I can't say enough positive things about the recent Outsourcing in Clinical Trials Northeast conference recently held in Framingham, MA.  Arena Events put on a well run conference, with very informative presentations over both days.  From speaking with attendees that were present last year as well, it seems as if participation in the conference, both in attendees as well as corporate sponsors, was almost double from the previous year, so I believe I'm not alone when attributing value to those two days.  It was great to see some familiar faces, as well as to meet some of you in person for the first time! 

On the first day, there was a lot of discussion from the sponsor perspective in regards to vendor staffing and personnel resourcing.  Concerns were expressed about experiencing a bait and switch tactic from vendors by being promised their A team and ultimately being delivered a B team.  Also statements were made from the sponsor perspective in regards to the most disruptive event to happen throughout study conduct, was changes in personnel.  The point was made that in assigning contracts to vendors, in addition to capabilities, a critical decision point is the personnel.  Sponsors are not only selecting CROs/Central Labs for capability but are selecting them based upon the teams of people that are delivering those capabilities. 

While it is discerning to hear from a sponsor that they feel deceived by being promised a specific team, to only find out at contract signing that they are receiving another, I felt compelled to include in my presentation a vendor perspective in response to that sentiment.  After 20 years of working on the vendor side in CRO and Central Labs, I have to believe a vendor will not survive long in this very competitive market, with that type of intentional, deceptive practice of "bait and switch".  The discussion steered towards that phenomena being more likely the result of a lengthy time period between the proposal/bid stage and the actual award/contract signing stage.  It is practically impossible for any viable corporation to operate in modern times with staff that can not be billable for extended lengths of time.  There seemed to be consensus that this was in fact the "root cause" of the issue, as opposed to any intentional desire to mislead. 

To follow up on the train of thought though, I shared with the audience ACM's philosophy on personnel development, which we can always use more of throughout our industry.  A real differentiator of ACM is that we operate on a PM model, where 3 to 4 PMs work in unison, with a Sr. PM (decade or more of experience) leading the team.  This allows a couple of value added benefits;  Redundancy:  by having all members crossed trained on each other's protocols, ACM can ensure that there is always resources available for your protocol, when and where it is needed.  Issue Escalation:  by having a Sr. PM level employee lead each team, every protocol gains the benefit of having an industry experienced expert oversee the timelines/deliverables/costs of each protocol and act as a valuable resource in those instances that issue escalation is required.  Continuous Training/Mentoring:  by having PMs work in a team structure, ACM staff is in a constant state of learning from each other, whether that involves new regions of study placement, new therapeutic areas or new laboratory testing science, whatever happens to one PM on the team, is a shared experience learned from by all.  This is a very efficient and successful method of ensuring that ACM only delivers A team quality personnel to oversee your protocols.

This model, coupled with our industry envied turn over rate of less than 4% per year, is another strong differentiator of ACM amongst our peers.  As so rightly highlighted by the various sponsor representatives at the Outsourcing conference this year, it is much more than assessing capabilities with your Central Laboratory provider, but ensuring that the team assigned to your protocol is qualified, efficient and committed to your goals, as much as you are.

You can download my presentation from the conference here and if you have any follow up comments or questions, please feel free to express them here or contact me directly.  I hope to see you all at the next conference!