TKL Research Selects Medidata Solutions’ Clinical Trial Management System To Drive Future Growth

TKL Research, a clinical research organization (CRO), has selected Medidata CTMS™, a leading software-as-a-service (SaaS) clinical trial management system offered by Medidata Solutions (NASDAQ: MDSO), as part of an initiative to expand its clinical trial operations. As TKL’s operations accelerate, delivering on its reputation for rapid study startup times and first-rate patient enrollment practices will become increasingly complex. Medidata CTMS allows TKL to identify sites that can rapidly enroll the right patients by measuring actual recruitment milestones against site-forecasted times. To meet the growing needs of TKL’s multisystem, multi-trial operations, the study metrics captured by Medidata CTMS are being used to evaluate resource deployment and streamline processes—from site selection to site payment.

TKL’s CTMS selection process was spearheaded by Kevin Vernarec, Vice President of Operational Excellence, whose refined approach to clinical operations and management has been shaped by more than 26 years of experience at leading pharmaceutical and CRO companies. With an eye towards creating greater cross-trial efficiency—a key element of TKL Research’s strategy to scale its business—Vernarec and the company’s management team selected Medidata CTMS based on its abilities to track and evaluate processes.

• “We expect that the robust functionalities of Medidata CTMS will allow us to determine where opportunities lie and track improvement metrics over time,” said Vernarec. “We are aiming to reduce study start-up time by two to four weeks, with no added costs, just efficiency improvements – giving our clients a competitive edge.”

By driving decisions that fine-tune operations and focus resources, Medidata CTMS allows TKL to gain the operational leverage needed to scale its business.

• “Medidata CTMS helps evaluate operational effectiveness, implement changes and measure their impact quickly,” said Glen de Vries, President, Medidata Solutions. “Our flexible, modular system provides support to individual functions as well as the ability to review data from across an organization.”

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About TKL Research

Headquartered in Rochelle Park, New Jersey, TKL Research is a full-service international clinical research organization (CRO) serving the pharmaceutical, biotechnology, medical device and consumer healthcare industries. TKL Research provides comprehensive clinical trial management services for Phase I-IV clinical research studies, including an inpatient Phase I facility and outpatient specialized research clinics while delivering to our clients a competitive edge with accelerated enrollment.

About Medidata Solutions Worldwide

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

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