Drug Safety
Request for Proposal

Select the Right Drug Safety Service Provider
With a Structured, Inspection-Ready RfP template


A ready-to-use Drug Safety Request for Proposal template for sponsor teams that need clear pharmacovigilance expectations, transparent safety scope, 24/7 coverage requirements, comparable cost input, and objective service provider selection before outsourcing clinical trial safety activities.
For Sponsor Teams Who Need More Than a Generic Pharmacovigilance RfP

Selecting a Drug Safety Service Provider is not only a procurement step. It defines how SAE intake, medical review support, case processing, coding, expedited reporting, reconciliation, safety database use, 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 drug safety services, including 24/7 safety coverage, SAE receipt and follow-up, case triage and tracking, safety database entry, MedDRA and WHODD coding, causality and expectedness workflow support, SUSAR preparation, DSUR support, SAE reconciliation, IDMC safety support, safety line listings, quality governance, information security, AI governance, and computerized system validation.

The Drug Safety Request for Proposal includes dedicated sections for safety scope, safety milestones, safety parameters, safety documents, project governance, regulatory interfaces, medical safety review, case processing, IDMC support, safety database requirements, data exchange, SOPs, quality, information security, AI governance, and archiving.
Do You Recognise This?

Your team is preparing to outsource drug safety activities, but the proposal expectations are still scattered across the protocol, safety management assumptions, internal decisions, and functional input.

You need Drug Safety Service Providers to provide comparable proposals, but each Service Provider tends to describe case handling, medical review, reporting timelines, systems, assumptions, and exclusions differently.
You want realistic budgets, but FTE allocation, hourly rates, case volume assumptions, database costs, reconciliation frequency, 24/7 coverage, expedited reporting support, and subcontractor costs are often difficult to compare.

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

  • User Group
    Clinical Project Managers, Heads of Clinical Operations, Drug Safety Managers, Heads of Drug Safety,
    Clinical Outsourcing Managers
  • Format
    • Drug Safety RfP:
      Microsoft Word
    • Task Allocation List: Microsoft Excel
  • Content
    • Drug Safety Request for Proposal (pre-filled)
    • Task Allocation List (pre-filled)
  • Benefits
    • Clear scope definition before contacting Service Providers
    • More comparable drug safety proposals
    • Stronger documentation of safety outsourcing decisions
The Drug Safety Request for Proposal Template

The Drug Safety Request for Proposal is a structured, editable Word template for sponsor teams preparing to outsource drug safety 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, safety milestones, reporting timelines, participating regions, expected participant numbers, safety documents, governance, risk management, SOP requirements, regulatory interfaces, 24/7 safety coverage, medical safety review, case intake and processing, MedDRA and WHODD coding, SAE reconciliation, IDMC safety support, safety database requirements, data exchange, system validation, quality management, information security, AI governance, documentation transfer, and archiving.
With this Drug Safety Request for Proposal, you will

  • Document which drug safety services and responsibilities are included in your outsourcing process.
  • Start from pre-defined proposal sections for drug safety scope, safety reporting, systems, timelines, and operational requirements.
  • Prioritize the information you need from each Service Provider, including case volume assumptions, FTE allocation, hourly rates, safety database setup, coding, reconciliation, 24/7 coverage, quality, information security, AI governance, and archiving.
  • Align your internal evaluation team on required drug safety information before bid defense, contract negotiation, and award.
  • Create a structured basis for comparing drug safety proposals and documenting your decision-making before selecting a Service Provider.
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