The role of clinical contract research organizations (CRO’s) has come into focus of late, with the burgeoning growth of the outsourced model for business. In the clinical research industry, CRO’s are considered viable alternatives to expensive domestic players. This is because since it is the clinical study process that needs to be outsourced to developing countries; this can happen at a more economical rate than when insourced to clinical contractors in developed economies.
Pros and cons of managing CRO’s
Undoubtedly, the biggest advantage a pharmaceutical company or any other sponsor gains by outsourcing its clinical research is that it saves humungous amounts of money. This is the most obvious no-brainer, because huge cost advantages exist between developed and developing economies.
In addition, there is also the assurance of quality delivery. A CRO is legally contracted to supply the process and results of a remote clinical trial on time with almost no use of resources from the outsourcing organization.
Of course, there are downsides in managing CRO’s, as there are in any business process. CRO’s that outsource their clinical research need to be in control of the whole process, right from start till finish. Unlike say, manufacturing or software, in which the business deals with nonliving products and technologies; sponsors have to constantly be on their toes in monitoring process, results and quality of their outsourced activity, which can vary with the slightest change in input.
So, what do sponsors need to do for managing CRO’s?
First, the aims and objectives of the clinical research need to be very clearly spelt out. All the steps and processes involved in managing CRO’s need to be mentioned very clearly in writing at the beginning of the outsourcing activity, as any ambiguity at any stage will open the way for interpretation and is likely to lead to unpleasantness
Keeping control over the process remotely is a way of managing CRO’s. In a remote, virtual clinical trial, the integrity of data has to be ensured at all stages and approved, so that the next phase is cleared for starting after the previous one has been validated and approved by the sponsor. Putting these steps in place goes a long way in helping sponsors manage CRO’s effectively.