Tarek Sherif, Chairman & CEO
Nobel laureate Françoise Barré-Sinoussi, the virologist credited with co-discovering HIV, calls for revising the way cure research in conducted. “Our proposed data-driven approach to combination cure research is designed to accelerate efforts to transform HIV from an incurable disease to one where we can achieve durable remissions,” said Dr. Barré-Sinoussi. Though specific to combination cure research of HIV, Dr. Barré-Sinoussi and her co-authors’ call for data-driven approach applies for the entire clinical research. The volume of data, which is generated in clinical trials, and a rapid response that classifies and analyzes them is of utmost importance in the healthcare and life sciences industry as market and budget pressures increase. Clinical data management (CDM) is an important component and of critical value in the process and outcome of a clinical trial. CDM takes the prominent position in an environment where the most successful products in pharmaceutical history are now losing patent protection.
The ongoing clinical trials in the organizations are unable to produce patented drugs; eating away the revenues and their margins that have funded original, innovative research and provided returns for both patients and investors. The organizations are struggling to keep up with escalating regulatory requirements, forcing pharmaceutical and biopharmaceutical companies to make operational changes and improve the way they manage information. In this turbulent environment, Medidata Solutions (NASDAQ: MDSO), the multinational computer technology corporation, brings in operational efficiency to clinical trials with its cloud based solutions, inviting accolades from its clients working within disparate geographical boundaries and enabling them to capture greater share of this more than a $100 billion market.
Driving Technological Innovations
Medidata, since its inception, has been serving life science industry by providing a state-of-the-art platform for collecting and managing clinical trial data. Realizing the potential of a unified platform, the company introduced Medidata Rave for capturing, managing, and reporting patient data. Rave combines easy-to-use electronic data capture (EDC) and advanced clinical data management (CDM) capabilities. The platform’s highly scalable, software-as-a-service (SaaS) architecture furnishes a cost-effective approach to quickly implement a single clinical trial or support an enterprise-wide deployment for multiple therapeutic areas, phases and studies—including post-marketing observations and registries. Throughout a clinical trial, Rave provides early visibility to reliable data—the lifeblood of every research organization—enabling study teams to safely and quickly make sound decisions and bring life-enhancing treatments to market.
An interactive implementation approach leverages Rave’s unique self-documenting capabilities to quickly
get clinical trials from design to acceptance testing to ‘First Patient In’ at all organizations’ research sites.
Rave’s extensive capabilities provide a robust platform to manage site-, patient- and lab reported- data from EDC and other systems and rapidly make it available for analysis and submission. Rave includes wide support of industry data standards, flexibility to implement any data management workflow with secure access for all study team members and a rich set of on-demand data extraction (ODM Adapter and Web Services) and ad hoc reporting tools. The platform’s flexibility accommodates organizations’ unique workflow requirements, manages multiple case reports for (CRF) editions, and seamlessly migrates existing data into new forms and structures. Rave provides some of the industry’s most advanced EDC and CDM functionality for data captured electronically, on paper or in labs. Since EDC and CDM are unified in a single platform, no separate tools or integrations are required.
The platform allows for rapid EDC study builds (in days, not weeks) utilizing clinical libraries and centrally managed templates. Rave supports data entry at the site by site personnel, real-time medical monitoring, remote monitoring by clinical research associates and automated query management to speed time to data cleaning and database locking. It also enables dictionary coding through Medidata Coder, real-time E2B transmission of safety cases through Medidata Rave Safety Gateway to eliminate manual reconciliation between clinical and safety databases, and reduced study project management.
Bringing Cost and Operational Efficiency
has become an important part
of our business as the clinical
data and study conduct
standards for industry,
government and academia
Research conducted by independent third-party analysts showed Rave delivered an overall 22.5 percent cost reduction over similar manual, non-integrated processes. While site monitoring remains one of the last clinical research processes that is still done essentially the same way as it was 20 years ago, Medidata’s Rave Targeted SDV, a tool for source data verification (SDV) provided via the Rave platform, is designed to generate significant savings through risk-based monitoring approaches. The cost of 100 percent source data verification accounts for approximately 25 percent of the total cost of a Phase III program, while only delivering 85 percent accuracy at best. Additionally, monitoring end-to-end clinical trial brings with it the burden of maintaining large headcounts and associated infrastructure. Leveraging Medidata solutions together provides a savings opportunity in excess of $9.8 million on a typical Phase III trial.
In addition, Rave’s web-based interface is designed to be friendly and familiar to clinical research coordinators (CRCs) and clinical research associates (CRAs) alike. If a study is global, translated forms will appear to sites in their local language (including Chinese, Japanese or Korean), while all the data they enter is centrally viewable from a single database.
Leading research organizations have consistently been able to translate their complex IT architecture visions into reality thanks to Rave’s wide array of scalable, CDISC and ICH standards-based real-time web services and batch data import and export tools including Rave Safety Gateway for electronic E2B transmission of adverse event data to organizations’ safety system.
Medidata Insights, a clinical business analytics tool offered out of the box, leverages Rave for analyzing cross-site and cross-study key performance indicators. The analytics tool eliminates the large, cumbersome, and expensive installation of standalone products and monitoring processes and utilizes advanced interactive visualization tools to help stakeholders analyze study performance and make better decisions earlier.
By virtue of EHR/EMR integration APIs, Rave can leverage health records for further analysis. Utilizing Rave, organizations do not need to rely on external reporting tools as the platform encompasses 49 standard out-of-the-box reports. Users can generate operational metric reporting using self-service role-based report administration. For PDF and SAS dataset generation, Rave gives self-service unlimited blank, annotated, and patient data PDF generation, as well as online SAS data generation, capabilities.
An exemplary of the efficacy of Rave is RTI International. A distinguished R&D and technical services institute, RTI International was upgrading the technology it uses to provide statistical and data coordinating services for National Institutes of Health (NIH)-funded research. “RTI required the new EDC/ CDM vendor to provide a software-as-a-service (SaaS) solution that could support rapid transition from existing study databases as well as a robust knowledge transfer program to ensure our complete self-sufficiency,” said Rick Williams, senior research statistician, RTI International. “After extensive review of 20 systems, Medidata Solutions was selected and has met these requirements extremely well, along with providing the appropriate process and business support for government-funded research.” The use of Rave produced a high quality of data that conformed to regulatory requirements. “Government-funded research has become an important part of our business as the clinical data and study conduct standards for industry, government, and academia converge,” says Tarek Sherif, Chairman and CEO, Medidata Solutions. “Our ability to support a prestigious organization such as RTI and the research networks it services is testament to our technical leadership in meeting those standards, as well as evidence of the ease in which government agencies can do business with us.”
Holistic Platform for Comprehensive Clinical Trial Requirements
Today’s environment requires the holistic integration of technologies delivered as a platform to drive continuous process improvement and exponential gains in productivity, enabling the technology to transform the clinical research process and accelerate sponsors’ delivery of treatments to market. Medidata’s approach is to unify clinical development and trial execution through a single cloud-based platform that addresses clinical research needs from trial concept to conclusion.