Request for Proposal Template Clinical Trial

REQUEST FOR PROPOSAL (RFP): CLINICAL TRIAL SERVICES

DOCUMENT CONTROL

• Document ID: RFP-CT-202X-001
• Effective Date: [Date]
• Version: 1.0
• Jurisdiction/Scope: [State/Country Laws] / [Specific Study Protocol ID]

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1. OFFICIAL NOTICE AND LEGAL DISCLAIMER

This Request for Proposal ("RFP") is issued by [Company Name] ("Sponsor") for informational purposes only. This document does not constitute a binding contract or an offer to contract. Submission of a proposal does not obligate the Sponsor to enter into an agreement. All intellectual property, clinical data, and proprietary methodologies disclosed herein remain the exclusive property of the Sponsor. Recipients must maintain strict confidentiality regarding the contents of this RFP.

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2. PARTIES & DEFINITIONS

• Sponsor: [Full Legal Name of Sponsor], having its principal place of business at [Address].
• Contract Research Organization (CRO): [Full Legal Name of Respondent], having its principal place of business at [Address].
• Study Protocol: The clinical investigation titled "[Full Protocol Title]," identified by [Protocol Number].
• Effective Date: This RFP is open for response until [Submission Deadline Date].

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3. OPERATIVE CLAUSES & OPERATIONAL REQUIREMENTS

3.1 Scope of Services

The selected CRO shall provide comprehensive clinical research services, including but not limited to: site selection/activation, patient recruitment, clinical monitoring, data management, pharmacovigilance, statistical analysis, and regulatory submission support in compliance with ICH-GCP guidelines.

3.2 Compliance and Regulatory Standards

The CRO must attest to current compliance with:

1. FDA 21 CFR Part 11 (Electronic Records/Signatures).
2. GDPR/HIPAA compliance regarding Protected Health Information (PHI).
3. ICH Good Clinical Practice (GCP) E6(R2).

3.3 Financial Proposals

Proposals must include a detailed line-item budget including:

• Pass-through costs (IRB fees, site payments, travel).
• Fixed-fee milestones linked to study deliverables.
• Contingency/Change Order protocols for protocol amendments.
• Total Estimated Budget: [Amount in USD/Local Currency].

3.4 Data Ownership and Confidentiality

All raw data, case report forms (CRFs), and study results generated under this project shall be the sole property of the Sponsor. The CRO shall execute a separate Non-Disclosure Agreement (NDA) as a condition of proposal acceptance.

3.5 Term and Termination

This engagement, upon execution of a Master Services Agreement (MSA), shall commence on [Start Date] and continue through [Completion Date/Study Closeout]. The Sponsor reserves the right to terminate for convenience upon [Number] days’ written notice.

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4. EXECUTION & SIGNATURE BLOCK

IN WITNESS WHEREOF, the authorized representatives of the parties have caused this RFP acknowledgement to be executed.

For Sponsor: Signature: __________________________ Printed Name: [Name] Title: [Title] Date: [Date]

For CRO (Respondent): Signature: __________________________ Printed Name: [Name] Title: [Title] Date: [Date]

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5. STEP-BY-STEP EXECUTION GUIDE

1. Drafting: Fill all bracketed [...] fields with precise project parameters. Ensure the "Study Protocol" reference matches the internal Clinical Trial Protocol (CTP) version.
2. Confidentiality: Distribute the RFP only after the CRO has signed an overarching Mutual NDA. Do not circulate sensitive proprietary study protocols until the NDA is fully executed.
3. Submission: Require submission in PDF format via encrypted transmission. Include a "Required Attachments" checklist (e.g., CRO SOP index, Quality Assurance certifications, CVs of lead clinical personnel).
4. Review: Establish a selection committee comprising Clinical Operations, Legal, and Finance leads. Use a weighted scoring matrix (e.g., 40% Technical/Site Network, 30% Compliance/Quality, 30% Cost).
5. Finalization: The RFP response serves as an Exhibit to the subsequent Master Services Agreement (MSA). Ensure the final contract contains a "Precedence Clause" stating that the MSA terms override the RFP proposal in the event of a conflict.
6. Filing: Archive the original signed RFP response and accompanying correspondence for a minimum of 15 years post-study completion to satisfy regulatory audit requirements.