Untying the Outsourcing Knot - Pharmaceutical Executive


Untying the Outsourcing Knot
Outsourcing promises to be a major strategy for pharma in the years to come. But too often, it doesn't work the way it should. To get an expert's view, Pharm Exec talked with industry veteran Jon Koch, vice president of clinical operations, Americas, for Charles River Laboratories about the problems companies most often encounter when working with CROs. Here, Koch illuminates the top five—and provides some suggestions for sponsor companies to help keep their CRO relationships on track.

Pharmaceutical Executive

From the sponsor perspective, a handful of metrics are particularly important: timeline, action completion and follow-up, scope control, budget management, and turnover. In addition, depending on the scope of the study, site and patient enrollment may also be key. Increasingly companies are creating "dashboards" to give executives a quick overview of what is going well and what is not.

Escalation Failure As problems emerge, team members need to bring them up through the hierarchy to the proper level so they can be resolved. But survey participants said that often didn't happen. Sometimes issues languished to the point of jeopardizing critical path activities. Other times, teams struggled to identify parties who were empowered to make decisions on scope of work, quality, or risk/benefit ratios.

It is crucial to have a highly defined escalation path naming specific points of contact and their authority to resolve various sorts of problems. Once the areas of concern have been identified, the paths mapped, and the whole plan agreed upon, it is important to test it before the study, making sure that people are aware that they're part of the path and understand their responsibility in it. Again, higher-level executives need to understand and support the plan in advance.

Loss of Lessons Learned Clinical research organizations today handle hundreds or thousands of trials at a time. And in a rapidly changing environment, they frequently learn valuable lessons, either about things that went wonderfully and can possibly be replicated elsewhere, or about things that went badly and should be avoided in the future. But often at the end of studies, sponsors and providers are both so geared to moving on to the next step that they skip the process of looking at what went right and what went wrong. When that happens, lessons are lost—mistakes are repeated across projects, providers, and sponsors; and experience becomes dependent on people rather than becoming institutional.

Solutions include:

  • Enforce the need for documentation
  • Instill openness and collaborative resolution from the start
  • Periodically survey the team for clear examples of what is and isn't working
  • Review collective materials at study conclusion and take appropriate actions.

Because so many lessons get lost at the ends of projects, it might be useful to build in a capture mechanism earlier in the cycle. Some pharmaceutical companies use a midway review. They select a point halfway through the study and have a formal dialogue between internal employees and their CROs about what's been successful, what hasn't, how things can be improved, and what ideas could be used elsewhere.

In our own organization, we have conducted an standard operating procedure sharing exercise. Our client was managing the trial itself. The scientific results delivered by the company and by our organization were the same, but there were differences in various areas of service or activities that led to either faster results or more effective results. Both companies got together and shared policies and standard operating procedures, and both came away with some useful ideas.


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