Vendor Selection & Management Support
With decades of clinical research experience, we can help Sponsors strategically select and manage external vendors across the entire drug development journey. We ensure that every service provider aligns with your study needs, regulatory requirements, and budget, allowing you to focus on advancing your research.
To run a successful clinical trial, you may need multiple external vendors to ensure compliance, efficiency, and data integrity.
Here are the Key Vendors typically involved:
- Central Laboratories
- Imaging & Radiology Core Labs
- Clinical Trial Supply & Logistics Vendors
- Site Management Organizations (SMOs)
- Institutional Review Boards (IRBs) & Ethics Committees (ECs)
- eCOA/ePRO & Wearable Device Vendors
- Translation & Localization Services
- Interactive Response Technologies (IRT) Systems
WEP will streamline vendor selection for seamless clinical execution - this includes the following:
Vendor Identification & Selection
- Identifying suitable vendors based on trial needs (e.g., central labs, imaging providers, data management, logistics)
- Conducting vendor due diligence (capabilities, experience, regulatory compliance)
- Assisting in Requests for Proposals (RFPs) and vendor comparisons
Contract & Budget Negotiation
- Supporting contract negotiations to ensure favorable terms
- Managing service-level agreements (SLAs) to align with trial expectations
- Ensuring cost-effectiveness and budget alignment
Vendor Oversight & Performance Management
- Establishing key performance indicators (KPIs) for vendors
- Conducting regular vendor performance reviews
- Managing risk and ensuring compliance with regulatory guidelines (FDA, EMA, MHRA, etc.)
Communication & Coordination
- Acting as a liaison between the Sponsor and multiple vendors
- Coordinating workflows, timelines, and deliverables
- Ensuring vendors meet project milestones
Regulatory & Quality Assurance Compliance
- Ensuring vendors adhere to GCP, GMP, and other regulatory standards
- Conducting vendor audits to verify compliance
- Addressing any quality or compliance issues that arise
Issue Resolution & Contingency Planning
- Troubleshooting vendor-related problems (e.g., delays, quality issues)
- Implementing contingency plans to prevent disruptions
- Managing escalations and corrective actions
Integration with Clinical Operations
- Aligning vendor activities with clinical trial protocols
- Overseeing data integration and compatibility across different vendors
- Supporting centralized and decentralized trial models