Expected Changes to the Vendor Landscape in 2018

Expected Changes to the Vendor Landscape in 2018′ was originally published by Applied Clinical Trials. Click here to read the original article.

Over the last several decades, contract research organizations (CROs) have become heavily involved in the conduct of clinical trials. Sponsor companies often saw the involvement of CROs as an opportunity to alleviate burdens on their internal teams and staffing, to reduce risk by not investing in full-time employees, and to gain targeted knowledge related to disease areas, trial designs, geographies, and clinical sites. In situations where CROs have acted as true operational and strategic partners with the sponsor, these benefits have usually been realized.

However, the reality is more common that relationships between sponsors and CROs are not seamless, and outsourcing to a CRO ends up causing a different slew of complications for the sponsor. These can include duplication of effort, increased decision-making time, failure to identify important issues of trial design or execution, frustrations associated with the management of the high rates of turnover of study staff, and other administrative stressors like contracts and payments associated with any vendor.

Because of this, some of the most “innovative” companies are rethinking their outsourcing models. They are bringing certain functions back in-house and reducing the amount of work out-sourced throughout all phases of clinical trials, from conception to completion.

Recently at an executive retreat, we held a workshop and except for a couple of very large pharmaceutical companies who already conduct their clinical development programs completely in-house, attendees from every other size company were in agreement that if they could, they would shift away from outsourcing their work. The two biggest areas of focus during the discussion that followed pinpointing specific areas of dismay are monitoring and project management of the trials.

In companies of all sizes, managing and overseeing outsourced projects involves dozens of both parallel and sequential activities with significant redundancy between the sponsor and the vendor. There are a million ways things can go wrong, and most sponsor PMs feel a sense of ownership that can never be matched by a vendor who has multiple projects of their own to manage.
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