How to get the most out of a CRO’s bid defense
'How to get the most out of a CRO’s bid defense' was originally published by The Pharma Letter. Click here to read the original article.
Bid defenses have traditionally been considered the gold standard for culminating the Contract Research Organization (CRO) selection process. Sitting in a room for an hour or two with the CRO gives sponsors peace-of-mind as they make their final decision. Recently there has been increased chatter regarding the disconnect between the CRO’s Business Development group and the clinical study operations team that occurs post meeting. Drug development companies large and small have been questioning the value of the bid defense – some have been eliminating them altogether, and others are turning to a less conventional method of getting to know the CRO, through a workshop.
Bid defenses can, when executed properly, be extremely valuable. We have some insights to share that we have learned from sitting through years of CRO bid defenses and seeing both the relationships and the conduct of the clinical study play out afterward.
Before a bid defense is held, it is critical that the CRO be required to provide a comprehensive briefing package. The meetings are often short, so the package needs to be requested and reviewed prior to the date of the meeting. In the request, it is important to lay out the topics that you would like covered -- such as the CROs insights on improving study design, input on choices of countries, sites, and a detailed plan for utilizing technology and providing real-time access to trial performance data to support the program’s success. There is valuable information to be gained from an organization that has run similar studies in the past, so you do not want to miss the opportunity to hear it all.
The structure of a bid defense is fairly standard across CROs, and it is common practice for the CRO to begin by spending time walking through their capabilities and statistics. To save time, it is best to review this and other background information ahead of time, as received in the briefing package, and to stick to study-specific topics during the meeting, but the expectations for omitting the “dog and pony show” in the bid defense must be clearly set. By requesting the agenda in advance of the meeting and providing content suggestions, you can steer the conversation toward the study-specific topics that are most critical to your decision-making.
While in the planning stages of the bid defense, it is also important to request that the identified resource who will lead each function attend the meeting. While there is no guarantee that the individuals assigned will not be changed later, meeting with them face-to-face ensures a level of accountability from the CRO on the assignments of their study team and offers the sponsor a chance to interact to elucidate whether each proposed individual’s skills and knowledge are a good fit for the project. Some CROs, if asked, will also provide preparatory packages that include CVs, therapeutic background information, and study related historical metrics if requested. This, along with the conversations that occur at the meeting, will help separate out the experience, cultural fit, and capabilities of one CRO to the next.
Be sure to invite all sponsor study team members to the meeting. It is important that everyone has an opportunity to ask questions of the CRO and voice their opinions. That said, be selective about who from your senior management team is involved. One way to manage your executives is to invite them to an introduction for all parties, and then moving into a more operational discussion with the two study teams. Keeping them involved with regular updates and information is critical, but it may complicate matters or slow things down to have them attend each and every bid defense meeting.
Lastly, it is up to you to help ensure that an open discussion is held on the design and best practices of the sponsor-CRO relationship. If the planning is executed properly, facilitating the discussion can be simple; if left up to its own devices, the meeting can easily be derailed or turn into a waste of everyone’s time.
Although these suggestions may seem commonplace in most corporate meeting settings, they are often forgotten when the CRO selection process is running at full tilt. It is easy to get swept up in letting the CRO take control of the planning and execution of the meeting – especially when multiple bid defenses are occurring during a short period. Even when the best-laid plans are executed flawlessly, they can still be bogged down by certain personalities in the room or relentlessly pursued agenda items.
The limitations of the traditional bid defense meeting have led some companies to believe that the traditional method is not good enough. For them, “tradition” does not lend itself to value. And instead, they are holding in-depth workshop meetings with each potential CRO, and including those individuals proposed to be on the CRO study team, during which they constructively review the protocol and study design and thereby learn just how much the CRO knows about their area of development. They then use this information to help guide the design of their protocol and plan for the clinical trial in addition to selecting the appropriate CRO. This method allows you to see the CRO “in action” and keeps them on their toes. Assessing how CROs perform under stress and on the fly could be critical to finding the best CRO fit.
While there is much to be explored about this new method of CRO selection, I do not yet see the need to abandon all thoughts of tradition. Each clinical trial is so critical to the success of a company, especially in the case of smaller companies, and the penalties of picking the wrong CRO are very high. The traditional model of the CRO bid defense process has been pressure tested for years and has shown that it can, when managed properly, be a valuable experience for the sponsor and eliminate CRO candidates that are a bad match. However, I also urge you to think outside of the box and truly test each CRO during the bid defense process to ensure that the best rise to the top.