Understanding Bid Defenses in Clinical Trials
It’s important to note that while it seems obvious, a bid defense cannot get underway without providing a good proposal. Therefore, it’s incumbent upon the sponsor to provide a Request for Proposal (RfP) that’s as thorough as possible. It needs to include timelines, draft protocol, project specifications, assumptions, and crucially, key questions for the CRO.
What’s more, the sponsor should be upfront with prospective CROs about the complexity of the trial and how hard it will be to conduct. For the CRO, the bid defense should be an opportunity for the company to demonstrate their credentials. Critically, it’s a chance to introduce their team; sponsors will want to meet and get to know the people they may soon be working with.
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Factors Determining Selection for Bid Defense
When the RfP has been put forward, and proposals from CROs start to come in, there are a number of aspects sponsors will consider before choosing to meet with a prospect:
- The overall expenditure of the CRO’s work
- Whether or not the CRO has put forward the core team expected to work on the trial
- Amount of consideration the CRO has leveled at ensuring the trial’s success
- Alignment of values between that of the sponsor’s and CRO’s
- The CRO’s company standing/status
- Whether the CRO has met the requirements set out in the RfP
Bid Defense – Sponsor/CRO Etiquette
When the bid defense gets underway, the sponsor should make sure key personnel are in attendance. What’s more, the sponsor should be thoroughly prepared, having examined the proposal at length, with questions at the ready. Firstly, the sponsor should put the CRO at ease by being honest and respectful.
The CRO, on the other hand, should ensure the team lead is present in the room; it makes the process much more personal if they’re there to lead the presentation as opposed to participating via telecom. Furthermore, the presentation must be tailored toward the project in question; there’s no point in the CRO touting their global capabilities if the trial is locally-based.
Provide insight into the day-to-day workings of the company, shedding light on what it would be like for the sponsor to work with them. When it comes to site interaction, the CRO should be forthright with the sponsor and explain how easy (or difficult) it would be to enroll patients. At this point, it’s useful to have team members present in the room who will likely spend a majority of the time on the project for their input.
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By GlobalDataFurthermore, CROs should be ready to go through the bid, justifying and backing each point made in the case they’ve put forward. Sponsors will likely quiz the vendor on numerous issues, such as their execution capabilities, project management, site interaction, and clinical monitoring oversight.
Additional talking points include:
- Contract negotiation
- Payment to investigators – How will payments be structured?
- Communication with sponsor – Frequency; How? – In person or over the phone?
- Monitoring plan
- Monitoring reports
Bid Defense – Final Considerations
Ultimately, the bid defense is a process that should be part presentation, but mostly a forum for discussion. The meeting should essentially serve as a microcosm of how a partnership between both parties could unfold. Both sides must be candid and not make promises neither are capable of keeping. At the meeting’s conclusion, draw up a list of action points from the meeting. Offer feedback either at the end of the meeting or after. If after, provide a timeline on when they are likely to hear back from them on a decision. Regardless of the outcome, however, the sponsor must ensure the CRO has a solid understanding on the clinical project as a whole.
*Adapted from ‘Bid Defenses – Considerations and Best Practices,’ Don Kellerman, Zosano Pharma
