By Tim Krupa, president, TSK Clinical Development
Increasing clinical trial costs and lengthening drug development timelines compel the biopharma industry to increase its outsourcing of clinical trials. While such outsourcing is generally successful, often the biopharma sponsor feels the experience could be better. Our challenge is improving the effectiveness of outsourced trials while achieving greater satisfaction for all parties. To improve clinical trial outsourcing, biopharma sponsors should focus on two often overlooked processes: the corporate outsourcing strategy and team building.
Biopharma Outsourcing Strategy
A biopharma outsourcing strategy clearly delineates the outsourcing expectations to all stakeholders. This strategy begins with a clear understanding of the core competencies to be retained by the biopharma sponsor and the functions to be outsourced. All stakeholders must agree to the expectations of the external partners for both the current and future pipeline. Such agreement is a key to success.
All sponsor stakeholders also must agree to the nature of the outsourcing relationship. Is the intent to simply outsource certain activities? Is the intent to maximize the ROI of the biopharma development dollar? If so, then the biopharma company may only be looking for a “pair of hands,” albeit experienced and cost-effective hands.
If, however, the corporate outsourcing strategy seeks a development partner(s) committed to deliver value through experience and expertise, then the outsourcing choice is viewed as a long-term decision. In such partnering, the biopharma sponsor is looking for greater commitment, seeking to engage the CRO’s “brain.”
And, if the corporate outsourcing strategy seeks a truly engaged development partner(s), the strategy should seek to form a much more interdependent longterm relationship. In this type of relationship, the biopharma sponsor seeks to engage the CRO’s “heart.”
The successful outsourcing relationship should include a governance structure to oversee all activities. To create a “pair of hands,” the immediate line management of the participating companies should suffice. If, however, the biopharma sponsor wishes to create a long-term relationship gaining the “hearts and minds” of its outsourcing partner, a steering committee of executives from each partner is formed and meets at least quarterly to set strategy, resolve issues, and oversee operations.
Treat Team-Building As Imperative
All too frequently, outsourcing efforts begin with the contract award. An initial team meeting is called, introductions are made, and the clinical trial begins. This is a big mistake!
Both the sponsor and provider bring experience and expertise to the relationship, and in an effective collaboration, best practices result when the knowledge, skills, and expertise of each team member are used to meet the needs of all stakeholders. Every project should begin with a face-to-face kickoff meeting. No exceptions! The primary purpose of this kickoff meeting is to begin building relationships, learning what each member brings to the team. Funding is always tight; resist every effort to view this as an opportunity for cost savings. This meeting is essential to successful outsourcing. The meeting should last one or two days depending on the complexity of the clinical program and the previous relationships of the participants. Key team members from sponsor and provider(s) should attend. Consider an informal event the evening before as conducive to building relationships. Also, have each team member at the kickoff meeting introduce a member of the other company during team introductions.
The kickoff meeting is generally held at the sponsor’s offices, where all team members must make the meeting their sole focus. The phones of all participants should be turned off. In addition, discourage the biopharma team from returning to their desks to attend to business. Instead, use lunch and breaks as relationship- building opportunities. As time allows, incorporate team-building exercises into discussions of scope of work, roles and responsibilities, timelines, and deliverables. Nothing replaces face-to-face encounters when it comes to building personal relationships. Successful outsourcing requires good relationships of fully engaged teams.
If the goal is improving the effectiveness of outsourced clinical trials, a collaborative environment based on trust, mutual respect, and commitment to execution requires, and can best be achieved through, a conscious biopharma sponsor strategy and teamwork. In the words of Michigan’s famous football coach Bo Schembechler, “It’s the team … The Team …THE TEAM.”