Guest Column | June 20, 2024

When Site Start-Up Goes Wrong: 4 Contracting Pitfalls To Avoid

By Karl Dorwart, vice president, head of healthcare, life sciences, and consumer staples, Factor

Business important announcement-GettyImages-1410062638

Clinical trials are crucial for advancing science and giving patients access to life-saving treatments, yet one of the top causes of delays is frequently underestimated: the role of contracting as a prerequisite to getting trials off the ground. Inefficient contracting processes can hinder negotiations with academic, medical, and community research sites and stall or even derail site start-ups.

To accelerate trial timelines, biotechs must prioritize efficient contracting procedures and processes to navigate what can be thousands of nuanced clinical trial agreements (CTAs), particularly when multiple jurisdictions are in scope. Without a robust contracting ecosystem and process, in-house teams are often overwhelmed, leading to bottlenecks compounded by inconsistent and unsustainable contracting practices that can negatively affect site start-up. And when multiple jurisdictions are involved, these bottlenecks can multiply.

As a quick fix, many companies turn to expensive law firms or external resourcing providers — solutions that may offer short-term relief but do not address the underlying lack of a sustainable contracting process. Cue frequent escalations and a high number of contract handoffs during negotiation, along with insufficient data, delayed starting points, and lengthy negotiation cycles. And shifting research conditions and priorities can further slow contracting operations, impeding the progress of clinical trials. 

This article explores four common pitfalls in site start-up, with strategies to get clinical trial negotiations back on track, empowering biotechs to reduce delays, cut costs, increase standardization, and enable the faster commencement of more clinical trial sites — ultimately improving patient outcomes. 

1. Underestimating Jurisdictional-Specific Contracting Requirements

Biotechs often underestimate the complexity of navigating legal and regulatory frameworks across different jurisdictions. This can lead to significant delays, sanctions, or fines for non-compliance, especially when managing multinational Phase 3 trials that involve various legal entities and regulatory bodies. 

Some countries have national templates, which are subject to ongoing updates and modifications. If a biotech company doesn’t update its library of templates by regular cadence, a state-run institution may refuse to enter into a contract. Other jurisdictional nuances can add more red tape problems: In the U.K., for example, a U.S.-based sponsor must have a legal representative in the U.K. to liaise with patients and regulatory authorities. Additionally, the new EU Clinical Trial Regulation requires all clinical trial documentation to be submitted through the European Clinical Trials Information System (CTIS), while additional ethical committee (EC) approvals are needed for each jurisdiction, requiring detailed knowledge of local regulations and requirements — and the capability to navigate local EC approval processes for each jurisdiction. 

Moreover, compliance with General Data Protection Regulation (GDPR) requirements is essential when performing clinical trials in Europe, adding another layer of complexity.

It’s no surprise that a clinical team can quickly become overwhelmed when faced with setting up trials in multiple priority countries without specific knowledge of each country's regulations and jurisdictional red tape. 

The Solution: Codify Country-Specific Knowledge With Human- And Tech-Enabled Knowledge Artifacts 

Biotechs should prioritize developing a robust understanding of the diverse regulatory environments, establish processes that are scalable and adaptable to these differences, and codify this knowledge in the form of documented templates and playbooks. It starts with ensuring access to the right human expertise with specialist contracting knowledge in the target geographies, which can be directed to build and maintain these essential knowledge artifacts.

Leveraging AI-enabled contract life cycle management (CLM) technology can further streamline the contracting process across jurisdictions by managing amendments to country-specific templates. But while a CLM system is extremely beneficial as a repository for jurisdictional-specific templates with the mandatory legal language and clauses, experts are needed to track and update regulatory requirements and codify knowledge from previous country-specific — and site-specific — negotiations. This approach ensures that valuable insights are retained and applied, making it easier to reference and incorporate lessons learned in future contracts and ultimately resulting in cumulative contracting efficiency.

By combining the technological capabilities of an AI-enabled CLM system with the nuanced understanding of human experts and efficient processes, biotechs can navigate the complexities of multijurisdictional contracting more effectively, ensuring compliance, reducing delays, and accelerating the start-up of clinical trials. 

2. Overlooking Data Gaps That Amplify Contracting Bottlenecks — And Not Leveraging Learnings To Improve Site Engagement 

Critical legal complexities — particularly in many Phase 3 trials — can prompt lengthy negotiations over issues including, but not limited to: intellectual property, publication rights, biological samples, indemnification provisions, limitation of liability, and country-specific provisions. 

While the creation of playbooks, clause libraries, and templates can help anticipate site pushbacks and reduce the number of escalations, a data-driven approach to maintaining these enabling artifacts is often lacking. 

