Morula Health’s innovative Medical Writing strategy to help reduce start-up and improve CRO selection process.
Current Process / Challenges
Biotech companies adopting a full-service or hybrid outsourcing model sometimes include the writing of core clinical trial documentation as part of the Request for Proposal (RFP) scope of services. It means the writing of these documents cannot start until a Clinical Research Organisation (CRO) is chosen and a contract signed. This impacts study start-up timelines; the finalization of these documents becomes the rate limiting step as many activities cannot be completed until these documents are finalized.
An RFP provided to a CRO sometimes consists of only a basic study outline, ideal study timelines and scope of services. CROs use this information to define their strategy, conduct a high-level feasibility assessment, and estimate the cost of services. With only a basic study outline, CROs are required to make assumptions. The result can be proposals with variability in strategy and costs, and require multiple revisions throughout the process – making an already hard decision even harder.
Whilst we acknowledge this approach is often out of necessity for resource-constrained biotech companies, the impact can be significant. Fast study start-up can be the difference between reaching or missing First Patient In milestones, often a key milestone for funding/ licensing agreements. Selecting the right CRO can be the difference between the success and failure of your study and in some cases the whole company.
Start your RFP process with a final/near final protocol, ideally one that has been reviewed by patients, KOLs, and regulators. Whilst the RFP process is ongoing, either internally or with a medical writing service provider, start finalizing the core clinical trial documents. This enables study start-up to occur without delay upon contract signature with the chosen CRO.
The final/near final protocol standardizes many assumptions, allowing CROs to focus on the strategy to deliver your study successfully and reduce the risk of costly changes shortly after CRO selection.
Assessments defined as outside the standard of care can increase regulatory approval timelines in some countries. A finalized schedule of assessments avoids selecting these countries during the proposal process, instead CROs focus on countries with the shortest approval times and highest recruiting sites that align with your objectives and study design. The countries for a clinical trial determine the CRO selected for a clinical trial, it can be costly to find out after CRO selection that a CRO has minimal experience or requires partners in a selected country because the strategy needs to change.