In a recent article at Applied Clinical Trials, they took time to look in depth at the correct way to choose an clinical research outsourcer, and what steps should take place after the correct outsourcer is chosen.
The first step to starting a clinical trial is choosing the outsourcer. Gathering information to choose the outsourcer should be done in three steps. The planning phase happens with the biotech company chooses a CRO. There are two models of CROs a biotech company can choose from: one stop shop or full service (they complete every part of the process) functional outsourcing (establishing functions that the CRO can prepare). Protocol is also written during these stages. Next is the conduct phase. This is where the biotech company collaborates with the study sites and the trial sites have to attract the subjects. Should the conduct phase be operated by the CRO, it is necessary that they recruit the subjects in a timely manner and ensure that there are subjects throughout the trial. During the final evaluation phase, there should be a rapid evolution of study results, due to the processes that were planned an carried out in the conduct phase. Both the sponsor medic and the CRO’s medical writer should be in full cooperation in order to ensure a timely write-up and final report.
When it comes to the selection of the CRO, it is important to correlate the size of the CRO with the study you wish to perform. A smaller, new CRO will focus more attention on the project due to the success and recognition they will receive in the future, but a larger CRO will be able to handle larger test subjects and they could be more skilled to deal with the requests of the biotech companies.
As for the relationship with the CRO, the sponsor must maintain the relationship with the CRO and keep an open path of communication through out the process. It is beneficial for the sponsor to choose a CRO that has already developed a relationship with the investigators. It is also advisable to allow the CRO to work according to their own standards. The CRO must always be held accountable for the success of the study. With that said, it is also vital for the relationship between the biotech sponsor and the CRO to be a full partnership.
A structured communication plan should be documented, and each team should be accountable for upholding the plan throughout the clinical trial. There should also be a document that states the deliverables and the dates for the CRO. The CRO should also ensure that staff turnover does not interrupt the collection of data for the study.
The article concludes with this paragraph on finding success in the clinical study:
Outsourcing a clinical study by a biotech sponsor clearly demands a high level of professionalism and care when choosing the CRO partner. The success of the trial and the biotech–CRO relationship depend on a well thought out protocol and study conduct plan. These truths are more evident when the sponsor is a small biotech taking the large first step into clinical research. The importance of this decision must be reflected in management's commitment to allocate sufficient resources and provide ample support to the sponsor study management. Considerable efforts need to be taken to ensure that the trial is conducted using best practices to ensure its successful outcome.