January 25-26, 2021
Online Livestream
Forum
Clinical TrialAgreements Forum
Negotiating Budgetary Restraints, Protecting IP and Clinical Data and Avoiding Indemnification while Preparing for New Methods of Testing
Days
Hours
Minutes
Seconds

Whether developing COVID-19 vaccines, testing orphan drugs, using biospecimens outside of a trial, or selecting CROs, much consideration must be given prior to entering a CTA.

DGE invites you to our Clinical Trial Agreements Summit – focused on the confidentiality of subject data and IP, indemnification and subject injury, an in-depth look at the increased use of telemedicine – and much more! This is the only industry event specifically devoted to this topic, made available through a proven interactive online platform.

Top Reasons to Attend
  • A look at the latest updates on Clinical Trial Agreements during the COVID-19 pandemic
  • Site perspective on the latest challenges they face when agreeing to clinical trial contracts
  • A look at risk involved surrounding indemnification and patient injury
  • The growing use of telemedicine as a part of these agreements
  • The use of third-party investigators in clinical trial agreements and the obligations they hold
Who Should Attend

Professionals of Pharmaceutical, Biologics, and Medial Device companies working in the areas of:

  • Global Site Agreements
  • Compliance Officer
  • Clinical Research and Development
  • Regulatory Officer
  • Contract Managers
  • Associate General Counsel
  • Clinical Development and Analytics
  • Clinical Operations
  • Medical Affairs
  • Supply Manager
  • Program Manager
  • Project Leads
  • Clinical Trial Manager
  • Business Development
  • Clinical Innovation
  • Site Development
  • Clinical Data
  • Ethics
  • Clinical Pharmacology
  • Quality and Compliance
  • Medical Director
  • Clinical Project Manager
  • Internal Clinics
  • Global Analytics
  • Medical Operations/Documentation

This Event is also of Interest to:

  • Law Firms
  • Patient Recruitment Specialists
  • Data Security, Analytics and Reporting Companies
Event Sponsors
Conference
New Topics
Featured Speakers
Alice Um Kope
Assistant General Counsel, Corporate Transactions
ATARA BIOTHERAPEUTICS
Donald Louis Joseph Campodonico
Clinical Trials Contracts Officer I
STANFORD UNIVERSITY SCHOOL OF MEDICINE
Jamie Valentine
Research Contracting Officer I
UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH
Jason Cline
Research Contracting Officer III
UNIVERSITY OF FLORIDA, OFFICE OF CLINICAL RESEARCH
Kyle Faget
Special Counsel
Foley & Lardner, LLP
Linda Reig
Partner
BUCHANAN INGERSOLL & ROONEY PC
Nicholas Zepnick
Senior Counsel
Foley & Lardner LLP
Piotr Sławik
Senior Manager, Clinical Legal Advisor
GILEAD SCIENCES
Sarina Rivera
Assistant General Counsel
GENENTECH
Sonia Kissi
Senior Director, Clinical Contracts and Outsourcing
INTERCEPT PHARMACEUTICALS
Tal Bar-El
Legal Counsel
TEVA PHARMACEUTICALS
Tammie Bain
Assistant Director, Industry Contracting
EMORY UNIVERSITY
Event Schedule
     

One of the most important things in developing a clinical trial agreement remains the language found within the contract. Even the smallest mistake can open the door to a huge amount of risk to a site or a sponsor. This session provides an in-depth look at the framework for these contracts.

  • Explore the language regularly seen within the contracts
  • Avoid limiting terms within the agreement
  • Differentiate the preferred terminology between sites and sponsors

Budget may be one of the first things discussed during clinical trial negotiations. Agreements must specify budgetary guidelines within the total amount allotted to the trial, as well as how this money will be dispersed.  

  • Ensure the budget for the testing falls with Fair Market Value (FMV) 
  • Set the terms for the release of funding to the site
  • Amend the contract for an expanded budget and why this may be needed
  • Understand the relation of a trial’s budget to the review of case report forms

COVID-19 still remains the focus on all clinical trial professionals. With the approval of a couple of vaccines (and more to come) and hospital staff being first to be vaccinated, hope of the impact of COVID-19 being reduced to happen soon is on the horizon. But prior to COVID-19 no longer being an issue on clinical studies, what considerations were given to the contracts?

  • Look at the impact of the guidance issued by the FDA in relation to COVID-19

  • Evaluate how the terms of an agreement and study procedures have changed to allow for impact of COVID-19 on clinical studies

  • Confront how has the COVID-19 pandemic has changed clinical trial agreements

When one clinical trial concludes, another begins. There can be occasions in which biospecimens remain from a previous trial that are a fit for the next. Prior to their use, sponsors must include the proper language in multiple agreements with participants to avoid any type of fiscal penalties. This session explores what must be agreed upon prior to additional uses of these biospecimens. 

  • Review HIPAA privacy rules surrounding biospecimens
  • Fold biospecimen rights into informed consent documentation 
  • Center the confidentiality of identifiable protected health information

Secrecy remains the top priority of pharmaceutical and biologics manufacturers when contracting with sites. Incorporating clauses within clinical trial agreements to protect a sponsor’s right remains crucial to control shared information.  

  • Assess the site’s participation in drafting the protocol in the clinical trial agreement
  • Scrutinize U.S. patent law to ensure the sponsor retains ownership of the IP
  • Prepare for the full gamut of associated time limits and costs

With clinical trial agreements holding stringent confidentially terms between sites and sponsors, it is important to understand the rights of each.  You can improve confidence on trial results by making certain the contract features firm clauses protecting a sponsor’s IP.  

  • Incorporate confidential disclosure agreements into the overall agreements
  • Distinguish between Investigator Initiated Trial vs. Sponsor-Authored Trial
  • Define terms surrounding electronic medical records
  • Emphasize a site’s right to publish findings
     

Negotiating directly with a sponsor is quite different from having a CRO negotiate on the sponsor’s behalf.  While they are third-party organizations, their representation of the sponsor can have a large effect on all other parties involved. 

  • Incorporate terminology to protect the trade secrets of the sponsor into the contract
  • Understand the sponsor’s definition of “poor performance” by the CRO, and the effect this holds on the contract
  • Determine protections are offered to the sponsor when they are represented by a CRO

Nothing is a bigger risk in the clinical trial space than subject injury. Should participant face any sort of harm, both the site and sponsor can be held responsible. Ensuring that the proper protections are placed in the contract are what protects you from potentially facing huge financial penalties. 

  • Prepare the necessary informed consent documentation
  • Outline the institution’s role to offer an acceptable standard of care
  • Incorporate clauses for compensation within the contract

Currently, no type of testing is being used more than telemedicine. While COVID-19 has slowed a lot of research, technology allows these essential tests to continue. However, regulations have changed surround clinical trials in this form and it is crucial that your agreements meet the regulations which have been put into place.  

  • Analyze the state regulations surrounding virtual Clinical Trial Agreements 
  • Alter a CTA to transition to telemedicine
  • Evaluate the use of virtual clinical trials during the COVID-19 outbreak
  • Guide sites to conduct the proper testing virtually
Register Now

This window is secured by 256 bit encryption on a PCI compliant network. Click here to view this window in its own page.

Subscribe to Conference Updates
Join our e-newsletter list to follow closely all news.
Event Partners
15
Speakers
21
Days
251
Participants
125
Workshops
90
Venue
Contact Us