Organizational Design For Clinical Development Organizations

As technology and the pressures of the COVID-19 pandemic have reshaped the way in which clinical trials are conducted, emerging and mid-size life science organizations are under unique pressures to operate dynamically and more nimbly than ever before. The pandemic has redefined long-established clinical research processes and clinical development organizations are discovering the impacts: accelerated approval deadlines, expedited development timelines, and business imperatives demanding greater efficiencies from a shrinking talent management market. In the past three years, organizations have has to respond to these rapidly evolving research and development (R&D) needs by reexamining and devising new ways of working, such as building scale programs and accelerating adoption of digital mechanisms.

Organizational leaders and clinical operations teams are challenged to balance the need for increased productivity with assured quality outcomes for clinical trial operations. To do so, many organizations are exploring more agile approaches in traditionally complex matrix structures at their clinical development organizations (CDOs).

As it appears unlikely clinical development processes will revert to pre-pandemic “norms,” CDOs are ardently pursuing efforts to expand what’s possible. This pursuit means organizational leaders must understand the key factors redefining CDOs and the steps they must implement to drive value in the short term, as well as address the critical need to drive greater efficiencies amidst an industry-wide war for clinical research talent.