Friday, January 29, 2016
A collaboration of companies was formed to provide a world-class outsourcing solution for the pharmaceutical, biotech, and medical device industries that is both cost-effective and operationally efficient.
CRF Health, a global provider of eCOA solutions for the life sciences industry, announces the appointment of Claudine Paccio as the company’s senior vice president, Delivery Services. Paccio will head-up client delivery and development activities at CRF Health, where she will provide leadership, structure and processes to enhance the delivery of the company’s services and solutions to its rapidly growing customer base.
Virginia Bio, a statewide nonprofit association representing life science industry in the Commonwealth of Virginia, elected five new members to their board of directors for a term of three years. The election took place in December at the Virginia Bio Annual Membership in Richmond, Virginia.
BioClinica, a specialty clinical trials services and technology provider, has acquired Clinverse. The acquisition expands Bioclinica’s offerings into the growing market of automated financial management technology solutions for global clinical trials. Clinverse is the latest investment that Bioclinica has completed to build the company into a leading provider of solutions that bring quality and efficiency to every phase of clinical trial development.
Alkermes has announced preliminary topline results from FORWARD-3 and FORWARD-4, the first two of three phase III efficacy studies to read out from the comprehensive FORWARD pivotal program for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients who have an inadequate response to standard therapies for clinical depression. Neither of the two studies met the prespecified primary efficacy endpoint, which compared ALKS 5461 to placebo on the change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS).
The Alliance for Clinical Research Excellence and Safety (ACRES), a global public-interest collaboration building a comprehensive system to transform clinical research, has announced a major second step toward full implementation of a multi-stakeholder shared information technology platform.
vTv Therapeutics, a clinical-stage biopharmaceutical company engaged in the discovery and development of new orally administered treatments for Alzheimer’s disease and diabetes, has announced the enrollment of the first patients in the company’s phase II LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential.
Veeva Systems has introduced the Veeva TMF Maturity Model, a complimentary consultative service designed to assess the state of a life sciences organization’s trial master file (TMF) strategy and provide a roadmap for improvement. The Veeva TMF Maturity Model gives practical, step-by-step guidance to help companies transform their TMF from a static archive into a strategic asset that can help increase the efficiency of clinical trials. It is available as a self-service online tool or as a more detailed, in-person evaluation with a seasoned subject matter expert.