CRO

Extended and expanded: INC Research and Medidata enter into new tech partnership

INC Research is already the most loyal partner to Medidata Solutions, having been using all nine products of the data technology company. Now, as the two celebrated the partnership’s 10-year anniversary, the CRO has decided to extend their contract for a few more years and start using two more products of Medidata.

The two new applications added to the partnership are Medidata Payments—which streamlines clinical site payment workflow—and Medidata Centralized Statistical Analytics (CSA), both available through the Medidata Clinical Cloud platform.

The CSA system uses “advanced, machine-learning algorithms” to navigate complex patterns in clinical trial data and help sponsors quickly detect anomalies and other data quality issues, Medidata’s COO Mike Capone told me in an email interview about the new deal.

“Trials have become so complex, and so data intensive, that humans are less able to find all the errors,” said Capone, and that’s where Medidata CSA comes in.

The system is novel because of its features of automation, multivariate methods and consistency, as Capone introduced.

“[It] can process an entire clinical trial database in less than an hour, providing comprehensive study information without manual configuring or coding,” he said. “[It] compares information across variables, across patients, across sites, and across studies using uniform methods to ensure consistent scoring of data quality.”

Medidata’s system also allows INC to use a single, unified platform to manage study data from start to finish, Carmen Weese, EVP of Biometrics at INC told me. The more efficient approach saved the CRO from previously having to take data from multiple sources using different reporting systems to monitor and review trial data.

INC Research started working with Medidata in 2005 on data management services, then joined the latter’s partner program in 2006 and has since then seen their partnership grow. In 2013, INC Research became the first CRO to had obtained accreditations to all nine Medidata products available at that time, and it is still the only one with that deep a connection with the New York-based tech company.

In fact, that past experience and partnership was a key factor in INC’s decision to adopt Medidata CSA, and it “was the next logical step for INC Research,” Weese told me.

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INC has been pairing Medidata’s cloud-based clinical technology platform with its own Trusted Process methodology, a model that INC CEO Alistair Macdonald appraised as “instrumental” in supporting more than 360 studies by INC.

To Medidata, INC is also more than a client that it is selling software to.

“INC staff participate in focus groups for virtually every product we sell and they have been early adopters of new Medidata technology including CTMS, Rave, Payments, Balance and CSA,” Capone said. “INC frequently provides feedback to Medidata on our individual products and our platform.”

The level of collaboration between the two has warranted INC opportunities to preview Medidata’s product even before an official release. That happened last year in the case of Medidata Rave, a tool for capturing, managing and reporting patient data, Capone said.

“[That] was a non-validated, unreleased version of Medidata Rave that INC staff used exclusively to assist Medidata with product testing,” he said. “They provided us with detailed feedback on the look, feel and functionality of Rave and that feedback has been added to the product roadmap.”

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As with CSA, Weese said INC had also piloted the program prior to a formal implementation. The CRO has been utilizing the Patient Profiles tool since it was acquired by Medidata in 2014, and that is the data base for CSA. They have also conducted a patient profile workshop to optimize the CSA output, according to Weese, who said INC will continue to provide Medidata with feedback on how to refine the tool.

Besides INC, Medidata, founded in 1999, have also formed relationships with almost every major CRO in the industry, including Covance, Icon, Parexel, PPD, Pharm-Olam, PRA Health Sciences, SynteractHCR, WuXi AppTec, etc. According to the company’s profile, hundreds of life science organizations have used its platform, in over 12,000 trials in more than 130 countries.

Editor's note: This story has been updated with revised number of trials that have used Medidata's platform.