Biotechs with limited reporting capabilities lose critical data around cycle times, resource capacity, and negotiation rounds. For example, when the majority of redlines are not captured in the playbook, their value in reducing escalations effectively is limited.

The Solution: Capture Data And Learnings While Getting The Work Done, Enhancing Current And Future Site Engagement 

It starts by shifting from a mentality around simply executing the work at hand to one of building a sustainable process by systematically capturing and applying current learnings to improve site engagement, both immediately and in the future. Among other vital data, this includes granular metrics on structure and processes, such as: 

  • Escalation Pathways: Who reviews the escalations? What are the typical sources of site negotiations?
  • Information Access: What are the methods to efficiently codify the information? Where do contract managers find information? 
  • Team Involvement: How many layers of reviews are involved in the contracting process? 

Additionally, it is essential to refine playbooks and templates to accurately reflect the most common redlines in real-time, which can make a significant impact on reducing escalations. 

3. Neglecting Relationship Management With Sites Failing To Build Trust

Effective clinical trial contracting involves more than just handling legal documents — it's about fostering strategic partnerships with a variety of stakeholders, including site investigators, CROs, regulatory authorities, review boards, site administrators, and more.

Failing to develop and maintain strong relationships with these stakeholders can hinder the negotiation process, affecting trial timelines and outcomes. Clinical research sites' biggest hang-ups with CTAs often revolve around complex legal language, inflexible terms, and slow responses to contract queries. A go-between contracting culture — with several layers of intermediaries between negotiating parties — can further jeopardize relationships and stall the progress of site start-up. 

The Solution: It’s A Relationship, Not A Contract

To improve interactions with trial sites, biotechs should consider adopting a relationship management mentality, starting with assigning a dedicated person (point of contact) to each site. This approach facilitates consistent and transparent communication and quicker resolution of issues. The dedicated lead should have a problem-solving mindset to manage and leverage historical data, including legacy site-specific escalations and corresponding resolutions, to streamline negotiations. This includes capturing site-specific deal-breakers and fallback clauses, which helps in anticipating and addressing potential issues efficiently.

When site negotiators trust the contracting team, they are more likely to be flexible and cooperative, reducing resistance and making it easier to reach agreements. In turn, site negotiators can provide valuable insights into common issues and site-specific preferences, which can be used to refine contract templates and playbooks.

By prioritizing relationship management and assigning dedicated contracting professionals, biotechs can ensure smoother negotiations, foster stronger partnerships, and ultimately accelerate the start-up of clinical trials. 

4. Using Inflexible Or Complex CTA Language

Inflexible contracting language can stall the start-up process. When contracting terms are unyielding to operational realities or regulatory requirements of the site, sites often push back — leading to prolonged negotiations. Rigid contract terms may also cause regional compliance issues and reduce cooperation and trust. 

Biotechs cannot embrace flexibility and standardization without the resources to codify contracting learning and to update and maintain that knowledge bank consistently. 

The Solution: Build And Maintain A Knowledge Bank 

Developing a library of standardized contract templates and clauses can significantly expedite the contracting process. This entails creating and maintaining a repository of redlines, common negotiating positions, and fallback options to streamline negotiations, cloning terms from previously executed agreements to save time. This repository should be updated regularly based on real-world negotiations, minimizing the need for escalations and speeding up contract execution. Training staff effectively to these standards and implementing a managed contracting environment will support faster initiation of studies and a more efficient overall contracting process.

Flexible contracts that can be customized to meet unique site-specific requirements will increase the velocity of the overall contracting execution and site start-up process. Best practice leverages insights from past negotiations to drive efficiencies while leaving room to adapt necessary updates to the legal clauses.

Involve site representatives, regulatory experts, and legal teams early in the contract development process to ensure that the language meets all stakeholders' needs and regulatory requirements. Drive continuous improvement by regularly updating contract templates and playbooks.

Think Ecosystem, Not Individual Executed Agreements 

In the rush to get sites launched, companies often “brute force” contracting activities, deploying internal and external resources against the transactional business of finalizing executed contracts. Avoiding the common pitfalls of site delays requires adopting a process approach. Building a sustainable, efficient, repeatable contracting “ecosystem” that encompasses expertise, data, tools, and knowledge artifacts — along with practical technology enablement — is key.

By recognizing and addressing the common mistakes in clinical trial contracting and implementing innovative solutions, biotech companies can enhance their operational efficiency, reduce delays to site start-up, and deliver new lifesaving treatments to patients faster. This strategic approach to contracting is essential for sustaining growth and innovation in the biotech industry. 

About The Author:

Karl Dorwart is the vice president, head of healthcare, life sciences, and consumer staples at Factor, an integrated law provider that works alongside legal departments to manage complex transactional legal work. Factor specializes in providing biotech companies with the legal frameworks and operational processes that characterize mature legal teams.