Most pharmaceutical companies find Contract Research Organizations to be very operational and not especially adroit at using the vast amounts of data collected in analytical ways that positively impact a clinical trial’s performance and costs. Genpact’s 500-plus Life Sciences analysts, by contrast, help pharmaceuticals significantly improve trial cycle times, cost of studies and implementation.
Our approach addresses how Clinical Trial Performance is affected by the cycle of Investigator Performance, Recruitment Rates, Amendments, Deviations/drop-outs and Cycle times.
We begin with a relentless pursuit of answers to these four questions:
'What drives higher cycle times?'
'How do I estimate the complexities of protocols?'
'What drives amendments and how do amendments affect recruitment and cycle times?'
'How is complexity correlated with performance measures across therapeutic areas, phases?'
For example, analysis of Investigator Performance across trials and assessment of their propensity to drop out of trials, or not able to recruit patient types, can help in ensuring that organizations do not have expensive trial amendments. (It has been estimated that 25% of original sites close during the course of a trial.) Our due diligence of investigations include use of historical data on trials from organization databases, and combines our experience of analyzing medical claims. We also use our expertise in Epidemiology and knowledge of medical claims to ID the right patients, map their concentration across geographies and sites where they would be best recruited, and even forecast the expected volume of patients and its impact on the trial cycle times. Further, each selected protocol is analyzed with regard to classes of amendments they undergo and its impact on productivity and cost metrics. Examples: Finding correlation between the volume of amendment and cycle times, measuring the degree of impact on cycle times, and identifying how amendments related to patient recruitment are related to trends in randomization rate.
Genpact helped a top-three global pharmaceuticals company reduce cycle times to help improve the drug development phase. We did this by helping them understand the drivers of amendments and the aftereffects to reduce the cost related to amendments. We also provided a view to what affects investigator performance so they could take preemptive steps to improve overall trial performance.
Genpact is Bronze Sponsor for PMSA's 2013 Annual Conference, Bonita Springs, FL
May 5 - 8, 2013, Bonita Springs, FL