Running a clinical trial or study is a complex and highly regulated process requiring comprehensive expertise, a unified eClinical platform, and advanced statistical analytics. According to two global surveys conducted by Life Science Strategy Group in conjunction with Medidata, there are 14 capabilities required to efficiently conduct a clinical trial – from data capture and management to study planning, patient engagement, study conduct, and monitoring.
The end-users and decision makers surveyed indicated that Electronic Data Capture (EDC) is the most critical software within an end-to-end eClinical platform. However, 13 additional capabilities are also essential, including: Safety Reporting, Clinical Trial Management System (CTMS), Central Lab, Randomization, Electronic Trial Master File (eTMF), Supply Management, Electronic Patient-Reported Outcome/Clinical Outcome Assessment (ePRO/eCOA), Risk-based Monitoring (RBM), Imaging, IRT/IXRS, Data Warehousing, Financial System, and mHealth respectively.
Life Science Strategy Group also polled participants to rate vendors based on their professional services’ ability to complete projects on time, quality of implementation, and accessibility of expertise post implementation. Medidata’s unmatched expertise and operational excellence, from design to implementation at every stage and in every region of the world, was ranked number one.
The life science industry recognizes the need for a comprehensive, unified platform of capabilities that is centered on master data and advanced analytics to enable clinical trial practitioners to accelerate clinical development, focus on patient centricity, and transform the science of clinical development by empowering new precision-medicine based approaches including adaptive, platform trials.
The unified Medidata Clinical Cloud captures the widest array of biomarkers - from clinic and lab data to medical images, sensors, apps, and even genomics - and it empowers data managers and biostatisticians to seamlessly and intelligently randomize, supply, code, and manage safety. In the process, it is now possible to design and execute adaptive trials and studies with synthetic controls. From a trial planning and management perspective, the Medidata Clinical Cloud enables intelligent study planning, feasibility, grants, payments, monitoring, study, and document management that leverages industry benchmarks and artificial intelligence. The results are clinical studies that power innovative study designs, lower patient burden, ease site interactions, and significantly reduce data errors.
The double-blinded surveys featured nearly 300 unique life science respondents from the US, Canada, and Europe, and were conducted in September 2016 and July and November 2017.