Most early-stage biotechnology companies have limited resources and manpower. As a result, early-stage biotechs conducting randomized clinical trial research often need a CRO’s help to deliver the quality data required to make their ideas and theories achieve practical purpose. In addition, engaging a CRO with a depth of strategic expertise early in the planning process can provide sponsors with additional knowledge when building out an effective operational program.
Building a partnership of trust between the biotech’s internal team and its CRO of choice is essential. Here are five places to begin:
- Consider consulting a select number of competing CROs in the RFP development process.
This will allow for both the biotech team and any potential CRO partner(s) to better feel each other out and develop clear expectations of what is expected from the very start. Plus, CROs will likely be able to offer more customized solutions to the biotech’s specific needs its limited staff may not have considered. Involving the CRO early in the process shows that you’re looking for a trusted partner, not just a supplier. Also, you will likely end up with a much more accurate and financially workable CRO agreement than would otherwise result. - Make sure the CRO has a successful track record working with small biotechs.
There are more than a thousand CROs in the world. Not all CROs are created equal or can meet the needs of small biotechs. The lowest bid price is not everything. What have the CROs you’re considering done with other small biotechs? How have the CROs mitigated or eliminated risks specific to small biotechs? A CRO without such a track record could end up costing a lot more in the long run. Ask for a client reference list. - Make sure a proper oversight process is in place.
There are disagreements in any relationship, no matter how strong. Stuff happens. Make sure that any signed agreement between the sponsoring biotech and the CRO(s) includes clear instruction on how the relationship will be policed, and at what cost to whom. If not, the trust you worked so hard to build may unnecessarily erode. Think of it as a prenuptial. No one wants a relationship to end when it begins, but circumstances do change. Setting expectations and processes at the start can save lots of grief and money in the end. - Research management and employee stability at the CRO.
Building an integrated project team, not just a transaction-based one, requires management and employee stability on both the biotech and CRO side of any partnership. Research the turnover of the CROs you are considering. If the key team members are not the same ones who were with a project at the start, and the team lineup constantly changes, then trust will eventually erode, too. Make sure you understand who the people are you will be working on specific project teams and what succession plans exist if a key person were to leave. - Painstakingly pick your CRO project teams.
Always keep in mind that the CRO you select will be an extension of your team. It is not just about the CRO, but the people it employs. The CRO industry of today has many of biopharmaceutical industry’s best and brightest working in its ranks. Still, there is more to building trust than someone’s expertise. The personality makeup of any team matters, too. Any integrated project teams and the management of the sponsoring biotech and the CRO must be able to work together, and more importantly trust each other.
Additional Resources:
[White Paper] Pharma Quality Agreements: What Are They, and Why They Matter For Your Study
[White Paper] ICH GCP E6 (R2): A Primer for Small Biotech and Specialty Pharma Companies