eClinical news in brief

By Kirsty Barnes

- Last updated on GMT

Related tags: Clinical data, Clinical trial, Clinical research

Outsourcing-Pharma tracks the latest eClinical movements, involving
Medidata, Clinsys Clinical Research, Datafarm and Octagon Research

Eclinical firm Medidata​ and contract resaerch organisation (CRO) Clinsys Clinical Research​ have partnered through Medidata's non-exclusive ASPire to Win program, set up by the firm to support selected CROs in using its eclincal technology. Through the partnership Clinsys plans to implement Medidata´s Rave technology over the next year for capturing, managing and reporting clinical data delivery in multiple mid-to-large Phase II and III trials, on behalf of sponsors in up to 10 countries in the US, Europe and India. Clinsys said it selected Medidata as its electronic data capture (EDC) provider due to "sponsor demand for Rave's web-based, site-friendly features​" that help to increase EDC usage. "For a CRO, having more data collection choices enables us to deliver customised projects that meet our customers' objectives, and we know that clients prefer custom solutions rather than a 'one type fits all' approach​," said Ferrell Drewry, chief information officer and vice president of Biometrics at Clinsys. Recently, IT services firm Court Square Group​ also revealed that it is partnering with Datafarm​ to host its electronic submission software solutions, for life sciences organisations that need to manage their eCTD submissions with regulatory agencies worldwide. Datafarm provides electronic document publishing and regulatory submissions services for the life sciences industry. "eCTD is the only electronic format accepted by the US Food and Drug Administration (FDA) and is the preferred electronic format by the Canadian, European and Japanese agencies today​," said Court Square CEO Keith Parent. "Many small and mid-sized biopharms hire expensive consulting firms to manage their paper-based submissions and convert them to electronic documents. This costly and time-consuming process invites errors that can delay drug approvals by months. That's why we're excited to partner with Datafarm, which provides an industry-leading eSubmission solution​." Court Square said it will help Datafarm customers install and manage their S-Cubed eCTD server-based software or offer them a hosted solution, saving the customer the cost of purchase. This software can be integrated with Documentum, MasterControl, and Microsoft SharePoint Server to provide end-to-end regulatory submission solutions for biopharma companies. "Today, many customers would prefer to buy our software as a service. Small and mid-sized life sciences organisations want to adopt eSubmissions technology but sometimes lack the on-staff skill sets to feel confident that the solution will be managed in compliance with FDA regulations​," said Shylendra Kumar, CEO of Datafarm. "Many of them have asked us about hosted solutions. Our search led us to Court Square, whom we think is the most reliable provider for mid-sized life sciences organisations​." Meanwhile, Octagon Research Solutions​ has announced that the company has experienced "significant growth​" in Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulations Model (SDTM) related business in recent months. Octagon's CDISC-related services include consulting, data conversions and data standards governance to assist clients in their efforts to implement CDISC data standards, particularly the CDISC SDTM, which is the FDA's preferred format for receiving clinical data in an electronic regulatory submission. Octagon said that as the primary trainer for CDISC SDTM for clinical trials, it has trained over 2000 registrants representing over 200 different organisations in 12 countries throughout North America, Europe, and Asia, and has completed the conversion of electronic clinical study data to CDISC SDTM format for over 150 studies across 8 therapeutic areas and 2,500 domains. Dave Evans, chief information officer at Octagon, said: "This massive upswing in interest in CDISC standards is indicative of a strong industry trend toward standardisation across the clinical data lifecycle​". "Companies are realising the importance of clinical data standards and how they contribute to the reduction of time and cost within the clinical data lifecycle​".

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