Exporting proprietary clinical trial documents and metadata from SharePoint

Helping clients bring life-improving and life-saving drugs and treatments to market faster is no small task. It takes expertise, the drive to innovate, constant learning, and a high attention to detail. This effort is aided by finding the right supporting technology solutions delivered by partners and teams who bring good chemistry of their own to the task at hand. Microsoft’s SharePoint was able to deliver a strong foundation for PRA Health Sciences (PRA) to manage thousands of documents during their clinical trial process, but it was the flexibility, simplicity and view capabilities of Vyapin’s SPListX for SharePoint that delivered the winning combination PRA needed to drive even more value for their clients.

About PRA Health Sciences

Raleigh North Carolina is home to one of the world’s leading Contract Research Organizations, PRA Health Sciences (PRA). The organization conducts complex global clinical trials across all therapeutic areas. It also provides outsourced clinical services for all phases of pharmaceutical and biotech drug development for its clients. With over 30 years of experience and 10,000 employees operating in more than 80 countries, PRA has been bringing to market everything from niche therapies and treatments to blockbuster drugs.

At the center of any PRA story are the company’s clients and the people whose lives they help improve. Innovation is what PRA is all about and technology plays a critical role in ensuring a great experience for clients when moving their products to market. With the innovation spirit and client’s satisfaction top of mind, the team at PRA embarked on a new project to improve the management of documentation and metadata stored in support of clinical trials.

The Business Challenge

When PRA is contracted by a Sponsor to manage a trial there are volumes of documentation required to support the process. A trial lasts on average between 18 and 24 months and each one can generate between 10,000 and 80,000 supporting documents. Despite the large number of documents in play, it is essential that PRA have a way to bulk export specific documents requested by the Sponsor throughout or at the end of the trial.

Wanting to provide the best possible experience for Sponsors and PRA users, the PRA team sought to deliver a new Electronic Trial Master File (eTMF) solution with more capabilities than their existing system. The new solution needed to provide Sponsors with the ability to access their documentation and metadata during the trial and allow them to filter, create desired views, and export selected documents.

One of the biggest challenges to ensuring a positive experience for Sponsors is meeting all of the regulatory rules surrounding protection of client data while providing a seamless user experience.

When a trial is complete, the Sponsor owns the data. PRA wanted to be able to easily provide Sponsors with a final export of all their data, including any associated metadata, in XLSX or XML format.

Solution: NextDocs eTMF with Vyapin’s SPListX

The PRA project team engaged NextDocs, a partner specializing in compliance solutions for regulated life sciences companies. PRA chose to implement NextDocs’ Electronic Trial Master File (eTMF) solution which is based on Microsoft SharePoint. Still to tackle, however, was the ability for PRA to export selected documents using federated identity—must-have features if PRA was to provide a contracted end of study deliverable to its Sponsors. To overcome these technical challenges, NextDocs recommended Vyapin’s SPListX for SharePoint tool. PRA conducted further testing and validation prior to utilizing the tool for Sponsor deliverables.

Federated Identity

PRA conducted an extensive evaluation process of both SPListX and competitive offerings. The evaluation revealed that the competition was no match for the Federated Identity feature of Vyapin’s tool. PRA utilizes single sign-on for the majority of their applications and SPListX’s Federated Identity feature fit seamlessly into this approach.

SPListX Meets Export Needs with Added Value

Providing PRA with the ability to filter on volumes of Sponsor documentation and export selected documents was key to meeting client deliverables with the new eTMF solution. PRA’s SharePoint document management system contained customized fields which made this more challenging. Fortunately, SPListX allows clients to create a desired view in SharePoint pinpointing selected documents for export which the tool can then access to extract the desired documents and metadata.

As PRA worked more closely with SPListX they discovered the tool provided added bonuses such as the ability to export only the latest version of documents and the retention of document creation and modified dates. These capabilities make it that much easier for Sponsors to work with their data.

The features and flexibility of the SPListX product allows PRA to be even more innovative for their Sponsors.

Collaboration and team work

Vyapin’s sales and support teams were actively engaged in the project from the beginning. During the rigorous evaluation and testing process, Vyapin was readily available to help with questions and demonstrations. The Vyapin team even went as far as incorporating changes to the product to fit exactly PRA’s needs. According to Brandi Bell, Manager of Document Management at PRA, Vyapin helped them learn the product and explore its full capabilities in their environment. The Vyapin solution provided the combination of features, product flexibility, and pricing that helped PRA to meet their initial goals for the new eTMF.

PRA now has a platform on which it can continue to innovate and deliver new and enticing client experiences.

Benefits of the Vyapin solution for PRA

  • Federated Identity enabling secure and easy access
  • Flexibility and future opportunity to deliver more value to clients using SPListX
  • Ability to access SharePoint views to export selected documents and metadata based on specific criteria
  • A strong partnership and responsive support team at Vyapin to support PRA’s success

This case demonstrated what mixing together innovative ideas with flexible solutions and highly engaged teams can & do improve the lives of people working hard to get critical products to market.

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