Medidata Unveils Latest Release of Medidata Clinical Cloud

Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the latest release of the Medidata Clinical Cloud™ and the immediate availability of new capabilities and enhancements that broaden the company’s platform of advanced technologies and data analytics. The new features, designed to optimize clinical trial processes and enhance sponsor-site relationships, will be showcased at the upcoming Medidata Symposium Europe 2014 in Lausanne, Switzerland on October 14-16.

“We’re constantly broadening the Medidata platform to empower sponsors with innovative technology solutions that bring efficiencies to every part of the drug development process, from study planning through execution, management and reporting,” said Glen de Vries, Medidata’s president. “This release represents a major milestone for Medidata and underscores our commitment to transforming clinical trials with best-in-class technology solutions that help our customers speed up the delivery of safe, new therapies to patients worldwide.”

Addressing the needs for unified user administration, end-to-end site payments and improvements to site monitoring processes, the new release of the Medidata Clinical Cloud offers life sciences companies new capabilities to drive efficiencies that reduce the cost, risk and long timelines associated with clinical trials.

“INC Research is accredited across the entire Medidata Clinical Cloud, so we are pleased with Medidata's continued commitment to enhancing their cloudbased clinical research platform,” said Alistair Macdonald, chief operating officer, INC Research. “The added system configurability and new site payment functionality support INC's focus on site relationships by providing added flexibility to better serve the needs of our clinical research site partners.”

Alan Louie, IDC Health Insights’ research director of clinical development, strategy and technology, explained: “With the ongoing shift away from clinical trial platform customization by leading pharma, and the increasing use of eClinical platforms by emerging and mid-tier players, eClinical solutions that enable and empower configuration over customization are enabling trial sponsors to more quickly and effectively advance their studies. The ability to easily conduct ‘ad hoc’ assessments of trial performance, create form templates to more easily and routinely respond to required regulatory reporting (including language and geography-specific requirements), and capture and track trial documents seamlessly are among the key new platform features being sought by trial participants as they seek to deal with increasing trial complexity.”

Among the key enhancements provided by the latest release of the Medidata Clinical Cloud is further simplified and centralized user administration throughout the technology platform. Now, an administrator can manage a comprehensive range of user roles across the entire Medidata suite of solutions (including Rave, Balance, Grants Manager, Coder and Patient Cloud), increasing the speed of study start-up and enhancing the productivity of clinical trial sites.

The new release also adds new flexibility to site payment and monitoring capabilities:

• End-to-End, Budget-to-Payment Automation: Encompassing trial design, budgeting, contracting and site payment, Medidata CTMS™ offers an automated, end-to-end solution that increases the accuracy and timeliness of payments to clinical trial sites. In addition to automatically triggering payments based on patient visits recorded in Rave, Medidata CTMS now includes the capabilities to pay clinical trial sites for specific, completed procedures. The enhancements are designed to help life sciences companies accurately calculate site payments by automatically subtracting the costs of incomplete procedures, thus eliminating manual administration. This automation allows life sciences companies to greatly reduce the overhead traditionally required to perform manual workarounds. Furthermore, the enhancements facilitate more effective management of budget amendments and renegotiations, ensuring payments to clinical trial sites reflect the most current negotiated costs.
  

“On average, investigators are reimbursed more than three months after a milestone completion and, as a result, the financial burden of participating in clinical research becomes too high for investigators,” said Michelle Marlborough, Medidata’s vice president of product strategy. “With the end-to-end payment capability built into our platform, sponsors can enhance site satisfaction by paying investigators on time, increasing the likelihood that they’ll participate in future studies.”

• Enhanced Site Monitoring Capabilities: As part of the company’s efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide, Medidata has enriched its platform’s capabilities to give sponsors easier and more intuitive access to information on enrollment, milestone tracking, key performance indicators, trial activity and subject enrollment. Also, trial managers can now configure visit letters to meet the needs of any study, without engineering or technical expertise. These visit letters and other monitoring documents seamlessly flow into Veeva’s electronic trial master file portal Vault eTMF—via an integration with the Medidata Clinical Cloud—ensuring submission readiness in real time.

Medidata Symposium provides Medidata clients and service partners with opportunities to learn and share best practices for the effective design, planning, execution, management and reporting of clinical studies using the Medidata platform. Hosted by Nestlé, this year’s conference includes role-based interactive tracks and sessions covering study design, clinical finance, data management, trial management, site engagement, and randomization and supply management.