What to look for in a trial leader
By: Peter DiBiaso, M.H.A. | February 09, 2016
When it comes to planning and managing the execution of clinical trials, the project manager is like a CEO, leveraging necessary resources and making critical decisions. This is especially true when working with mid-market biopharmaceutical sponsor companies.
These organizations are in a rapid growth phase and typically have a targeted portfolio of assets under development. They are often still building out best practices and standard operating procedures, and frequently rely on their outsourcing providers to fill gaps and share their extensive experience to optimize development success. In doing so, they face the daunting challenge of choosing a provider who not only has the expertise to meet their clinical needs, but also the right cultural fit and ability to perform as a partner who will reliably provide the guidance, knowledge and accountability to help their studies succeed. As part of this assessment, a leading factor for selection is the proposed clinical project manager (CPM). The CPM serves as the true project leader and is ultimately accountable for bringing together all the capabilities and functional expertise required.
When choosing a partner, mid-market organizations should keep the following traits in mind:
Leadership. In the early growth days of the contract research organization (CRO) industry, the primary scope of support was more commonly focused upon transactional services according to sponsor driven specifications. But in the past few years, that model has been turned on its head. Companies today, especially those in the mid-market range, now look to their providers to lead these programs, from start-up through delivery, and to function as a strategic drug development partner who will work with them to achieve success.
Size (sometimes it does matter). A lot of Mid-market companies sometimes shy away from larger global providers because they worry they might not get the kind of close attention and high performing team they will need to succeed. However, if the larger provider has proven mid-market experience, the requisite therapeutic expertise and experienced in-house staff with proven ability to focus on meeting the unique needs of the organization, it can be a great match. Assuming the cultural fit and commitment are in place, mid-market companies can gain added benefits from working with larger providers because they have access to global infrastructure, a vast network of scientific, operational and regulatory experts and scalable talent to quickly meet their changing customer needs, whether the project is run in the US, Europe, Asia or anywhere else in the world.
Patient focus. A good clinical project manager understands the value of the patient to the success of the trial and as such, will balance the needs of the investigator and sponsor, while making sure the patient’s voice is represented in the design, execution and life cycle of the trial.
Teamwork. The best providers will work in tandem with clients, creating cross-functional teams to ensure the project is delivered to the client’s specifications, while also transferring knowledge and best practices that the company can use to support future initiatives. Such collaboration and knowledge-sharing are the cornerstone of an effective strategic partnership.
Accountability. When a mid-market company works with an outside provider to deliver a clinical trial, accountability is everything. That accountability doesn’t just include delivery of specified project goals. It also means adding value for their partners, responding proactively to risks and ensuring all stakeholders are happy with the trial process as well as its outcome. Before agreeing to any relationship, sponsors should ask potential partners to define their delivery accountability, quality goals and processes and to define performance indicators they will use to demonstrate adherence to that plan.
Contingency planning. Projects don’t always go exactly to plan, which means an effective good project manager will have well-articulated contingency strategies in place as part of the overall project plan and long before timelines are at risk. These project leaders should also be quick to update clients when problems arise, open to collaborating on possible solutions and able to draw on lessons learned from past experience to proactively address those issues and drive needed course corrections. The best project leaders continuously anticipate potential problems and think about measures they could take to ensure trial success.
Continuous education. The industry is constantly changing with new best practices, technologies and innovations regularly improving the way clinical trials are conducted. So when choosing a partner, you should look for a company that insists on continuous education for its project managers and their teams. That may include formal training programs, mentoring opportunities and established project management centers of excellence where team leaders are constantly enhancing their skills to better support current and future clients while promoting career development growth.
A good project manager will make or break a clinical trial. With fewer development assets compared to large biopharmas, mid-market companies should take care in choosing the right partner with the best talent and processes to ensure you will have the support and expertise you need to deliver your critical trials successfully.