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Sponsors understand the importance of selecting the best Contract Research Organization (CRO) or niche service provider for their strategic product development. To do so, sponsors need to invest in making an informed decision. The way to do that is to map out your process.
Sponsors that understand the process and practice strategic sourcing, typically plan better, and this reduces future challenges. Creating documentation that communicates your procurement needs allows for a best fit outsourcing approach. This checklist provides an example of the materials to be created by the sponsor as well as those to be received from bidders.
This underscores the importance of having an electronic trial master file that is populated with comprehensive program materials that start with CRO selection and are available at all times.
1. RFP sent to qualified CROs/Niche Vendor
2. RFP Questions received from bidders and Question/Answer document provided anonymously to bidders
3. RFPs received
4. Proposal Scorecard finalized
5. RFPs scored
6. RFP finalists invited for bid defense
7. RFP scoring finalized
8. Top CRO/Niche vendor notified of win and requested a final scope and detailed budget
9. Top CRO contract negotiations
CRO Selection Checklist
AN EXAMPLE WORKFLOW:
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Bidders should know what is important to your organization and sponsors who are ready to make a large investment in outsourced services want to assess service providers viability to minimize risk.
RFP CHECKLIST
CRO/Niche Vendor Request for Information (RFI) Prequalification Checklist
Corporate overview/ Organizational chart/Office locations and services at each site
Financial stability
Insurance
Compliance with business ethics/privacy
Facilities and Computer
Management Systems
Quality Management
Systems (including documentation management)
Human Resources and Training
Project Management (including SOPs and thirdparty vendor management)
Specialty services (EDC, lab, imaging, interactive technologies, etc.)
If the RFI/prequalification was not performed, some of this information should be requested in the RFP documentation and contracting can be contingent upon receipt of these due diligence elements.
As you consider what you need from CROs/Niche vendors, this checklist will minimize questions and allow for thoughtful responses.
Program Background
Proposal Guidelines/Deadlines and forms (include ‘Intent to Respond’ form)
(continued)
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Checklist originally provided by NeoTrials, LLC.
RFPs can also contain information about the expected type of contracting the Sponsor intends to utilize in this award. Since clinical trials can be highly variable, most CROs push for Time and Materials (T&M) or unit pricing contracts, but the goal for any sponsor should be optimum value with minimum risk.
T&M contracts bear the highest risk for sponsors (risk for overruns), so other contracting vehicles/approaches or a hybrid approach (milestone-based contracts) may allow for risk sharing between parties.
Proposal Deliverables
Protocol/Protocol synopsis
Program/Project Timelines/Milestones/ Assumptions Roles and Responsibilities
Technical Specifications for each area of service (i.e. detailed tasks for project management (PM), Clinical Operations, data management (DM), Biostatistics, Pharmacovigilance, …) and the proposed team (including cvs) and vendors/third party subcontractors proposed
Specialty experience or past performance requested/required (unique qualifiers)
Important details, challenges identified by sponsor team and CRO recommendations
Simple budget template (high level to be able to compare without increasing CRO burden)
Evaluation Criteria (financial and technical)
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