May 30, 2017 | May was full of exciting news in the clinical trial and healthcare community, including partnerships and products from CluePoints, The Jackson Laboratory, Medidata, and more.

CluePoints, winner of the 2017 Best Practices Award for Clinical Data Intelligence, announced that it will be expanding its operations in the U.S. with the opening of a new office in Wayne, PA. The expansion marks a key milestone in CluePoints’ ambitious growth strategy that will see the company build its infrastructure to support its rapidly growing U.S. client base. CluePoints’ U.S. operations are being led by Steve Young, chief operations officer, who will be supported by project managers and data analysts at the new office. Their focus will be on developing and supporting both existing and new customers in the region, from small and mid-size organizations to large pharmaceutical companies and CROs. “A strong presence in the U.S. is a critical next step in our strategy, following momentous growth in demand for our solutions. Not only are our customers experiencing significant tangible cost benefits but industry regulations, especially the imminent revised ICH E6 (R2) GCP guidance, now insist that sponsors have a central statistical approach to driving data quality, integrity and oversight,” comments Steve Young. “We chose Wayne, PA for our operations because it is located within a key region for biotech, CRO, pharma and technology companies, and provides access to a rich talent pool to support our continuing growth.” Press release

The Jackson Laboratory is teaming up with the Connecticut State Colleges & Universities (CSCU) system to train and prepare students for careers in bioscience and biotechnology. The formal partnership establishes the "Genomics Workforce Institute". Goals include promoting professional development, faculty collaboration, hands-on training for students, curriculum development and direct access to potential employers. The development follows a pilot program funded mainly through a $12 million U.S. Department of Labor grant to create new and revise existing health and life sciences programs across the country. Grant funding for the program ended this year, and JAX has agreed to continue and enhance the program and partner with CSCU. Funding for the program will be developed, said JAX's Melanie Sinche, director of education. Press release

On the heels of its recent acquisition of CHITA, Medidata announced the availability of its regulated content management (RCM) platform, Medidata RCM. In collaborating with Box, Medidata has expanded the Medidata Clinical Cloud to include breakthrough products for standard operating procedure (SOP) management and electronic trial master file (eTMF) archive. These unified solutions provide customers the ability to manage all content, data and workflows in a single, integrated platform that meets the most rigorous usability, scalability, performance, compliance, and security requirements. The life sciences industry has historically viewed regulated content management systems as a "painful necessity" rather than a valued tool. Such perceptions have persisted due to outdated technology infrastructures, disparate solutions and clunky, pre-cloud UX designs. Yet, these systems are needed to ensure adherence to SOPs and regulatory requirements for FDA and other regulatory body inspections. Medidata has taken a different approach with its RCM platform. The collaborative solution is designed to focus on the most important aspect of advancing clinical innovation, the user, by empowering key R&D players—sponsors, sites and contract research organizations (CROs)—to seamlessly manage regulated content in a single, unified platform. Press release

mProve Health announces unprecedented 12-month growth and the addition of 25% more new pharmaceutical companies and CROs to its client base. With contracts for research studies at 18 of the top 20 pharmaceutical companies and more than 15,000 clinical research sites in over 60 countries engaged to enroll patients on mProve’s applications, the company is expanding. mProve Health recently made a strategic move into new, industrial- and tech-inspired, open-concept offices in the Washington, DC metro area. This comes following 16 new hires in the past 12 months and the establishment of a UK-based team in London. “mProve Health has experienced record growth in the past 12 months,” wrote Jeff Lee, Founder and CEO. “Our traction among top 20 pharmaceutical companies is a direct result of our team and their ability to consistently deliver high-quality software and services. Opening our new Washington, DC headquarters, outfitted to attract and retain the best and brightest, was a strategic move to best position us for the future.” Leaving behind a startup-style office space, and moving the company into new, custom-designed headquarters will allow mProve Health to plant firm roots. mProve Health is Lee’s fourth mobile technology venture. Co-founded with Denis Curtin, CSO, a pharmacologist and pharmaceutical industry veteran, the company is challenging the legacy of patient technology used in clinical research studies. By expanding mProve’s foothold in Washington, DC, the leadership team continues to remain actively involved with regulators shaping the future of mHealth policy. Press release

