Subscribe Become an Author Sign Up Log In

Choosing The Right CRO For Pharma R&D Outsourcing

   by Henk Johan Streefkerk, Contributor    223    Comments 0

Disclaimer: All opinions expressed by Contributors are their own and do not represent those of their employers, or BiopharmaTrend.com.
Contributors are fully responsible for assuring they own any required copyright for any content they submit to BiopharmaTrend.com. This website and its owners shall not be liable for neither information and content submitted for publication by Contributors, nor its accuracy.

This post was originally published on Quora, answering the question: "How do drug manufacturers select the right contract research organization(CRO)?"

Selecting the right contract research organization (CRO ) obviously depends on what activity is outsourced and with which regulations the outsourced processes need to comply. However, the following criteria certainly apply to pharma companies.

Typically, we would request evidence on how often the CRO has performed the activity, i.e., what their relevant experience is from a technical operation point of view. However, it is also very important to understand how they deal with Quality Assurance, Training, Disasters, and if they have been inspected by health authorities before, if upon inspection there were any critical findings, and how they managed these findings.

Next, we would look at their systems, if they are validated, how the disaster recovery is planned for, how the support is arranged, how frequently their systems are updated, what the process is for updating, and what the backup systems look like. Using the newest systems may be an advantage, but might also just be a sales pitch. Having a huge experience with a trusted but slightly older system might be even better than having little experience with the latest and greatest system with all the bells and whistles that blow nobody any good.

And last but not least, we would request the CRO's project team to present their pitch to us live, to evaluate all of the above, but also how the CRO's team is integrated and performs. We would assume that the CRO would send out their "best" team, and if their best team is unable to perform during a pitch (i.e., provide satisfactory answers to our most complex questions and disaster scenarios), it is unlikely that they will perform when there is a real issue at hand. So, team integration and team performance are extremely important as well.

Based on all the above, we would be reviewing how to keep oversight of this vendor. If we would not have confidence that keeping oversight is at least feasible, we would skip this vendor. When inviting several CROs, the best CRO will become clear to us pretty soon.

 

Disclaimer: I wrote the answer from a personal point of view, and not on behalf of my current company.

Share this:              

You may also be interested to read:

 

Comments:

There are no comments yet. You can be the first.

Leave a Reply

Your email address will not be published. Required fields are marked *