The People Factor

28th July 2016 (Last Updated July 18th, 2018 09:19)

Andrew Taylor explores the importance of matching your trial requirements with the right people

The People Factor

When entering into a relationship with a service provider, there are some key areas you must consider. The service provider must be able to do just this, provide the necessary services to the sponsor company by accurately fitting into an original RFP (Request for Proposal). But whilst these factors are crucial, a key area where both the sponsor and service provider must share common ground is the importance of intra-personal relationships related to the trials. Often the success of a trial can boil down to personal relationships, and it is within this area that both parties must find a strong link.

A People Partnership

The performance of clinical trials can often boil down to human factors. Naturally, building up good relationships with the provider you are working with can often be the main factor determining whether your trial runs smoothly or not. Alternatively, if you are finding it hard to build a relationship with the project manager or the CRA, you may struggle to have a motivated team overseeing your study. No matter the working environment or situation, put simply, people want to do well for those they admire or work well with, not for those they don’t. And if good relationships can be found there are also longer term benefits. If a particular trial ran to timelines, and there was a generally good experience with your CRO, you should anticipate an extended partnership, which may stretch across multiple trials. Not only will you be working with those you have worked well with previously, but ultimately your will be saving yourself time and in turn money. Nevertheless,  perfect CRO and Sponsor relationships will not always lead to a perfect trial record, as key requirements for the study may still not be met, and timelines may still be missed due to external factors. However, a strong partnership serves as a sturdy foundation for clinical trials, without which could get your project off to a shaky start.

Meeting the Team

In order to get your dream team, be sure to meet with them in person before the trial begins.  Sounds simple enough, however, many sponsors can begin their trials without actually meeting their service provider colleagues until the first day. The best place to become introduced is in initial bidding meetings; not only will the service provider have to win you over with their capabilities, but they will also have to show they are people you could see yourself working alongside on a daily basis. Often sponsors will be introduced to directors in the pitch, who have the knowledge, but when the day of the trial comes, they end up working with their junior colleagues. Unsurprisingly, this often causes unexpected difficulties within the trial, so ask the questions to make sure you can actually meet the team you are working with before operations begin. Arguably niche CROs may not suffer from this ‘backroom staff’ problem, as their specialised team, which will brought along to the bidding meeting, will often be the same team you work with in the trials. On the other hand, it remains crucial that you visualise  yourself  working alongside them; if not, chances are  they probably aren’t the right CRO for you.

Turnover Difficulties

Many successful relationships in the clinical trial world are formed through when both parties are able to meet with each other before the trials begin. However one factor can scupper a perfectly good working partnership; staff turnover. A factor which plagues some CROs more than other, you may find your blissful partnership with the original CRO team can completely change 6 months down the line. In this regards, there are only so many options for a sponsor to take, other than knuckling down an trying to proceed with a ‘business as usual approach’. Inevitably, people assigned as replacements will take up time as new processes must be put in place to help get operations back to their original state. However there are measures which can help avoid this situation arising. Before selecting your CRO, make sure to gather feedback from others in the industry. People who have worked with them in the past can not only offer you an insider’s perspective on the CRO’s working, but also give you helpful answers to key questions such as turnover rates. So, when choosing a new partner, make sure to consider their turnover rate.

 

When considering a CRO partner, key elements should form a part of your decisions. Their capabilities, resources and track record are definitely good measures of their likely future performances. However, an element that is often overlooked, or perhaps never considered at all, is the inter-personal relationships between those on the sponsor and CRO parties. Good relationships will lead to good relationships throughout operations; a fundamental for clinical trial success.