NEW YORK--(BUSINESS WIRE)--Running a successful clinical trial or study is a complex and highly regulated process that requires vast operational expertise, a unified eClinical platform, and advanced statistical analytics. According to two global surveys conducted by Life Science Strategy Group in conjunction with Medidata (NASDAQ: MDSO), the leading global provider of cloud-based technology and data analytics for clinical research, 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.
“This survey further reinforces Medidata’s strategy to bring a complete range of data-driven and unified eClinical capabilities to the market,” said Glen de Vries, president at Medidata. “Our clear leadership in the eClinical categories explains our ability to drive value for our clients with our next generation research and analytics platform, today and in the future.”
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 end result are clinical studies that power innovative study designs, lower patient burden, ease site interactions, and significantly reduce data errors.
“The life science leaders who participated in our survey indicated that a true eClinical platform demands more than just EDC to address today’s challenges,” said Jon Meyer, co-founder and managing member of Life Science Strategy Group. “A robust, unified platform that brings together data capture and management with clinical operation capabilities can maximize the success and efficiency of a clinical trial.”
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.
Medidata is reinventing global drug and medical device development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including over 950 global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations.
The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management and reporting.