52 Perspectives: “Successful Leadership in Managing Sponsor and CRO Interactions"

Partnerships In Clinical Trials 2011 Media Partner goBalto has teamed up with this blog to bring you weekly perspectives on the clinical trials and outsourcing industry. We are very excited to present you with weekly contributions leading up to next year's event.

52 Perspectives: “Successful Leadership in Managing Sponsor and CRO Interactions

This week’s contribution to ’52 Perspectives’ comes to us from Johan Reinhoudt, the President and Principal Consultant of Collaborative Primacy Life Sciences Consulting. Johan is a practical business visionary with deep industry knowledge through more than two decades of experience in the healthcare and life sciences industries with demonstrated success in global executive leadership roles.

What impact does effective leadership have specifically in the interactions between a sponsor and a CRO?

It is the leadership’s role to clearly defi ne for the organization the information and the details for the Request For Proposal and the subsequent Work Order (contract). It is important that the information be provided in a timely fashion and strategies should not change at mid-course. Otherwise huge costs have to be incurred for “change orders” and delays are highly likely.

Many organizations use the ‘dynamic’ life sciences drug development environment as an excuse to continuously change course, without a clear strategic reasoning. Usually this is more related to the inability to define what needs to be done, than to the necessity to change course based upon recent generated data.

A successful project with a CRO is clearly defined by leadership right from the start. It is also well managed i.e., excellent time, quality, human and fiscal resources and output oversight by both the CRO and the sponsor’s leadership. An outsourced project depends largely upon the specific staff that is allocated by the CR O. When leaders outsource, they factually in-source, they buy a team of resources. To ensure successful completion, the sponsor leader must ensure that the staff within the allocated team are well experienced, knows site and study management and have the right level of communication skills to manage this type of inter-action. In addition, the leader is required to have a clear definition of the contract and pay upon receipt of deliverables (milestones), directed by the project plan.

The leader will require regular operational and seni or management meetings to keep in touch with the CRO organization and ensure on budget and within the projected time frame project completion.

Leaders who successfully manage Sponsor – CRO relationships, understand the collaborative nature, fundamental to a successful outcome. Using a CRO, does not allow for uncontrolled and unprofessional sponsor internal work, to be ‘fixed’ by the CRO. The collaborative partnership established by leadership needs to be modeled after the leader’s behaviors, hence will be visible in the team’s operational approach and project management.

About Collaborative Primacy Life Sciences Consulting:
CPLS Consulting is a specialized management-consulting, leadership and innovation capability development firm, with a primary focus on the biotechnology, medical device and ph armaceutical industry. When business leaders need professional assistance for challenges facing their enterprise, they call on us – a collaborative, responsive and strategic partner focused on their industry and their needs.We strive to be the innovative source of the next generation life sciences consulting, maximizing client value through leadership development. To contact Johan, please Click Here

About goBalto: goBalto is a small team that creates simple, focused and affordable web based software for the global clinical trial industry. Our products offer drug trial sponsors the easiest possible way to start their clinical studies on the web, which makes them feel better. www.gobalto.com