Key Issues in Choosing a Specialized Clinical Development Partner

Handshake symbolizing partnershipPartnerships drive biopharma development today more than ever, especially in clinical development. The scope of partnerships ranges from contracts to conduct individual studies to functional-service-provider arrangements or outsourcing agreements encompassing whole development programs and sometimes even the whole of a company’s clinical development activity. While clinical development partnerships are commonplace, they are seldom simple. Forming a clinical development partnership requires both parties to consider a host of issues, including but not limited to the following:

  • the capabilities and expertise that each partner brings to the partnership
  • potential conflicts of interest for either party
  • each partner’s level of commitment to common goals
  • the importance of finding a match between company cultures
  • the potential benefits of specialized expertise and early engagement, and
  • the advantages offered by a core therapeutic focus shared between organizations.

A sponsor’s RFP and the proposals submitted by CROs in response typically do a good job of addressing many key issues in selecting a clinical development partner for a specific project. However, this formal exchange of documents tends to answer some questions better than others. For example, it is fairly straightforward to assess organizational capabilities and expertise and to identify potential conflicts of interest. On the other hand, an exchange of formal documents may not be the best way to assess a potential partner’s level of commitment to a project or to evaluate a cultural match between organizations.

Determining Whether a Specialty CRO Is Right for You

The last three areas of consideration on the bulleted list above – cultural fit, the value of specialized expertise in early engagement, and shared therapeutic focus – are particularly important for biopharma companies that are considering a partnership with a specialty CRO. As a CRO specializing in women’s health, Health Decisions and its senior clinical development professionals have extensive experience working on the CRO side of specialized partnerships and in many cases on the sponsor side as well. With this experience comes an understanding of the attributes that are most important to project success. Accordingly, Health Decisions is offering a complimentary webinar to assist biopharma sponsors in considering development partnerships. During the webinar, seasoned clinical development professionals will share insights based on decades of experience in clinical development partnerships. Speakers and their topics will be as follows:

  • Kristen Snipes, Associate Director of Clinical Operations at Health Decisions, will discuss key steps in assessing a match between company cultures.
  • Clint Dart, MS, Health Decisions’ Senior Director, Biostatistics and Programming, will discuss the advantages of initiating an intra-company relationship early, through a regulatory or protocol consultation, before jointly conducting a clinical trial.
  • Health Decisions Head, Clinical Operations, Kevin Bickford, will discuss assessing the benefits of a shared therapeutic focus in areas including access to an appropriate site network, experience working with the target population and understanding of the indication.

The 60-minute webinar will be held Tuesday, June 12, 2018 at 1pm EDT (10am PDT). Complimentary registration is open for all interested in participating.

To discuss your specific clinical development projects with a Health Decisions clinical development professional at BIO this week in Boston, please contact us.

 

2018-06-04T20:56:32+00:00
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