technology or service provider and need reassurance that newer technologies, or their providers, will not invalidate trial results or fail to deliver operational value. But most trial Sponsors lack suitable RFI questionnaires to evaluate providers, or even clarity about what questions to include.
This webinar will cover the perceived and actual risks that concern trial sponsors when considering using eClinical services, especially in support of decentralized trials. Expert speakers with significant experience within sponsors and quality auditing will share their experiences and answer questions on problems arising – and innovative solutions – for the effective selection and qualification of eClinical service providers.
The webinar will also introduce an innovative solution using latest industry standards to evaluate vendors objectively for:
- eHealth Records
- Electronic Clinical Outcomes Assessment (eCOA)
- Electronic Informed Consent (eIC)
- Electronic Regulatory Binders/Electronic Investigator Site Files (eISF)
- Electronic Trial Master Files (eTMFs)
- Interactive Response Technologies/Interactive x{Telephone/Voice/Web} Response System (IRT/IxRS)
- Mobile cardiac monitoring
- Mobile HCP visits
- Telemedicine
- Wearable Devices/sensors
- Digital design
Who should attend
This webinar will benefit VPs, Directors and Managers in clinical trial sponsors responsible for:
- Quality Assurance
- Clinical Operations
- Vendor/Outsourcing Management
- Compliance/Regulatory Management
- Directors/Heads of Innovation
It will also hold useful insights for Contracts, QA and Compliance staff at clinical trial service providers
Managing Risk in eClinical Technologies and Decentralized Clinical Trials (DCTs)
Choose Your Adventure,
While Sticking to the Plot
Hear honest advice and put your questions to our panel of clinical research quality experts
Jennifer Sessions,
Senior Director, Diligent Pharma
Jennifer has over 20 years of experience in clinical research, mostly with Eli Lilly and Company. Most recently, she served as the CEO of Cynvec, a private biotech company focused on cancer therapies.
Jay Turpen,
Head of Client Services with Diligent Pharma
Jay leads a team of staff and Auditors that implement a risk-based qualification service for clients of Diligent Pharma. He has been in the pharmaceutical industry for 32 years and has held various leadership roles. Jay has a wealth of experience in GMP, GLP, and GCP environments with significant real-life experience in developing numerous new drug candidates.
Joseph Kim,
Chief Marketing Officer for ProofPilot
Joseph Kim brings over 23 years of pharmaceutical research expertise including a leadership role in Lilly’s Digital Health Office and as Chief Marketing Officer at ProofPilot. His industry knowledge across all phases of clinical research draws on experiences with Shire and Merck, CROs and technology vendors. His well-known history of innovation in the industry was recognized by the “Top 100 individuals on the 2015 MedicineMakers Power List”.
Joseph Schenk,
CEO at Quality Bridge
Joseph has over 30 years of quality improvement, computer validation and project management experience working for FDA regulated (GxP) processes. He has conducted 175+ audits of CROs, software vendors and other GxP suppliers.
Put your questions to our expert panel!
Ask our speakers for their comments on any specific questions –
Simply email marketing@diligentpharma.com
Key Learning Objectives
- The perceived and actual risks that concern trial sponsors when considering eClinical services, especially in support of decentralized trials
- How to focus on the big picture as a sponsor and reach more patients
- Challenges and solutions when assessing the quality of eClinical service providers
- The latest, industry-leading standards for eClinical service providers
- How to identify all potential risks of new technology providers with a standardized approach