Virtual clinical trials, a reliance on telemedicine and remote monitoring have brought many changes to clinical trials. Adapting to the ever-changing landscape requires flexibility when crafting and modifying clinical trial agreements. DGE’s 3rd Clinical Trial Agreements Forum is designed to walk you through important changes impacting CTAs including incorporating cybersecurity language, more complicated indemnification, complexities of third party contracting and an increase in remote monitoring. The conference agenda provides insight into industry best practices and legal and technological trends impacting success plus ways to expedite contracting and study start up.
- Hear about strategies to effectively and efficiently manage negotiation timelines
- Gather best practices for overcoming the top challenges for sponsors and sites
- Consider the types of indemnification that may be required from third parties into sites
- Outline risks in telemedicine and decentralized trials and uncover requirements for informed consent
- Strengthen tactics for incorporating cybersecurity language in CTAs and remote monitoring agreements
Topics covered will include:
- Incorporate cybersecurity language in CTAs and remote monitoring agreements
- Adapt contracts for monitoring plans which accommodate decentralized trials
- Reduce bottlenecks and negotiate additional provisions and site budgets innovatively
- Ensure vendor compliance with CTA cybersecurity
- Recognize the top challenges in negotiating CTAs from sites and sponsors
Professionals of Biopharma and Medial Device companies working in the areas of:
- Clinical Research
- Clinical Contracts
- Clinical Operations
- Clinical Development and Analytics
- General/Senior Counsel
- Site/Global Site Agreements
- Regulatory Officer
- Clinical Compliance
- Supply Manager
- Clinical Project Manager
- Medical Director
- Quality and Compliance
- Clinical Pharmacology
