Site Set-Up & Contracting
Effective site setup is critical for ensuring a clinical trial runs smoothly, on time, and within budget. Delays in site activation can significantly impact patient recruitment, trial timelines, and overall costs. Our expert team streamlines the entire process, ensuring sites are fully operational, compliant, and ready to enroll patients, on time and within budget.
A Clinical Trial is Only as Strong as its Sites
Your clinical research sites will be the foundation of your clinical trial. Expertly managing sites is our bread and butter at WEP – just ask any one of our Sponsors. We will provide:
- Global site network & investigator relationships
- Proven track record of reducing site activation timelines
- Regulatory expertise across multiple markets
- Cost-effective and transparent contract negotiation
- Seamless technology integration for efficient site management
- Drafting & Negotiating Clinical Trial Agreements (CTAs)
WEP will support Sponsors with the following:
Site Qualification & Activation
Once sites are selected, WEP will conduct a Site Qualification Visit (SQV) to confirm that:
- The site has the necessary facilities, staff, and technology.
- The Principal Investigator (PI) is adequately trained.
- The site can comply with protocol requirements, patient follow-up, and data reporting.
Following approval, sites move to the activation phase, which includes:
- Site Initiation Visits (SIVs)
- Regulatory submissions
- Investigator training
- Finalizing contracting & budgeting
Contract Negotiation & Budgeting
WEP manages the negotiation of Clinical Trial Agreements (CTAs) and site budgets. This involves:
A. Site Contract Negotiations
- Negotiate CTAs between the Sponsor and research sites, ensuring:
- Compliance with local laws and regulatory requirements (e.g., GDPR, HIPAA)
- Clearly defined roles and responsibilities of all parties
- Proper indemnification and liability coverage
- Data privacy and ownership rights
- Key Challenge: Different countries and institutions have varying legal and ethical requirements, leading to prolonged contract negotiations. WEP uses standardized contract templates and leverages local regulatory expertise to accelerate this process.
B. Budget Negotiations
- WEP helps Sponsors develop and negotiate site budgets, considering:
- Investigator fees, site overhead, and staff salaries
- Patient visit reimbursements, diagnostics, and procedures
- Trial-related costs (e.g., pharmacy, imaging, data collection)
- WEP uses benchmarking tools to ensure fair compensation while maintaining cost control for Sponsors.
Outcome: A finalized contract and budget that aligns with trial timelines and regulatory expectations.
Ethics & Regulatory Approvals
WEP manages the submission and approval process with:
- Institutional Review Boards (IRBs) / Ethics Committees (ECs) – Ensuring informed con-sent materials and study protocols are ethically sound.
- Regulatory Authorities (FDA, EMA, MHRA, etc.) – Securing necessary approvals before trial initiation.
- Data Privacy Compliance – Ensuring adherence to GDPR (Europe), HIPAA (US), and other data protection laws.
WEP will also handle documentation and compliance tracking, ensuring that all required approvals are in place before patient enrollment.
Site Training & Initiation
Once contracts and approvals are finalized, WEP will:
- Provide comprehensive training programs to prepare site personnel, including Principal Investigators (PIs), study coordinators, nurses, and clinical staff, for their roles in the study.
- Provide protocol-specific training for studies that involve specialized procedures or complex interventions
- Provide eClinical Technology & System Training
- Implement site monitoring plans to ensure regulatory compliance.
- Establish communication channels ongoing training and issue escalation and resolution.