Sponsors should bring together vendors before a trial begins and have them share information and experiences that will make the project successful, said a consultant at DIA.
External partners, such as contract research organisations (CRO) and other vendors, are now an integral part of trials and increasingly perform roles that until recently were kept in-house. In response to this shift sponsors must treat vendors more like different teams within the same company if trials are to succeed efficiently.
“Vendors have excellent experience”, said Rikki Hansen Bouchard, president and CEO of RH Bouchard & Associates, at DIA 2011. Companies should “tap into this by asking what has worked with other sponsors” and encouraging partners to share non-proprietary information.
Such sharing and collaboration is taking place between leading CROs that are being brought together to discuss development of their common strategic partner's pipeline. While this is an unusual situation for CRO executives, pharma companies, such as Eli Lilly, have spoken of the benefits and this view was echoed by Bouchard at DIA.
“Bring together all the vendors and make them share information that will help the trial succeed. This works very well”, said Bouchard. Face-to-face meetings are best but virtual discussions can also be effective. The main thing is that a meeting takes place and every team has an opportunity to speak.
Reaching an agreement
Meeting helps in-house and external teams understand the trial, their role in it, and communicate their needs. “I've seen situations when some team members were unable to access SOPs (standard operating practices)”, said Regina Freunscht, director, clinical operations, marketing and communications at Accovion GmbH.
Again, the main thing is that everyone knows and can access the relevant SOPs, not whose document is used. “There are very good reasons for letting vendors use their own, or modified versions of their own, SOPs”, said Freunscht. CROs will be used to their in-house SOPs and operations will be set up to follow these processes.