By Malorie Meyer, Singota Solutions
Project proposals are among the first steps in the partnership between a pharmaceutical company and a CDMO. The project proposal is critical to defining project scope and goals. Most of the information in the proposal is based on a questionnaire from the CDMO but can also be obtained from a formal Request for Proposal (RFP) generated by the prospective client.
While project proposals can be written to assume unknown factors (given the unknowns associated with working with preclinical/early-phase materials), this can lead to scope creep and delays as revisions or amendments to the project proposal become necessary at different stages of the project (i.e., adding or removing studies). Accordingly, proposal questionnaires are created by CDMOs to provide the details they need to know about a project — not only to determine whether they are able to assist with the project’s requirements, but to empower the CDMO to make appropriate recommendations about how to prevent delays and facilitate smooth project progress.
In an effort to be responsive and remain agile in the face of this uncertainty, Singota continually updates its questionnaire, ensuring it reflects what we need to understand about prospective client needs. Singota is initiating another round of improvements to our process of gathering information about the project and product to be manufactured. Through an improved questionnaire, a checklist of important questions, and in-depth person-to-person discussions with the clients, we conduct pre-proposal gap assessments that aim to identify necessary activities during the project to close the gaps and ensure success.