Preserving Flexibility in Outsourcing Clinical Services

By Steve Cottrell, inVentiv Clinical Solutions

Every manufacturer and developer of pharmaceutical, biotech and medical device products is being challenged on many fronts by today's market issues. The events of each day bring potential impact on any strategic plans and require manufacturers and suppliers alike to change strategy in timing, resourcing or whether or not to modify or cancel projects. All of these uncertainties require a different set of skills than traditional processes have demanded.

We are all being forced to manage short-term success while looking for ways to fundamentally change the development process. Now more than ever, this requires a high degree of agility with respect to how resources are deployed. Many of the historical resource choices remain available to execute clinical development projects, including executing the entire program internally utilizing in-house staff and contractors, engaging a network of clinical development service providers that offer niche services or a complete turnkey approach utilizing a traditional clinical research organization (CRO).

Successfully executing these strategies requires top talent at both the manufacturer/ developer and service provider level. Identifying that talent and, more importantly, retaining them is more challenging than ever before. The traditional outsourcing model has provided significant value. However, excellence in clinical development is still being sought. The decision is much less 'if' alternative solutions will be utilized, but 'how' they will be utilized.

A complete turnkey approach will continue to provide the least control over the clinical process to the manufacturer/ developer; however, the project manager must have a clear development plan and cost for all services must be contemplated. Furthermore, clients must have strong trust in their service provider in order to avoid costly change fees.

The niche providers or consultants also offer high flexibility and value when managed closely. This strategy can produce highly qualified personnel within a short period of time; however scalability can be an issue if the niche provider has limited resources.

The functional service providers (FSP) model in clinical development has many definitions and has fallen in and out of favor over the past three years. A number of firms hold strong expertise within various functional disciplines which provides a variety of benefits to clients.

The pressure to deliver greater efficiencies by utilizing any of these service levels is here to stay and will continue to expand over time. This is forcing both manufacturers and service providers alike to look for greater opportunities for improved coordination of services not often seen in the past. The opportunity to coordinate investigator meeting management with medical education companies and online meeting services results in a highly interactive and effective process.

In addition, proactively managing the impact of a risk evaluation mitigation strategy (REMS) requirement on trial design, revenue forecasting and patient access as well as utilizing on-call nurses to drive clinical understanding of a trial, assistance with patient recruitment or support of a REMS offering can impact speed and effectiveness.

Finally, having a service provider that can easily access marketing teams early in the process to drive a holistic approach to molecule development, while conducting market and therapeutic analyses to help determine asset valuation in combination with the scientific teams that are performing the clinical development, will provide a stronger asset valuation package for sale of the asset or valuation of the organization

Taking the time to evaluate these strategies in combination with the traditional outsourcing tools will ensure all the potential 'gaps' in clinical development are filled appropriately and the product potential is maximized.

As the choices are made to pursue one avenue or another, one thing is fairly certain: Companies who effectively integrate a sound outsourcing strategy, while leveraging all the tools available to them, will clearly lead within their respective markets. Successful integration of a dynamic outsourcing strategy with a firm that has the depth, breadth and operating philosophy to fit your needs will deliver quality, timeliness and strong cost savings.

Steve Cottrell is the Executive Vice President of inVentiv Clinical Solutions, responsible for Resourcing Operations and Business Development. Cottrell has 20 years of experience in the disciplines of CRO services, online training/learning services, outsourced sales and marketing functions and consulting. He resides in the Somerset, NJ offices of inVentiv.