Central Lab
Request for Proposal

Selecting a Central Lab is not only a procurement step. It defines how sample collection, lab kit supply, courier setup, sample processing, laboratory data transfer, reconciliation, quality oversight, and inspection readiness will work once the clinical trial is running.

This template gives sponsor teams a structured way to request comparable proposals for Central Lab services, including lab kit production, shipment tracking, sample receipt, sample processing, sample storage, onward shipment, assay validation, method transfer, LIMS setup, portal access, lab data transfer, eCRF reconciliation, reporting, quality management, information security, AI governance, and computerized system validation.

The Central Lab Request for Proposal includes dedicated sections for Central Lab scope, milestones, clinical trial and laboratory design details, recruitment assumptions, Central Lab personnel, laboratory specifications, risk management, lab kits, sample management, logistics, test validation, method transfer, data management, status reporting, SOPs, quality, information security, AI governance, and archiving.

Your team is preparing to outsource Central Lab activities, but the proposal expectations are still scattered across the protocol, laboratory manual assumptions, logistics decisions, data management requirements, and functional input.

You need Central Lab Service Providers to provide comparable proposals, but each Service Provider tends to describe lab setup, kit supply, courier oversight, sample processing, data transfers, systems, timelines, assumptions, and exclusions differently.

You want realistic budgets, but FTE allocation, hourly rates, lab kit costs, courier costs, sample storage fees, shipment assumptions, validation activities, data transfer costs, reconciliation frequency, and subcontractor costs are often difficult to compare.

You need alignment between Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, laboratory specialists, sites, couriers, and external Service Providers, but interfaces are easy to miss unless they are defined before the proposal is requested.

The Central Lab Request for Proposal is a structured, editable Word template for sponsor teams preparing to outsource Central Lab activities for a clinical trial. It is designed to help sponsors define expectations before requesting proposals, collect comparable information from Service Providers, and support a more disciplined selection process.

The template covers clinical trial details, Central Lab milestones, recruitment assumptions, site and participant volumes, laboratory personnel, lab kit production, sample collection and processing, courier setup, shipment tracking, storage, onward shipment, assay validation, method transfer, LIMS and portal requirements, lab data transfer, eCRF reconciliation, operational status reporting, SOP requirements, quality management, information security, AI governance, computerized system validation, documentation transfer, and archiving.