New White Paper Reports the Five Essentials for Minimizing Clinical Development Risk
CRO Health Decisions explains how a systematic risk mitigation system can prevent undue FDA rejection
Durham, NC, February 20, 2010 --(PR.com)-- "If a drug works, there should be no reason for a clinical trial to fail," declares a new white paper from Health Decisions (www.Healthdec.com), a full-service clinical research organization (CRO) specializing in high-efficiency adaptive solutions. This may seem like common sense, but many potentially valid drugs are denied FDA approval because of flawed clinical data that undermines the validity of overall efficacy and safety findings. Titled "What You Don't Know Can Hurt You: Five Essentials for Minimizing Clinical Development Risk and Ensuring Your Greatest Chance of Success," the report shows how untreated quality issues at even a single investigator site can negatively impact the results of an entire study. It identifies the elements that every trial should deem mandatory in order to avoid such unnecessary failure. The white paper is available as a free download from the company's website at www.HealthDec.com/page/five-essentials.
"What you Don't Know Can Hurt You" includes topics such as:
- Why risk is at an all-time high in clinical development and the factors that make some trials more risk-prone than others
- How to employ systematic risk mitigation for any trial, including the five essentials and why they're so vital
- Risk management tips for global and complex trials
- The type of information you should be collecting beyond patient data, how to capture it, and what to do with it
"What you Don't Know Can Hurt You: Five Essentials for Minimizing Clinical Development Risk and Ensuring Your Greatest Chance of Success," is available for download at www.HealthDec.com/page/five-essentials.
For more information, please contact Katie Hendrick, Marketing Specialist, by email at [email protected] or by phone at +1.919.967.1111 x116.
About Health Decisions
Health Decisions (www.HealthDec.com) is a global clinical research organization (CRO) committed to helping drug and device companies achieve greater success. Our sponsors rely on us to help them prove the value of their pipelines both faster and with the smartest possible allocation of funds. Through Agile Clinical Development-a strategic combination of adaptive design and adaptive operations-Health Decisions optimizes every facet of clinical research from design protocol to the most detailed day-to-day management, so sponsors can make the most of competitive market opportunities.
Health Decisions is headquartered in Durham, NC, with over twenty years of experience helping sponsors achieve success in Phase I-IV trials across all major therapy areas. For more information, please visit the company's website at www.HealthDec.com.
Katie Hendrick, Marketing Specialist