Medherant has appointed Laboratoires Plasto Santé to manufacture its first drug delivery patches. The first batch of patches, based on Medherant’s proprietary TEPI Patch technology, will be used for clinical studies of the company’s revolutionary ibuprofen patches. The new studies, designed to test safety and efficacy, are planned to start in the autumn of 2017. Press release

Nanobiotix announced its first set of clinical data from its immuno-oncology (IO) program, showing the potential ability of NBTXR3 to transform “cold” tumors into “hot” tumors. Laurent Levy, CEO of Nanobiotix wrote, “Being able to transform cold tumors into hot tumors is one of the most challenging and promising topics in oncology. This preliminary clinical data indicates that NBTXR3 could play a key role in unlocking this potential. Given NBTXR3’s universal type mode of action and good safety profile, NBTXR3 could change the treatment landscape in numerous solid tumor cancers.” Press release

Commonwealth Informatics announced the general availability of CVW Longitudinal, the first module of the Commonwealth Vigilance Workbench (CVW). CVW is an integrated technology platform designed to help pharmaceutical and biotechnology companies manage a compliant signal management process incorporating analytical evidence for safety from multiple internal and external sources of data. Recent research efforts by several multi-stakeholder public-private partnerships have demonstrated the value of enhancing safety surveillance systems with analysis of longitudinal healthcare data resources. CVW Longitudinal delivers the statistical methods, insightful graphical displays, and data interfaces needed to apply this research to signal detection and signal refinement for drug and vaccine safety. Building on methods research carried out by the Uppsala Monitoring Centre on “temporal pattern discovery in longitudinal data,” CVW Longitudinal provides the new methods as a packaged software service with the data handling, documentation, support, and security needed for production operations within the regulated pharmaceutical industry. CVW Longitudinal can be used with a wide range of healthcare data sources such as electronic medical records and insurance claims. It provides out-of-the-box analytics for multiple electronic medical record and health insurance claims databases and is cloud-based with no IT infrastructure required. “The Commonwealth Vigilance Workbench is designed to help safety teams answer complex questions rapidly and accurately. Pharmaceutical and biotechnology companies and government regulatory agencies are looking for ways to efficiently incorporate healthcare data sources into safety signal management. CVW Longitudinal combines innovative signal detection methods with a streamlined user interface allowing teams to rapidly access these rich data sources to more effectively detect, refine, and validate potential safety signals that may impact patients,” wrote Geoff Gordon, Commonwealth President and Founder. Press release

Greenphire announced that it has appointed Claudine Paccio to the role of Chief Operations Officer. Claudine comes to Greenphire with nearly three decades of experience building and leading global teams committed to operational excellence. In her role as Chief Operations Officer, Claudine will oversee solution implementation and the ongoing success of Greenphire’s client partnerships. Claudine brings to Greenphire a unique blend of experience derived from prior leadership roles with large global enterprises such as General Electric and Dell Computer as well as smaller eClinical organizations like BioClinica and CRF Health. Throughout her career, Claudine has demonstrated an exceptional ability to drive operational excellence in dynamic and rapidly scaling environments. Press release

Bracket announced the launch of a cloud-based service for SmartSupplies, its clinical trial inventory management software suite. This launch marks the first hosted solution of SmartSupplies since Bracket’s acquisition of CLINapps in 2016 and is applicable to all modules of the SmartSupplies suite. SmartSupplies, an enterprise clinical trial material management software solution, provides end-to-end clinical inventory management for sponsors. The release of the cloud-based offering will enable companies without their own IT infrastructure and servers to easily and securely run and manage the application. Built atop Oracle Cloud Services, the cloud-hosted solution will facilitate enhanced integration with other eClinical systems as well as allow end users and clinical research associates (CRAs) to share data seamlessly and instantaneously without geographic constraints. Bracket’s hosted SmartSupplies solution is competitively priced and provides a cost-effective alternative for sponsor companies deploying the enterprise solution. This cloud-based option allows sponsors to eliminate in-house hardware maintenance and management for a reduced IT footprint.  Other advantages include:

• Reducing outsourced hosting, off-shore contractors and vendors for decreased third-party costs;
• Enabling proactive support and system health-checks from Bracket’s support team;
• Facilitating better integration with other eClinical systems and collaboration across sites; and
• Ensuring a well-maintained regulatory environment and robust business continuity.

The transition of SmartSupplies to the cloud is seamless for existing customers, causing no disruption to the end user. Press release