January 26, 2017 | News, products, and partnerships from around the clinical trial and healthcare community including news from Illumina, Medidata, Rho, and more. 

Illumina and The Children’s Hospital of Philadelphia are currently recruiting participants for a new study called LeukoSEQ, which will use whole genome sequencing (WGS) as part of the diagnostic process for leukodystrophies. The LeukoSEQ study is designed to evaluate the efficacy and clinical utility of WGS testing as a first line diagnostic tool for leukodystrophies. As part of the study, participants will receive results of a WGS test, performed at Illumina’s CLIA-certified Clinical Services Laboratory in San Diego, within six months of enrollment. The study will absorb the cost of the sequencing so that participants do not have to pay for the sequencing test. In order to be eligible to enroll in the study, patients must have undiagnosed abnormalities of the white matter of the brain, with an “index MRI” (i.e. first suspicious MRI) performed no more than two months prior to study referral. The study team will review medical records and radiology images to confirm study eligibility prior to enrollment. The study is open to all residents of the United States. No site visit is required to participate; blood samples will be obtained locally via the referring physician or primary care provider. Press release

Phlexglobal has announced that Chapel Hill, North Carolina-based Rho has implemented PhlexEview4 as its chosen eTMF solution. Delivered via a private cloud in a “Software as a Service” (SaaS) model, PhlexEview4 will support Rho’s commercial and government clients with greater visibility and accessibility to essential documents, and with metrics regarding the completeness and readiness of the TMF. PhlexEview provides a market-leading system for full electronic management of Rho’s client TMFs and reinforces their companywide goal to enhance the quality and speed of clinical trials. “Rho conducted a thorough vendor selection process due to the criticality of this project to Rho’s transformation. Phlexglobal emerged as the right partner due to: the cultural fit between our teams and our shared passion for eTMF excellence; the expertise that Phlexglobal brought to bear that led to our success; and their proven ability to deliver and collaborate effectively. Phlexglobal listened and understood our objectives and requirements – a major differentiator in our experience with software vendors,” said Doug Baldwin, technical operations service leader, Rho, in a written statement. Press release

Medidata announced that Celgene Corporation has expanded its adoption of the Medidata Clinical Cloud to include Medidata’s suite of strategic monitoring tools and data analytics solutions. Building on Celgene’s selection of Medidata as its enterprise technology partner in 2016, the global biopharmaceutical company is now implementing additional Medidata capabilities and machine learning tools to optimize clinical research processes, improve patient outcomes and drive value-based, personalized healthcare. An integral part of Medidata’s cloud platform, CSA integrates patient data from different sources and provides a comprehensive data visualization tool for each subject participating in a clinical trial. The advanced, machine-learning algorithms in CSA enable clinical trial sponsors to uncover complex patterns in clinical trial data, rapidly detect statistical anomalies and identify data quality issues. CSA also provides end-to-end visibility, facilitating collaboration across study teams and helping researchers focus resources where they are needed most. Press release

Genocea Biosciences announced positive clinical results from a planned interim analysis of its ongoing placebo-controlled Phase 2b trial evaluating GEN-003 for the treatment of genital herpes infections. Even in a trial this small, at six months after dosing, GEN-003 demonstrated statistically significant improvements versus placebo across multiple clinical endpoints. Press release