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Company Integrates eTMF, CTMS and Investigator Portal to Bring Together Essential Clinical Trial Constituencies onto One Management System
NextDocs Corporation today announced that one of the world’s leading pharmaceutical and biologics companies has leveraged the NextDocs clinical solution suite across more than 200 clinical trials to manage regulated content and compliance, and bring together clinical trial constituencies onto a single management system.
The average cost of bringing a new drug to market is $1.3 billion, with approximately 90% of that expense associated with Phase III trials. In addition, pharmaceutical companies are seeing that up to 50 percent of drug discovery and development work is being done “outside their firewalls.” As a result, these companies are seeking new strategies and technologies that accelerate and drive down the cost of running clinical trials by promoting internal and external information exchange, collaboration and compliance.
The NextDocs clinical document management suite allows companies to leverage technology to manage clinical trials more effectively as it significantly reduces the time they have to spend on managing paperwork. The NextDocs Electronic Trial Master File (eTMF) along with Trial Exchange (TrX) help pharmaceutical companies to streamline processes, improve transparency and quality, automate information exchange, and reduce the administrative overhead associated with running clinical trials.
This Global Fortune 500 pharmaceutical company, one of the ten largest pharmaceutical companies in the world, initially deployed the NextDocs eTMF solution over two years ago to manage clinical trial documents. In 2013, the company expanded the deployment to include Clinical Research Organization (CRO) access. Subsequently, the company deployed the NextDocs Trial Exchange (TrX) investigator portal solution to provide external access to a user community of over 30,000 investigators across more than 10,000 trial sites.
The NextDocs eTMF solution provides a clinical collaboration platform for managing trial documentation that incorporates best practices in document management from across the life sciences industry. The pharmaceutical company’s CRO partners are able to access the system securely thus enabling true sponsor/CRO collaboration in the contribution and management of TMF content.
The NextDocs Trial Exchange solution is a clinical portal that utilizes one single repository for both trial sites and sponsors, accessed through two different user interfaces. The solution’s easy-to-use interface for investigators plugs directly into the eTMF without additional routing, allowing trial site staff to contribute and access documents with minimal training. Trial Exchange has apps to support completing trial work through mobile platforms, including Windows 8 and iPad.
Enabling investigator sites to easily download and upload key study documentation electronically and directly into an eTMF workflow dramatically reduces the need for printing, scanning, collection and reconciliation of documents. This reduces costs, speeds processes and provides a much clearer chain of custody for this regulated documentation.
“With the NextDocs clinical solutions suite, this major global pharmaceutical company is bringing together all its primary constituents – including internal project teams running the trials, the CROs they do business with, and the investigators participating in the trials – to collaborate, communicate and enforce compliance. The time and cost savings directly impact the speed and success of their clinical trials,” said Zikria Syed, Chief Executive Officer of NextDocs.
This client has further integrated its NextDocs clinical solutions suite with its Clinical Trial Management System (CTMS) to ensure trial information is not duplicated across multiple systems. As an example, when a new study is defined in the CTMS, the NextDocs API enables the provisioning of a fully configured eTMF workspace to support collecting documentation. The solution is also integrated with Exostar’s Life Sciences Identity Hub, to further coordinate credentialing and authorization of external users including investigators and CRO partners.
More than 100 life sciences companies rely on NextDocs solutions, including 5 of the top 10 pharmaceutical companies and two of the largest Clinical Research Organizations (CROs). For more information on NextDocs solutions, visit www.nextdocs.com.