December 21, 2016 | News, products, and partnerships from around the clinical trial and healthcare community including news from Almac Clinical Technologies, Commonwealth Informatics, Linguamatics, and Centrexion Therapeutics.  

Almac Clinical Technologies announced a collaboration with Exostar, whose cloud-based solutions help companies in highly-regulated industries mitigate risk and solve their identity and access challenges. The companies are working together to provide Single Sign-On (SSO) and Federated-Authentication access to eClinical applications used to support clinical trials, including Interactive Response Technology. In its first eClinical proof-of-concept collaboration with Exostar, Almac successfully integrated its market-leading IXRS 3 IRT with Exostar’s identity and access management platform for life sciences. As a result, Almac’s global client base is set to benefit substantially through simplified credential management for both clinical sites and trial sponsors - ultimately helping to streamline clinical trial workflows. “The clinical trials process is dynamic and complex.  With IXRS 3, Almac expedites drug discovery by bringing constituents, materials, and data together so the right people have access to the right information and supplies at the right time,” said Kenny Kong, Exostar’s Director of Life Sciences and Health IT in a written statement.  “By federating to the Exostar platform, Almac is furthering the value of their solution by enabling SSO for their clinical application, which eases the access burden on study sponsors, improves the site user experience, and raises the level of security.” Almac and Exostar press release

Commonwealth Informatics is announcing a new agreement with the FDA to provide expanded consulting and support for the FDA Safety Signal Detection Software Infrastructure. 

This is a follow-on contract to the FDA Agreement announced in June and  has the following attributes: 

• One year commitment of ~$900K  for support and consulting and four additional option years with an increasing amount each year.
• Support for one of the largest implementations of  Oracle Empirica Signal as with up to 300 users accessing the suite to track the safety of marketed drugs and those in the approval process - recent batch of new drug approvals requires more safety review.
• The contract provides support for the FDA’s 21st Century regulatory review process initiative  

Clinical Informatics News covered Commonwealth Informatics’s partnership with the FDA earlier this year.

Linguamatics introduced the I2E Asynchronous Messaging Pipeline (AMP) platform to help healthcare professionals find critical clinical insights faster using Natural Language Processing (NLP). The addition of I2E AMP to Linguamatics’ NLP text mining solution, I2E, makes the management of background healthcare workflows more efficient, and provides scalability as NLP text mining requirements grow. By automating the text mining of real-time documents, I2E AMP can provide healthcare professionals with rapid insights and help them make timely – and potentially critical – clinical decisions. Linguamatics press release

Centrexion Therapeutics announced positive topline data from its Phase 2b study of CNTX-4975 in patients with knee osteoarthritis (OA) pain. In the randomized, double-blind, placebo-controlled, multicenter TRIUMPH study, CNTX-4975, Centrexion’s proprietary lead pipeline candidate, met its primary endpoint of a reduction in pain with walking through 12 weeks with high statistical significance and demonstrated a duration of effect of at least 24 weeks after a single dose. At the 1.0 mg dose, two-thirds of patients achieved 50% or greater reduction in pain and nearly one-quarter of patients achieved a 90% or greater reduction in pain. Centrexion Therapeutics press release