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Health Decisions 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.
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.