Clinical contracts made simple: from red tape to green light

At Aixial Group when we work with Sponsors and sites, one theme consistently emerges: contracting takes longer than anyone would like. What should be a straightforward step too often turns into weeks — or months — of back-and-forth that delays study start-up and frustrates everyone involved. The good news is that it doesn’t have to be this way. By applying proven best practices, we can help Sponsors and sites cut through the bottlenecks, align expectations earlier, and move from draft to signature far more efficiently — without ever compromising compliance or quality.

Date: 21 October 2025 | Ref: ART011

As global regulations evolve, so too does the importance of getting contracts right the first time. With evolving ICH E6(R3) guidance, the emphasis on transparency, accountability, and clarity in study agreements is stronger than ever. Sponsors need partners with the global experience and foresight to navigate these requirements across therapeutic areas, and governance bodies.

Our playbook for clinical site agreements

Our Site Management Services (SMS) team manages every aspect of clinical site contracting with a focus on speed, compliance, and mutual trust. We combine standardised tools with a flexible, site-centric negotiation style, ensuring that agreements protect sponsor interests while remaining practical for sites to execute.

Key aspects of our approach include:

ICH E6(R3) Alignment – Incorporating the latest guidance to ensure contracts clearly define responsibilities, data ownership, safety reporting pathways, and transparency obligations.
Template-Based Efficiency – Leveraging regional and national frameworks and templates such as the model Clinical Trial Agreement (mCTA) in the UK, the Accelerated Clinical Trial Agreement (ACTA) in the US, and other countries national templates, while adapting to Sponsor-specific or institutional preferences.
Balanced Negotiation – Using fair market value benchmarks and transparent budgeting tools to streamline discussions and foster goodwill with sites.
Global Consistency with Local Sensitivity – Harmonizing contract structures across multi-country studies while respecting local laws, institutional norms, and cultural considerations.

Beyond site agreements: specialized contracting expertise

Clinical trials extend well beyond site-level contracts. Our team brings deep experience in handling agreements with key opinion leaders and specialized stakeholders critical to study oversight and credibility including:

KOL Honoraria Agreements – Structuring fair, transparent, and compliant contracts for advisory boards, protocol input, and scientific consultation.
DSMB / SRC Member Contracts – Establishing clear terms for Data Safety Monitoring Boards (DSMB) and Safety Review Committees (SRC), ensuring independence while defining responsibilities, confidentiality, and compensation.
Endpoint Adjudication Committee Agreements – Setting up endpoint committee contracts that safeguard impartiality, maintain blinding, and align decision-making responsibilities with regulatory expectations.

These specialised contracts require a nuanced approach to avoid conflicts of interest, ensure compliance with anti-bribery/anti-corruption standards, and maintain the independence necessary for credible trial oversight.

Site budget generation and fair market value negotiation

Alongside contracts, budget development and negotiation play a pivotal role in site relationships and trial delivery. At Aixial Group, we use GrantPlan, an industry-standard tool that provides benchmarked Fair Market Value (FMV) ranges for study procedures. This allows us to build budgets that are both transparent and defensible, giving Sponsors confidence and sites reassurance that compensation is equitable.

Protocol-Driven Budgeting – We map every item in the Schedule of Assessments to specific procedures within GrantPlan, ensuring each site budget reflects the real operational effort required.
Coverage Analysis – Our team has extensive experience conducting Medicare Coverage Analyses (MCA) in the US, distinguishing between costs that are Standard of Care (SOC) and those that are research-related. This ensures compliance with federal billing regulations while avoiding disputes with sites during negotiation.
Global Fairness We apply local FMV data, site norms and overheads, and historical metrics to negotiate budgets that are competitive yet sustainable, supporting enrollment and long-term site engagement.
Transparent Negotiation – We work collaboratively with sites to address unique needs (e.g., pharmacy support, imaging, Radiopharmacy handling), while maintaining Sponsor oversight and consistency across the trial footprint.

