Strategic Clinical Outsourcing (PH125)

Clinical Outsourcing Report Sample

The following excerpt is taken from Chapter 1, "Clinical Outsourcing Strategy" section 1, "Evaluation of Core Clinical Development Capabilities."

Clinical Outsourcing Strategy and Vendor Selection

A major difficulty faced by most teams is disagreement over vendor selection. From a strategic perspective, a CRO's (or other vendor's) size and reach factor directly into project plans. Different stakeholders will advocate niche- or full-service options, and the potential use of different vendors will impact decisions around specific activities. On a broader level, vendor ability to deliver satisfactory results for any given task will impact project management and clinical outsourcing strategy.

Multifunctional involvement in the setting of your clinical outsourcing strategy ultimately aids vendor selection. Involving key stakeholders at an early point helps to align expectations, objectives and processes. In other words, as one sourcing executive put it, working across functions "gets everyone on the same page." Different individuals and groups have the opportunity to share opinions on key tasks, in-house needs and vendor capabilities as the lead team determines what to outsource and to whom they should hand specific activities.

As the process continues, internal familiarity helps to defuse - or at least lessen - inevitable differences and keep clinical outsourcing strategy focused. If stakeholders are used to working together, they are more likely to find common ground when called upon to make project decisions. To one degree or another, shared experience and strategic vision provide a working foundation for all stakeholders.

One strategic path that aids in this process, the use of preferred vendors, can deliver outstanding results - or leave clients with a project's worth of unfulfilled promises. The best ongoing relationships position vendors as external arms of the clinical development group. Over time, they build deep knowledge of client objectives, processes and concerns. That information, combined with strong working relationships forged by constant contact in project after project, positions the vendor to best meet sponsor needs.

When the system works, it eliminates the need for a lengthy vendor-selection process. Better yet, the client knows what to expect and does not have to spend time training the vendor in internal minutiae.

One surveyed company works with only two CROs, and it trusts them to deliver high-quality results on schedule. "All of the projects that we've done with them were on time," says one executive at the company. "They never overpromise, the quality is really good and they do more than most of the others in customer satisfaction."

The following excerpt is taken from Chapter 2, "CRO Selection and Contract Negotiation: Cleaning Up the CRO Selection Process."

While a majority of respondents were happy with the amount of time this process took, Figure 2.22 [data charts appear in complete report] shows that one third felt that it took too long at their company. Many surveyed companies suggest improving the vendor selection process by way of more consistent and transparent costing across vendors. Because each vendor uses different units in calculating overall trial costs, comparing the quality of the quote was very difficult. This becomes especially complex, when companies are considering which changes will likely need to be made to a trial, as each vendor would assess different categories of charges as well as different rates.

Two executives independently suggested requiring CROs to fill out a template provided by the pharmaceutical company along with the CRO's proposal. While some CROs will refuse to provide a quote in any format other than their own proprietary one, smaller CROs may be willing to work with a pharmaceutical company's template. If multiple CROs fill out the same template, then costs can be fairly compared between the CROs' templates.

One criterion that did affect the total proposal process time was whether the CRO was a preferred vendor. Using a preferred vendor saves an average of one to 10 days depending on the phase, as seen in Figure 2.23. The smallest of missteps in the patient recruitment process can cost more time than preferred status saves, but at the same time, every extra day can help in the time-sensitive clinical trial process.