5 Sponsor Contracting Issues That Delay Clinical Trials and How to Avoid Them

Timely execution of clinical trial agreements (“CTAs”) is essential to efficient study start up. Sponsors operate under tight timelines and typically have aggressive goals for study enrollment. The stakes are high and so are the barriers to CTA execution in many cases. Although contracting delays are often attributed to site review cycles or institutional policies, sponsors frequently contribute to these bottlenecks as well.

In my work negotiating CTAs for clients, I see several recurring issues that can stall negotiations or start things off on the wrong foot. The following sponsor-driven factors frequently extend negotiation timelines and, in many cases, are fully preventable with the targeted process improvements recommended below.

1.  Use of Overly Complex CTA Templates

Clients often come to me with legacy templates or forms they received from other consultants. Many of these templates are unnecessarily long, overly complex, or out of line with current industry standards. In many cases, these documents are designed for studies that differ significantly from the clinical trial at hand (for example, it is not unusual to see references to drug regulations in a device CTA). In addition to this misalignment of terms, the templates are often drafted without considering the site’s perspective. Such templates increase the likelihood of extensive redlines and prolonged site review. By anticipating where negotiations will likely focus, sponsors can assess key provisions to ensure they align with industry standards and site expectations.

Recommendations:

• Streamline CTA templates to ensure they are as clear and concise as possible. Some terms may need to be lengthy and complicated (e.g., indemnification), but others can often be written without multiple paragraphs or complex legalese.

• Reassess legacy templates to remove outdated or non-applicable provisions. If a section seems overly complicated or out of place, it may have been carried over from a different study or a prior trial team with specific concerns. Do not assume that every term is still needed.

• Cross reference other study documents where relevant. Deferring to the protocol, informed consent form, and HIPAA authorization not only simplifies the CTA but can also help avoid creating inconsistencies among various study documents.

• Start with the end in mind. If you know how most sites will respond to a particular term and where negotiations are likely to end, don’t waste time by starting with an aggressive position unless you care strongly about the issue and can justify it.

2.  Lack of a Defined Internal Review and Approval Process

Prolonged internal review cycles are a major cause of contracting delays. When drafts need to be routed through multiple teams, such as clinical, legal, regulatory, and privacy, significant time can elapse before a CTA is returned to the site. In addition, negotiations frequently stall when internal decision-making authority is unclear. These issues can be compounded when external consultants are involved, such as CROs or legal counsel, and the consultants lack clear guidance on what they are able to negotiate and what requires approval.

Recommendations:

• Establish a clear and consistent internal routing procedure for CTA reviews and consider designating a single point of contact responsible for coordinating and consolidating comments from various teams.

• Implement expectations with internal reviewers and any external consultants regarding turnaround times (e.g., two business days).

• Identify decision-makers for each major issue area and determine what contract positions require higher levels of internal approval.

• Provide consultants with clear instructions regarding key terms and contract approval requirements.

3.  Not Determining Fallback Positions Up Front

Experienced CTA negotiators know which terms are the most contentious and where the parties are likely to spend time negotiating. These typically include indemnification, IP, subject injury, publication, and data use. Without predetermined fallback positions on these critical provisions, each redline requires new internal alignment. This can create significant delays, especially when multiple teams need to weigh in separately. If a sponsor goes into CTA negotiations without considering acceptable back-up positions for key terms, they have missed a crucial opportunity to streamline the contracting process. For some sponsors, this will take the form of a detailed playbook with extensive options for acceptable language, and for other sponsors with limited resources it might simply look like conversations among appropriate stakeholders to talk through the most critical issues.

Recommendations:

• Establish “preferred,” “acceptable,” and “non-acceptable” positions for heavily negotiated terms. This should include establishing boundaries for complex provisions such as indemnification, as well as alternative timelines for required notifications.

• Use previous CTA negotiating experience to create a “playbook” or other resource reflecting acceptable language, key considerations, and positions requiring further approval. Continually update this resource as new issues arise during negotiations.

• Align internal stakeholders on fallback positions before negotiations begin to avoid delays later on.

4.  Failing to Anticipate Site-Specific Issues

Sponsors often take a one-size-fits all approach to contracting with sites, even though the sponsor might be contracting with large academic institutions and smaller health care facilities in the same trial. The contracting process and acceptable CTA terms often look very different among various sites. Large academic institutions often have defined policies and procedures that apply to CTAs and terms they require due to legal, insurance, or policy constraints (e.g., indemnification, subject injury, governing law). This is particularly true with state institutions. In addition, many sponsors fail to anticipate that sites often have separate internal review pathways that take place concurrently (e.g., one for the CTA, one for the budget, etc.).

In many cases, sponsors fail to consider the nuances of each site as they approach CTA negotiations. Often, they also fail to consider previous contracting experiences with a particular site. If the sponsor or its consultants have negotiated with a site in the past, prior contracting timelines, institutional preferences, previously negotiated terms, and any operational challenges should inform strategic planning for the current negotiation. In addition, institutional policies regarding contracting positions are often publicly available for large research institutions. When these factors are not considered in advance, negotiations often cycle unnecessarily.

Recommendations:

• Ask the site up front how the review process will work and whether there are any aspects of the review that require a longer lead time (e.g., budget approval).

• Review prior engagements with a site before circulating the CTA and consider using previously agreed-upon language where appropriate.

• Identify any issues that caused delays with a site in the past and try to address them proactively.

• Review available institutional policies and other information regarding key contracting positions. Understand the terms that deviate significantly from the CTA template and be prepared to respond to the site’s positions on these terms.

5.  Not Using Accelerated or Master Clinical Trial Agreements

Master CTAs are often an effective mechanism for reducing study start-up timelines. Many sponsors delay pursuing master CTAs because the initial negotiation requires additional effort and can be a heavier lift than a single-study CTA. However, the long-term benefits, particularly for high-volume or strategically valuable sites, can be substantial. In addition, standardized CTA templates, such as the Accelerated Clinical Trial Agreement (“ACTA”), have been embraced by many institutions and can significantly cut down negotiating times. I typically caution sponsors that while the ACTA can be an acceptable starting point, several provisions require careful review and may require modification to align with sponsor needs.

Recommendations:

• Identify sites that would benefit from a master CTA based on study frequency, strategic priorities, or other considerations.

• If possible, negotiate master CTAs outside the constraints of an active study timeline and update master terms periodically to reflect evolving organizational or regulatory needs.

• If you are on a particularly urgent timeline and/or have limited contracting resources, consider using an accelerated CTA template or a modified version that accounts for key positions.

Conclusion

Sponsors can improve contracting timelines by addressing processes that commonly create avoidable delays. Streamlined review structures, clear decision-making authority, appropriate template design, strategic use of master and accelerated agreements, and an understanding of institutional norms all contribute to faster, more predictable site activation. Even modest improvements in these areas can significantly improve predictability and reduce site activation timelines.

If your team is navigating contracting delays or preparing for an upcoming clinical trial, London Legal Consulting can help. To discuss your needs or request a review of your current templates or workflows, please contact us.