Having a trusted source of communication is a key baseline for CTA development. Lack of communication between stakeholders can lead to longer negotiation timelines while increasing the number of misunderstandings and disagreements. Your team should realize what methods are best for improving communication between sponsors, sites, and CROs to streamline clinical trial agreements.
- Realize which methods of communication work best for each stakeholder
- Emphasize the importance of having a clear and concise language
- Improve the communication process to increase efficiency
CROs are being used as a vital “middleman” in almost every relationship between the site and sponsor. However, CROs can create unintentional miscommunications and increase time spent on clinical trial budget negotiation and contracts. Are CROs a necessary part of CTAs? If so, how can they become more efficient and help both the site and sponsor?
- Decipher the best ways to involve CROs in budgeting, timelines, and negotiations
- Explore the problems that arise while working with CROs
- Learn from past cases of miscommunication and inefficiency
One of the largest problems during CTA negotiations is site and sponsor communication. There are discrepancies regarding budgets, operations, and fair market value. Would these problems be easier to communicate about if there were a team of people who dedicated their time to understanding the site’s point of view?
- Categorize the problems that arise between sites and sponsors
- Address how communication transparency has helped many sponsors and sites have a healthier relationship
- Strategize how a site engagement team could help the sponsor and the site accelerate the negotiation process
As sponsors and trial sites routinely negotiate CTAs, certain provisions – like indemnification, data rights access, restrictions on publication, and more – pose particularly thorny issues. Your team should be able to identify up front the CTA provisions to watch out for, and market standard middle grounds that will yield a “yes” as quickly as possible.
- Address key factors leading to slowdowns such as negotiators lacking necessary information, options, or decision-making authority
- Prioritize accuracy and reduce risk without missing deadlines by using strategies such as targeted “2nd reviews” of key provisions and first drafts from less experiences negotiators
- Examine how the sponsors, sites, and CROs can contribute to a faster negotiation process including by selecting the most efficient template, explaining the “why” behind edits, and participating in effective negotiation meetings
This recent FDA guidance includes recommendations on the use of digital health technologies (DHT) to acquire data remotely. DHTs can increase efficiency for sponsors and sites to make research more convenient. How can these DHTs be employed in a study? Is there a legal risk when using DHTs in CTAs or informed consent?
- Go over the recent FDA guidance on DHTs in order to understand how to properly utilize them
- Debate the legal risk involved in DHTs when going over informed consent
- Identify how DHTs can improve the efficiency of clinical trial data acquisition
Clinical trial budget negotiation can be a hot-button topic. Sites and sponsors consistently have different budgets and must go through an extensive negotiation process in order to reach a compromise. How can sponsors and sites see eye-to-eye on this issue? How can your team be prepared to accelerate these negotiations to reach a mutually beneficial conclusion?
- Identify the miscommunications between sites and sponsors regarding budget
- Recognize the best ways to keep lines of communication open
- Discuss how overhead and with-holdings contribute to a disconnect between sponsors and sites
Fair market value changes throughout different states, and this can increase prices at different sites. Understanding fair market value can be a challenge. What is being utilized when determining fair market value? How is this data being collected?
- Discover how fair market value can be calculated and how this impacts stakeholders
- Identify the ways that fair market value influences clinical trial budget negotiation
- Understand how sites and sponsors can reach consensus
In order to avoid uninsured losses, your team should understand the disconnect between the language in CTAs and insurance contracts. Patients are often treated differently based on their specific kind of insurance. This can be unfair, and also create an uncomfortable position for the site when it must communicate those insurance provisions to the patient. Is it possible to create a language that will address any concerns patients have regarding their insurance?
- Identify insurance considerations for sponsors and sites
- Develop a specific language for sites to use when communicating with patients regarding their insurance coverage
- Evaluate the challenges related to synchronizing CTA and insurance language
In 2024, there will be a rise in decentralized clinical trials. CTAs must be modified to authorize the correct language for remote monitoring. During remote monitoring, sites are required to have home-health visits. This creates a burden on sites by requiring them to stretch their resources to accommodate remote monitoring as well as standard clinical trials. Will this impact the quality of remote monitoring staff and procedures?
- Address the challenges facing remote monitoring from the site and sponsor perspecive
- Discuss how fair market value does not differeniate in cases with remote monitoring
- Learn the correct language for including remote monitoring
The use of technology and AI has increased within the past few years. AI can now be used to enhance clinical contracting, review contracts, and accelerate the negotiations process. Is utilizing AI a good idea? Will using AI accelerate the contract review process, or add more steps? How can your team be prepared to answer these important questions?
- Explore the use of AI in contract review, specifically focusing on its ability to streamline the redlining process and revolutionizing how professionals approach contract evaluation
- Gain insights into the experience of organizations employing AI for contract review
- Delve into the expectations vs the reality of AI implementation
During clinical trial agreements, there are several things that can slow down the negotiation process. In order to streamline negotiations and meet entity goals, your team should realize when indemnification is appropriate, exceptions to indemnification, and much more.
- Choose the wording of your indemnification clause carefully
- Maximize returns and minimize liabilities
- Explain the affect of the entity type on the indemnification
- Go over any alternatives to indemnification
Clinical trial agreements play a crucial role in the landscape of mergers and acquisitions, particularly within the pharmaceutical and biotech industries. These agreements not only define the scope, budget, and timelines of clinical trials but also set forth important regulatory and compliance obligations that can impact the valuation and feasibility of M&A transactions.
- Explore the key considerations in M&A due diligence
- Discuss how to transform the landscape of CTAs through AI
- Go over the role of standard templates in streamlining clinical trials
International agreements can propose an entirely different set of challenges for CTAs. China has different regulations that can influence these negotiations and agreements. Is your team prepared to compare the regulations globally?
- Discuss the importance of ensuring data privacy while working on global CTAs
- Spotlight how regulations differ across regions and countries
- Visualize a global approach for CRO engagement
In the CTRA, sites sometimes reference that sponsors needs to abide by institution policies when on site for monitoring. These policies vary from site to site. Even if not referenced in the CTRA, when monitors go to sites, they are often asked to sign a contract regarding access to the site and often a second contract related to access to the EMR system. These forms cover issues like data ownership, indemnification, requirements for access, and protection of personal data.
- Understand how these policies vary from site to site
- Explain the importance of these policies and how they affect monitoring and GCP requirements
- Discover how these documents will impact the future of CTAs and what you can do to streamline negotiations
