September 16-17, 2021
Online Livestream
2nd Clinical TrialAgreements
Negotiate Budgetary Restraints, Protect IP and Clinical Data and Reduce Risks in Indemnification and Subject Injury in an Evolving Landscape
With clinical trial agreements setting the stage for the first step in the research process, identifying the risks and challenges within them prior to their signing remains crucial. These binding agreements are essential in protecting the data gathered throughout the trial while limiting potential risks. DGE’s 2nd Clinical Trials Agreements Conference offers a industry leading faculty ready to offer strategies best practices that will guide you throughout the negotiating process towards successful results.
Top Reasons to Attend
  • Hear the perspectives of sites, sponsors and CROs when negotiating these agreements
  • Implement methods for limiting company risk related to indeminification and subject injury
  • Compare and contrast domestic and international agreements
  • Network with industry leaders to discuss alternative methods in developing clinical trial agreements
Agenda at a Glance

Topics covered will include:

  • Data Privacy and Intellectual Property Challenges
  • The role of CROs in the contracting process
  • In-depth look at the negotiations between sites and sponsors
  • Telemedicine and its role in remote trial agreements
  • Patient recrutiement and non-disclosure agreements
Who Should Attend

Professionals of Biopharma and Medial Device companies working in the areas of:

  • Clinical Operations
  • Clinical Development and Analytics
  • Associate General Counsel
  • Contract Managers
  • Regulatory Officer
  • Clinical Research and Development
  • Compliance Officer
  • Global Site Agreements
  • Clinical Data
  • Site Development
  • Clinical Innovation
  • Business Development
  • Clinical Trial Manager
  • Project Leads
  • Program Manager
  • Supply Manager
  • Medical Affairs
  • Medical Operations/Documentation
  • Global Analytics
  • Internal Clinics
  • Clinical Project Manager
  • Medical Director
  • Quality and Compliance
  • Clinical Pharmacology
  • Ethics
Event Sponsors
New Topics
Featured Speakers
Brian Hunter
Director of Contracts & Trial Management
CNS Healthcare
Darshan Kulkarni
Pharm.D, MS, Esq.
Donald Louis Joseph Campodonico
Clinical Trials Contracts Officer I
Jeff Odom
Manager, Global Clinical Trial Contracts, Trial Capabilities
Eli Lilly
Jennifer Hennessy
Senior Counsel|CIPP/US
Foley & Lardner LLP
John Maloy
Assistant Vice Chancellor for Research Management
Louisiana State University Health Sciences Center
Kyle Faget
Foley & Lardner, LLP
Lynn Agata
Clinical Controls Manager
Stryker Neurovascular
Piotr Sławik
Senior Manager, Clinical Legal Advisor
Rikki-Quinn James-Renz
Director of Contract Administration
Supply Chain Services at Temple University Health System
Sandra Londono
Senior Contract Specialist, Icahn School of Medicine
Mount Sinai Hospital Medical School
Stephen Smith
Head, Global R&D
Sanofi NA
Tracie Carroll
Associate General Counsel
Event Schedule
Overcome the hurdles of negotiating a CTA through multi stakeholder discussion of some of the pain points. Partners from different backgrounds may be able to help inspire new ideas for reaching consensus.
  • Recognize the top challenges for sites; and sponsors
  • Underline the top negotiating points
  • Communicate your concerns
GDPR has been in effect for a few years, but the European Commission adopted new versions of the SCCs on June 4, 2021. What are the most important takeaways for CTAs? How quickly must you implement the new versions of the SCCs?
  • Summarize the purpose and key impacts of GDPR and the SCCs on CTAs
  • Analyze the impact on patient rights and consent management in particular
  • Clarify responsibilities of involved parties
  • Recent rulings and opinions on cross-border transfer of personal data
  • Timelines of new SCC adoption
  • Review and key aspects of the new SCC template
  • Ways to adjust and complete new SCC template appropriately to transfer setup
CTAs may struggle with data ownership, so this is an area you must always take pains to clarify. Each party must understand their responsibilities toward data confidentiality.
  • Stipulate ownership of clinical study results
  • Clarify publication rights
  • Determine the future use of subject data
  • Identify who is accessing what data
  • Minimize the risk of a data breach
  • Spell out ownership of samples and whether they can be used for other purposes
CTAs are incorporating virtual clinical trials and a reliance on telemedicine. While standards may be released at some point in the future, currently telemedicine can be difficult to navigate.
  • Evaluate state by state considerations and standards regarding telemedicine
  • Outline the risks involved in telemedicine and know what to account for
  • Uncover the requirements for informed consent via telemedicine

Gain insight on some of the critical issues involved in negotiating agreements internationally.

  • What do clinical agreements look like outside the US – EU, Australia, Canada, Asia-Pac
  • Use of CROs globally
  • Quality and effective data sharing across continents and compliance standard

A discussion of updates in site negotiations - Concerns and considerations. In this conversation we will:

  • Discuss emerging areas of negotiations for sites and sponsors
  • Reasonable considerations and language discussions in such negotiations
  • Areas of decreasing focus and reasons for such refocus
Post-COVID working conditions have brought many adjustments and operational changes to clinical trials. Adapting to that ever-changing landscape requires flexibility when crafting and modifying clinical trial agreements.
  • Keep an eye out for changes in logistics, safety issues and risks taken by sites and sponsors when things are fast tracked
  • Consider the impact on budget of remote monitoring, mobile nursing, and other staffing that may be required
  • Manage indemnification around decentralized trials
Contracting with third parties - including independent investigators, supplemental sites and CROs - introduces another layer of complexity into agreements. Gain an understanding of special provisions when contracting with multiple stakeholders.
  • Determine the impact of third parties on budgeting and contracts
  • Understand the patient privacy issues which may be at risk
  • Consider the types of indemnification that may be required from third parties into sites
It is critical to ensure that proper protections surrounding patient injury are in place in clinical trial agreements. This session highlights important recommendations on drafting subject injury language that protects sites and subjects.
  • Avoid conditional language
  • Hear about the implications of the Medicare Secondary Payer Rule
  • Discuss the best way to protect subjects’ rights to compensation
The indemnification clause should be consistent with subject injury scale and carve-outs. Take a close look at the risks and scopes typically involved.
  • Ascertain what is relevant to the particular study and indemnification obligations
  • Examine verbiage to ensure intent
  • Learn how indemnification around decentralized trials is being approached
  • Review what is typically carved out
  • Discuss Stark Law, Anti-Kickback Statute, False Claims Act and Medicare Secondary Payer Rule on clinical trial contracts
  • Recognize how the sponsor-CRO relationship impacts legal language
  • Avoid limiting terms within the agreement

Given the ever increasing complexity of clinical trial protocols, there is no “One Size Fits All” for payment terms in CTAs. The number and frequency of study visits, the technologies and vendors utilized in the collecting of study data, and pace of enrollment should all be considered during negotiations.

  • Adapt payment terms based to the protocol design and enrollment expectations.
  • Ensure adequate compensation for the work involved with screen fails.
  • Recognize work required outside of study visits and adjust the budget accordingly.
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