By integrating GrantPlan data with local knowledge and site feedback, we streamline budget negotiations, reduce cycle times, and build positive sponsor–site partnerships rooted in fairness and trust.

Navigating global data protection requirements

Data privacy has become a central issue in trial contracting. Our team is well-versed in implementing Standard Contractual Clauses (SCCs) and incorporating requirements from GDPR (EU/UK), HIPAA (US), and other national data protection laws.

GDPR & SCCs – Incorporating data transfer safeguards for cross-border collaborations and ensuring sponsor–site data sharing frameworks withstand regulatory scrutiny.
HIPAA & National Laws – Addressing patient privacy obligations in the US, while tailoring contract language for local requirements in Europe, Asia-Pacific, and emerging markets.
Risk Mitigation – Working proactively with sites to align on data handling practices, encryption standards, and data subject rights, reducing the risk of non-compliance later in the trial.

This depth of expertise ensures our Sponsors’ studies are not just legally compliant but also future-proofed against evolving global data protection landscapes.

Case Study: harmonising global contracts in a multi-region oncology trial

One recent oncology trial illustrates the importance of flexibility and expertise in contracting. The Sponsor required activation across sites in the US, UK, France, and Germany — each with its own contracting frameworks, institutional norms, and data protection requirements.

The challenges included:

Diverse Templates – Some US sites preferred to use the Accelerated Clinical Trial Agreement (ACTA), while UK sites mandated the model Clinical Trial Agreement (mCTA). In France, institutions required adherence to national templates, with specific clauses mandated by local authorities.
Data Protection Compliance – With patient data flowing across borders, contracts had to incorporate GDPR-compliant Standard Contractual Clauses (SCCs), while also addressing HIPAA requirements for US sites.
Specialised Committee Contracts – The study protocol required both a Data Safety Monitoring Board (DSMB) and an Endpoint Adjudication Committee, necessitating clear, independent agreements with committee members spanning multiple geographies.

Our Clinical Contract Leads managed this complexity by:

Standardizing Where Possible – We applied consistent sponsor positions across contracts, while adapting to regional templates to avoid unnecessary negotiation delays.
Proactive Data Protection Alignment – We engaged early with sponsor legal teams and site data protection officers to align on GDPR, HIPAA, and national law requirements, ensuring data transfer language was consistent across contracts.
Streamlining Specialized Agreements – Our analysts developed clear, role-specific contracts for DSMB and Endpoint Committee members, ensuring independence while aligning on responsibilities, honoraria, and confidentiality.

The result was a contracting process that met all regional and institutional requirements without delaying site activations. By anticipating challenges and balancing consistency with flexibility, we enabled the Sponsor to launch the trial smoothly and compliantly across multiple jurisdictions.

Lessons learned: contracts as enablers, not barriers

This case study reinforces an important truth: clinical trial contracts are not just administrative hurdles — they are strategic tools that can accelerate or delay study success. Where possible using national frameworks and templates like ACTA in the USA, Convention Unique in France or Clinical Investigation Research Agreement in Australia and many others can streamline negotiations — but only if they are used in line with guidance and Sponsors understand when to adopt standard templates and when to adapt them. This is critical as more and more globally we are seeing the use of national templates and agreed SCCs which require precision and familiarity to avoid protracted discussions. The rise of data protection regulations such as GDPR, HIPAA, and local laws demands early alignment with legal and compliance teams to prevent bottlenecks. Specialised agreements for KOLs, DSMBs, and Endpoint Committees require careful balancing of independence, transparency, and operational clarity.

The common thread across all of these is the need for a team that blends global contracting expertise with local nuance, and regulatory foresight with practical negotiation skills.

At Aixial Group we approach contracts not as a challenge but as a foundation for success. Whether supporting Sponsors through full-service CRO partnerships or providing standalone contracting expertise, our focus is the same: ensuring every agreement is clear, compliant, and built to keep trials moving forward.

Clinical research is fast paced, changeable and often complex so where every patient and every day matters, well-structured agreements create the trust, transparency, and operational efficiency that Sponsors and sites need to succeed.