Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may have different priorities and processes when working with external vendors to larger pharmaceutical organizations.
Whereas in a larger pharma company, outsourcing is often the responsibility of a dedicated outsourcing or procurement group, in a smaller company this will tend to fall within the responsibilities of senior management or clinical operations. This can result in faster decision making within a smaller organization so CROs need to be flexible and geared up to respond. In a larger organization, operational and data standards are likely to already be established; in a smaller organization there is the opportunity within the outsourcing relationship to help create those standards.
Very often, there is a need for greater flexibility to respond to dynamic and evolving requests. For the emerging biopharma company the success of the entire business operation may depend on a small number of compounds in clinical trials. This can translate into highly rewarding work for the CRO staff, who may find themselves working with senior executives on highly visible projects which are addressing an area of critical unmet need within the market.
Below, we outline 3 keys to success for those smaller biopharma companies engaging in an outsourcing process.
1) Robust bid process
Taking the right approach at the outset of the bid process is vital. The smaller biopharma company should still have a well-defined CRO selection process including RFP ( Request for Proposal) , and bid defense meeting. Clearly, internal agreement on the important factors you are looking for should be obtained before going out to bid. Approach the CRO relationship with a partnership mindset at the outset, and take note of how the CRO adapts its sales process and pricing to meet your needs as a smaller company. No matter your company size, if the CRO has high staff turnover, it can make delivery challenging, so it’s important to request turnover metrics from your CRO as part of your bid process.
2) Clear communication and transparency
From the outset of the interaction, clear and transparent communication is paramount. A structured approach to communication, which includes regular (weekly/biweekly) teleconferences with operational leaders on both sides can be very helpful and ensures that issues are addressed as they arise.
3) Operational plan
A robust and well-defined governance process should be put in place with a clear outline on how the partnership will be operationalized, including communication plans and escalation pathways.
Cytel regularly supports smaller and emerging pharma and biotech companies with their projects. To read a case study in which we supported one biotech customer on their journey to regulatory approval by providing statistical consulting, data management and statistical reporting services click the button below.