5 Sponsor Contracting Issues That Delay Clinical Trials — And How To Avoid Them

By Catherine London, JD, MPH, London Legal Consulting

Timely execution of clinical trial agreements (CTAs) is essential to efficient study start-up. Sponsors frequently operate under compressed timelines and strive to meet ambitious enrollment goals. While sponsors often attribute delays in CTA execution to site review cycles or institutional requirements, sponsor-side processes and contracting practices can meaningfully contribute to such delays.

There are several recurring sponsor-driven practices that often create friction early in the CTA contracting process. This article outlines five such practices that can extend negotiation timelines and unnecessarily hinder CTA execution. Many of these issues can be mitigated through more deliberate preparation, clearer internal processes, and contracting strategies that anticipate site expectations, as described below.

1. Use Of Overly Complex CTA Templates

Sponsors often rely on legacy CTA templates or forms from consultants without giving much consideration to the terms. Many of these templates are unnecessarily long, overly complex, or out of line with current industry standards. In some cases, these documents are designed for studies that differ significantly from the clinical trial at hand. For example, it is not unusual to see drug regulations referenced in a CTA for a device study. In addition to misalignment of terms, templates are often drafted without considering the site’s perspective (or the site-specific issues described below). Using such templates increases the likelihood of extensive redlines and prolonged negotiations. By anticipating where sites will likely push back, sponsors can assess key provisions up front to ensure they align with industry standards and site expectations.

Recommendations for sponsors:

• Streamline CTA templates to ensure they are clear and concise. 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• Reassess legacy templates to remove outdated or non-applicable provisions.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 another sponsor with unique concerns. Do not assume 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 most sites are likely to push back on a particular term and it is clear where negotiations are likely to end, do not waste time by starting with an aggressive position unless the issue is critical to the sponsor and can be justified.

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 compound 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 internal approval.

Sponsors should carefully define when issues need to be escalated and who has authority to make decisions. Not every redline warrants senior-level review, but strategically important sites or principal investigators may justify additional flexibility or faster escalation. Having clear escalation criteria helps negotiators distinguish between routine redlines and issues that require broader business or legal input. When escalation is needed, negotiators should ask the site to explain its rationale and, if applicable, share relevant policies or guidance that inform its positions. This creates a useful record, reduces back-and-forth, and gives internal reviewers the context needed to keep negotiations moving.

Recommendations for sponsors:

• 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.
• Set expectations with internal reviewers and external consultants regarding turnaround times.

• Identify decision-makers for each major issue area and determine what contract positions require higher levels of internal approval.
• Provide consultants with explicit instructions regarding key terms and contract approval requirements.
• Before escalating a site request, ask the site to provide its rationale to reduce back-and-forth and speed internal review.

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 the most time negotiating. Indemnification, intellectual property, subject injury, publication, and data use are all heavily negotiated provisions that are likely to be redlined by sites. Without predetermined fallback positions on 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 more limited resources it might be accomplished through conversations among stakeholders to talk through critical issues before they arise.

Recommendations for sponsors:

• Establish “preferred,” “acceptable,” and “non-acceptable” positions for heavily negotiated terms, including boundaries for complex provisions such as indemnification and alternative timelines for required reviews or 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.
• Ensure that contract negotiators understand what terms reflect regulatory requirements, sponsor “must haves,” or preferences. Clearly articulating the purpose behind various provisions helps negotiators understand where there is leeway and where the sponsor needs to remain firm.
• 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. However, the CTA review process and acceptable contract terms can look very different at large academic institutions versus smaller health care facilities. Larger 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, intellectual property, subject injury, data use restrictions). This is particularly true with state institutions that may be subject to state law limitations with respect to tort liability, indemnification, and insurance. Independent sites and site networks, by contrast, might have more flexibility to negotiate but can bring their own priorities, such as payment terms or turnaround times.

Sponsors also need to account for the fact that sites (particularly larger institutions) often have separate internal review pathways that occur in parallel for the CTA and the budget, often with different review teams. At these sites, it is particularly important to ensure that the CTA and budget terms are appropriately aligned as the parties negotiate payment timelines, effect of termination, and billing language. In many cases, sponsors fail to consider the nuances of each site as they approach CTA negotiations. Accounting for site-specific factors in advance helps ensure that negotiators are prepared to ask the right questions and modify terms where needed.

Recommendations for sponsors:

• Ask the site about key issues up front, including site structure, 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.
• Review available institutional policies and other information regarding key contracting positions. Understand which terms deviate significantly from the CTA template and be prepared to respond to the site’s positions on these terms.
• Draw on prior contracting experiences with a site and knowledge of institutional preferences and previous operational challenges, which can inform strategic planning for future negotiations. Identify issues that caused delays with a site in the past and try to address them proactively.

5. Not Using Master or Accelerated Clinical Trial Agreements

Using master CTAs can serve as an effective mechanism for reducing study start-up timelines. Many sponsors avoid 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 cut down negotiating times. However, while the ACTA can be an acceptable starting point, several provisions typically require careful review and modification to align with sponsor needs.

Recommendations for sponsors:

• Identify sites that could 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.
• For sponsors that are on a particularly urgent timeline or have limited contracting resources, consider using an accelerated CTA template or a modified version that accounts for key positions.

Conclusion

Sponsors can reduce avoidable contracting delays by taking a deliberate and proactive approach to CTA development and negotiation. More efficient contracting requires having tailored CTA templates, clear internal review processes, defined decision-making authority, and predetermined fallback positions. Understanding the nuances of each site also allows for better prepared negotiations to reduce friction and avoid bottlenecks. Addressing these issues before negotiations begin can help promote more predictable site activation while supporting timely study start-up.

Editor’s note: A version of this article first appeared on London Legal Consulting’s blog. It is republished here with permission.

About The Author:

Catherine London has over a decade of experience representing life sciences companies and health care providers on clinical research contracting and compliance matters, providing comprehensive legal support to sponsors, research institutions, CROs, and other stakeholders involved in sponsored research.

Catherine draws on her deep regulatory expertise to counsel clients nationwide on issues impacting clinical trials, including informed consent, IRB considerations, patient privacy, conflicts of interest, and risk management. She is well-versed in the laws, regulations, and industry standards governing clinical trials, including FDA requirements, the Common Rule, HIPAA, and Good Clinical Practice, as well as fraud and abuse laws, Medicare and Medicaid requirements, and transparency reporting requirements. Catherine employs this expertise to help clients navigate the intricacies of clinical trial agreements, ensuring that they align with regulatory requirements, protect business interests, and foster successful collaborations.