PROJECT MANAGEMENT

Rodi Connects offers project management during various stages of product development. From the R&D phase to commercial manufacturing, Rodi Connects can carefully manage all aspects of relationship with CMO/CRO’s, this may include contract negotiation, (technical) support, and relevant quality documentation (e.g. batch production records (BPRs)) and reporting to agreed timelines.

Rodi Connects provides experience with an extensive network of CMOs and CROs to identify potential CMOs which can deliver the required technical know-how, technology and quality, and evaluate proposals independently and objectively on a case-by-case basis.

In case of selection of a Contract Manufacturing Organization and of a Contract Research Organizations, it is an important decision which is often made early in CMC development and early in the drug development program. The associated request for proposal (RFP/RFQ) process and contract negotiations (including quality and price) require significant resources, skills and experience.

CMO selection is often binding beyond the direct contractual and financial details, e.g. it may not be technically feasible to move manufacturing during development without negating nonclinical and clinical study data or necessitating bridging studies. Regardless of the compound, it is costly to change CMOs. Therefore a first-time-right approach is crucial.

The decision matrix for the selection of a CRO requires careful definition of the service required and identification of associated critical factors e.g. cost, technology, quality, logistics and time-lines. In the case of niche service providers or service providers with exclusive use of proprietary technologies, the options may be limited and require a proactive approach to ensure a successful collaboration. A single CRO may not be skilled in development, validation and routine analysis (in a suitable good practice quality environment). Analytical methods are often developed and validated before being transferred to a different CRO (or CMO) for routine analysis. This complex process requires management of the CROs and experience of the practical aspects of technology transfer.