Nurturing Powerful Vendor/Sponsor Relationships for Trial Success
Thanks to factors like increased regulations, rising costs of conducting clinical trials, competition for patients, and lack of patient participation, clinical research is becoming more and more complex. Most of the smaller companies in pharma and biotech, also known as sponsors, don’t have the workforce, participants, or funds to provide proper oversight of trials. These companies then outsource the oversight of trials to contract research organizations (CROs) and vendors (service providers).
Even though sponsors outsource trial oversight to vendors and CROs, that sponsor is still required to ensure that there is proper oversight of the trial – at the same time, they must oversee the vendors as well. One of the most common problems with this, however, is that many people asked to manage vendors lack the experience to do so – especially when it comes to managing people who don’t directly report to them.
If this sounds all too familiar, you may be looking for ways to improve the vendor-sponsor relationship within clinical trials. Here are five suggestions to help you do exactly that:
- Foster a mutually beneficial relationship to create a “team” mentality
- Know your contract so everyone is held accountable for tasks
- Create clear, realistic trial milestones and timelines
- Establish in writing clear roles and responsibilities for both parties
- Make it clear what is “nice to have” and what is “have to have”
Fostering a Mutually Beneficial Relationship
Many vendor-sponsor relationships are adversarial; the sponsor needs the vendor or CRO to deliver quality and at the same token, the vendor needs the sponsor to clearly direct the project. If the sponsor is not delivering, the vendor needs to escalate the issue to management and clearly state why the vendor isn’t achieving their goals due to the lack of clear, prompt instruction. If the vendor is not delivering, the vendor’s management must be made aware so that it doesn’t happen again. The financial implications of either party not delivering must be made clear. The relationship between sponsor and vendor doesn’t necessarily have to be personal or friendly, but it should be one of professional courtesy.
Knowing Your Contract
The sponsor must be familiar with the details of the vendor’s scope of work (SOW) and the Master Services Agreement, or MSA. It’s vital that contract language is understood in detail so that the sponsor knows the expectations of the vendor before the trial is initiated. In addition, this allows the sponsor to be aware of the consequences of the vendor not meeting contract budgets, payment schedules, and goals. Be sure to reference the contract during the trial as it is warranted – don’t just stuff it in a drawer and never pull it out again.
Creating Clear, Realistic Milestones and Timelines
While setting clear goals is relatively easy, what isn’t as easy is setting realistic ones. If you set a 9-day timeline for a task that generally takes 6-8 weeks, there will be plenty of argument, frustration, and dissonance – and the vendor will miss the goal anyway. You will lose money, time, and generate animosity. The key milestone that sponsors should meet is the First Patient In milestone (FPI). This FPI date is crucial because if it’s achieved within the timeline projected, then stockholders will be confident in the ability of the sponsor company to meet their drug approval timeline.
Establishing Roles and Responsibilities in Writing
This task is a simple one, but very valuable. Use contract language for the sponsor to be able to create a solid list of tasks that are to be done by the vendor. These responsibilities can then be detailed in the vendor’s project plan. Make sure the roles and responsibilities are easily accessible and referenced as often as needed; don’t bury them in an extensive plan that is never looked at once the trial starts. Clearly communicate the duties of the vendor, because every sponsor has different responsibilities for the vendor and sponsor to own.
Distinguishing the “Nice to Haves” from the “Need to Haves”
The keyword here is “priorities” – make sure everyone is aware of the hierarchy of goals and the importance of each of them. This is a time-consuming task, but it will help when timelines become truncated or funding and resources become limited. Be sure the vendor and sponsor know what is absolutely needed for a successful trial; many vendors know their responsibilities very well, but are too often kept in the dark about priorities of the trial.
Sticking to these five guidelines can help manage those outsourced vendors for your clinical trials so you can complete them on time and within your budget. These guidelines focus the vendors on achieving trial goals while providing sponsors with transparent views into where the trial stands in relation to timeline, tasks, and budgets.
Learn more about the vendor/sponsor relationship and other valuable ways to maintain a track record of trial success by attending a clinical trial conference summit in your area.
