We have seen firsthand creeping costs, delayed enrollment and extended study timelines with previous studies.
Durham, NC (PRWEB) May 04, 2011
Health Decisions, the leading contract research organization (CRO) in adaptive clinical research, has created a strategic development division that aligns the interests of pharmaceutical companies, medical device companies, physicians, and patients with a risk sharing model that accelerates clinical development through incentive based performance and fixed price investments.
Evofem, a women's sexual and reproductive health company, recently chose Health Decisions strategic development division for a global female contraceptive study that will involve 60 sites and 2,800 patients. The objective of the trial is to determine the efficacy and safety of Amphora contraceptive gel compared to a known marketed vaginal contraceptive gel.
“We have seen firsthand creeping costs, delayed enrollment and extended study timelines with previous studies,” said Joe Pike, CEO of Evofem. “With Health Decisions’ strategic development division, we are confident we will not run into these issues and are willing to reward Health Decisions for even greater results.”
On average, only 10 percent of traditional clinical research studies enroll on time and go over budget by 30 percent. Traditional CROs that use a time-and-materials-based model have little incentive to complete a study on time and are actually rewarded the longer the study takes, resulting in more revenue for the CRO.
The fixed-price strategy requires no additional costs outside of the initial partnership from the client, regardless of reworks or delays. Health Decisions becomes a business partner and aligns its goals to the client which is getting safer and better products to patients earlier. Incentive plans are designed to accelerate clinical study performance by reducing timelines focusing on getting the studies completed earlier. Unlike the traditional clinical development model, the Health Decisions strategic develop model rewards performance that results in products to patients faster.
“Pharmaceutical companies and medical device manufactures have been the benefactors of a broken and inefficient process for too long,” said Dr. Michael Rosenberg, CEO of Health Decisions. “Because Health Decisions leverages adaptive process well beyond design, we know our sponsors can have a much more efficient solution to bring their products to market.”
Health Decisions’ new strategic development model creates a sense of urgency to complete the study as efficiently as possible without sacrificing quality to meet the pharmaceutical or medical device companies budget requirements of a fixed-price investment and to be rewarded with incentives for exceeding performance expectations.
Health Decisions designed its new strategy thanks to the results of the Agile Clinical Development approach. Agile Clinical Development takes adaptive research a step further by integrating adaptive design, adaptive operations and Health Decisions' HD360° proprietary technology platform, to target every source of inefficiency in clinical research - from design elements to the day-to-day operational pain points.
Evofem Inc., formerly Instead Inc., advances women's sexual and reproductive health through personal care, disease prevention, contraception and conception products. Evofem is a unique provider of feminine hygiene, in that it doesn’t manufacture other consumer products such as diapers, cleaners, and other unrelated products. Evofem is dedicated and passionate about the struggles and issues of all women and work to improve their lives, not only through innovation but through charity and working with other people and organizations with the same mission.
About Health Decisions
Health Decisions is a global contract 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 studies across all major therapy areas.
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