OCTOBER 2011 NEWSLETTER

Welcome to the Life Science Strategy Group (LSSG) complimentary e-newsletter, keeping you up-to-date with the latest life sciences news and consulting insights.

In this issue, we provide highlights from our latest global survey on Clinical Trial Investigator Satisfaction & Central Laboratory Performance and insight into the Benefits of Scenario Planning.

If there are other specific Life Science topics you´d like LSSG to provide insights on in subsequent e-newsletter editions, please let us know. If you are not interested in receiving our complimentary e-newsletter in the future, please notify us below.

With best wishes,
Life Science Strategy Group

CLINICAL TRIAL INVESTIGATOR SATISFACTION AND CENTRAL LABORATORY PERFORMANCE

New Syndicated Report Examines Clinical Trial Investigators' Satisfaction with Pharmaceutical Sponsors and Clinical Trial Central Laboratories

HOW SATISFIED ARE CLINCIAL TRIAL INVESTIGATORS WITH SPONSORS AND CENTRAL LABS?

Clinical trials, the proving ground for pharmaceutical manufacturers' new therapeutics in development, are becoming increasingly competitive as Sponsors jockey to identify, recruit and retain leading clinicians to serve as investigators for their studies. In the Westernized markets Sponsors face growing pressure from contracting study timelines, increasingly "experienced" patient populations, competition for top-performing clinical trial investigators and the need to build and maintain better relationships with these individuals. Looking to developing regions, Sponsors face yet another bevy of challenges including which markets are going to be the most attractive to develop a new therapeutic? Who are the top-performing investigators? And how can clinical trial samples and logistics be streamlined to avoid unnecessary delays? As a result of these mounting pressures it is clear that the value and importance of the clinical trial investigator to the Sponsor will only continue to grow. As such, it is critical to better understand clinical trial investigator satisfaction in working with sponsors, how Sponsors can improve the process, and ultimately build long-lasting and productive relationships. This is particularly relevant as investigators face increasing demands on and competition for their time and patients.

A vital component of an investigator's experience and ultimate success or failure on a clinical trial is the central laboratory. As Sponsors strive to pull more information out of each clinical trial (often through the collection of biochemical and other patient readouts), and push development into emerging markets with new logistical challenges, the role of the central laboratory will grow. Therefore, it is clear that investigator interaction with and preferences for central laboratories are important elements Sponsors use to ensure investigator satisfaction and to solidify important relationships.

So how satisfied are investigators with clinical trial Sponsors? Where are the disconnects between Sponsors' needs and the "realities" of running a clinical trial site? Which central labs do investigators prefer to work with and what are investigator perceptions of central lab performance? And to what degree does the central lab selected by the Sponsor impact an investigator's willingness to work with a Sponsor on future clinical trials?

According to new research conducted by Life Science Strategy Group (LSSG) with more than 550 clinical trial investigators in North America, Europe, Latin America and Asia Pacific regions, investigators are generally satisfied with Sponsors, but significant differences in expectations exist that can be better aligned. Additionally, investigators state the central laboratory has a significant impact on their overall satisfaction with the clinical trial process, and ultimate satisfaction and willingness to continue on with a Sponsor on future trials. Investigators also show a clear preference for central laboratories and assessment of central laboratory performance. Furthermore, LSSG's report takes an in-depth look at investigator satisfaction, delving into interactions with Sponsors, key challenges in serving as an investigator and preferences/performance for seven of the leading, global clinical trial central laboratories including Covance, Eurofins/Medinet, ICON, LabCorp, PPD, Quest Diagnostics and Quintiles, among others. According to one investigator participating in the research,

"Nice survey with an important message that there are sub-par central labs and there is a need to have greater access to information about future trials by the investigator."

You can learn about these and other key findings and gain in-depth insight into what motivates and drives clinical trial investigator satisfaction with pharmaceutical sponsors and perceptions of top-performing central laboratories in LSSG´s 2011 Clinical Trial Investigator Satisfaction and Central Laboratory Performance Report.

To download complimentary sample pages or to purchase the full comprehensive report, please visit http://www.lifesciencestrategy.com/publications/reports-cro-industry.shtml

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SCENARIO PLANNING

Avoiding the "Rear-View Mirror" Trap

Strategic planning is a challenging endeavor for most pharmaceutical and life science firms. Faced with a growing number of serious business challenges, among them national health care, globalization of markets, reimbursement and pricing constraints, increased regulatory activity and increasing costs across supply chains, it is easy for businesses to fall into the trap of looking into the "rear-view mirror". Making decisions based on what has happened is dangerous and counterproductive. In this period of great uncertainty, companies need to be able to identify challenges that will significantly impact their business and formulate strategies to address them. Given the need to be able to "shift gears" quickly in response to changes in market dynamics, more and more companies are incorporating scenario planning into their brand/strategic planning process.

To date, scenario planning has focused on how forces in the marketplace can affect product or franchise critical success factors (CSFs). The process tends to look at these in isolation, comparing individual scenarios to a base case. However, this approach often fails to recognize the multiple factors that can simultaneously impact a market. As market and business challenges have evolved and become more complex and difficult to address, so has the need for a more dynamic approach to scenario planning.

To address the shortcomings of traditional scenario planning, Life Science Strategy Group, LLC (LSSG) has developed a process that is multi-dimensional and more closely approximates real life market conditions. Like traditional scenario planning, at the core of the process is identification of critical success factors and those issues that are most likely to affect the future market. These are then "mapped" and sensitivities modeled to reflect interplay with various market forces and CSFs, allowing scenarios to be developed that more closely reflect market dynamics and inform strategy decisions to address them. The process relies upon insightful internal workshops, rigorous secondary and primary research to formulate multi-faceted scenarios, expertise in developing dynamic algorithms and easy-to-use quantitative frameworks that accurately model future markets and rigorous analyses to set strategy and develop actionable plans.

To learn more about LSSG´s market research and consulting services or to request a detailed case study, please contact Life Science Strategy Group at info@lifesciencestrategy.com.

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Copyright © 2011. Life Science Strategy Group, LLC.