How to prepare a tender specification (RFP/SIWZ) to avoid additional CRO questions and inconsistent bids?
A complete and precise tender specification is critical. It determines how accurately and comparably CRO proposals can be evaluated.
Insufficient detail leads to follow-up questions, extended timelines and large discrepancies between bids. This usually does not reflect CRO competence but rather incomplete or unclear tender documents.
A well-structured RFP should include:
• number of planned sites and participants,
• study phase, intervention type and expected study duration (including recruitment, treatment and follow-up),
• monitoring plan (number of visits, reporting rules),
• pharmacovigilance requirements (expected SAE/SUSAR volume),
• list of operational plans, manuals and deliverables,
• list of documents to be prepared by the CRO vs provided by the sponsor,
• reporting model and project milestones.
It is also essential to indicate whether protocol amendments, system updates, feasibility activities or additional analyses are expected — all of which significantly affect pricing and workload.
Differences in CRO bids typically arise when the RFP lacks clarity about task allocation. If responsibilities are not clearly defined (e.g., site communication, archiving, PV oversight), CROs must make their own assumptions — resulting in inconsistent pricing.
BioStat frequently supports sponsors in drafting complete, transparent tender documentation. This ensures comparable bids, reduces procedural delays and
If you need support in preparing an RFP that ensures comparable offers and saves time for all parties — we are ready to help.
