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Industry news focusing on the people and organizations who work in the clinical trials profession.
• Quanticate, (London, UK and Cambridge, MA) a global data-focused clinical research organization, announced the addition of Sally Du Toit as Vice President of Pharmacovigilance and Chris Cramer as Vice President of Clinical Data Management to their management team.
• SAFE-BioPharma (Fort Lee, NJ) named Peter Alterman, PhD, Chief Operating Officer of SAFE-BioPharma Association, the strategic, non-profit collaboration responsible for the global digital identity and digital signature standard used in the life science and healthcare sectors.
• IMARC Research, (Cleveland, OH) a clinical monitoring firm, announced the addition of seven new clinical research associates and one member of its business staff. The seven new CRAs are: Mary L. Lewis, BS, MT-ASCP; Virginia A. Mina, RN, CCDS, CEPS; Janet M. Gagnon-Yerkie, LVT, LAT, MBA; Tani Martin, RN, BSN, CCRC; Marcy B. McClain, MHA; Rachel Silver, BSE; and Shawn Kennedy, MA. IMARC also announced the appointment of Christopher Roach to its business department.
• OmniComm Systems, Inc. (Fort Lauderdale, FL) announced Thomas Vickers has been appointed Chief Financial Officer. Vickers was Vice President of Finance for the company and joined OmniComm in October 2011.
• Ariana Pharma, (Paris, France and Cambridge, MA) a provider of non-statistical clinical data analysis technology across life science industries including FDA, announced that it has appointed Mariana Kuras, PhD, as Chief Technology Officer.
• Clinical Research Advantage (CRA), (Tempe, AZ) an integrated site network in the clinical trials industry, announced the addition of Joanne Mashburn as Vice President of Quality Assurance. Mashburn will be responsible for the overall planning and implementation of quality assurance initiatives within CRA's 34 clinical research sites in Arizona, California, Colorado, Indiana, Iowa, Nebraska, and Nevada.
• Y-Prime Technologies, LLC, (Malvern, PA) an eClinical products and life sciences consulting services company, has expanded its international operations in Europe and has named Jeanette Anne Greef as Senior Business Analyst in the UK office.
• INC Research (Raleigh, NC) appointed Neil Ferguson as Executive Vice President, Business Development. He has global responsibility for the company's business development, marketing, proposals, and strategic alliance development, providing strategic leadership to drive the company's growth plans.
• Clinical Trial and Consulting Services (Cincinnati, OH) announced the hiring of Kathryn Wekselman, PhD, RN, as Director, Regulatory and Scientific Affairs, and Tammy Dandrea, BS, PA, as Assistant Director, Medical and Scientific Affairs.
• CGIRB (Research Triangle Park, NC) announced the promotion of Dawn Pope to Chief Operating Officer. In her new position, Pope will provide leadership and direction for the overall operations of the company, planning and coordinating the development of strategic objectives and goals.
• BioClinica, Inc. (Newtown, PA) announced that Luitpold Pharmaceuticals, a company in the development and marketing of drugs and medical devices, will use BioClinica's express electronic data capture system for multiple upcoming clinical trials.
• The Clinical Data Interchange Standards Consortium and Critical Path Institute (Austin, TX) announced the launch of the Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year.
• IMS Health (Parsippany, NJ) has signed a collaboration agreement with Health Intelligence Company LLC (HIC), which operates as Blue Health Intelligence, to leverage HIC's secure healthcare claims database in IMS solutions, enabling biopharmaceutical organizations to advance the delivery of high-quality, cost-efficient care.
• BioClinica Inc. (Newtown, PA) announced that Isis Pharmaceuticals will expand its current use of BioClinica's Express Electronic Data Capture solution to several upcoming trials.
• OmniComm Systems, Inc. (Fort Lauderdale, FL) announced a new enterprise agreement with the Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) for the use of OmniComm's TrialMaster Suite® of eClinical applications for all CORRONA registry studies.
• Comprehensive Clinical Development (Miramar, FL) announced its recent designation as a Quintiles Prime Site, a distinction that gives Comprehensive an enhanced role in global clinical research and testing of new and more effective medicines.
• Y-Prime LLC, (Malvern, PA) an enterprise consulting and eClinical products company, has established a systems integration partnership with Veeva Systems, a provider of cloud-based business solutions for the global life sciences industry.
• Nextrials, Inc. (San Ramon and Los Altos, CA) announced a partnership with InClin, a specialized clinical research organization conducting Phase I-IV studies for the pharmaceutical, biotechnology, and medical device industries. With this partnership, researchers can take advantage of each company's strengths by linking Nextrials' Prism® , a clinical trial data management platform, with InClin's services to accelerate study starts and lower drug development costs.
• Clinical Research Management, (Hinckley, OH) a full-service contract research organization providing services for basic and applied research, clinical trials, and regulatory support, was awarded the prestigious NorthCoast 99 award for building and maintaining a great place to work in Northeast Ohio.
• OmniComm Systems, Inc. (Fort Lauderdale, FL) announced that its TrialMaster Study Data Tabulation Model Export Utility has been chosen by the Society of Clinical Data Management as a finalist for its 2012 Data Driven Innovation Award.
• Clinical Ink (Winston-Salem, NC) announced that their eSource solution, SureSource, was recognized by The Society of Clinical Data Management as the winner of the 2012 Data Driven Innovation Award.
• Clinical Site Services (CSS), (Glen Burnie, MD) a company in patient enrollment solutions for the clinical research industry, announced the launch of its redesigned website www.ClinicalSiteServices.com. The new website aims to provide details for sponsor companies, CROs, and investigative sites who are seeking data on CSS's offerings and experience, including case studies, a creative portfolio, and a summary of services.
• Theorum Clinical Research (King of Prussia, PA) released a site-level reference booklet that highlights qualifications, regulatory/EC, informed consent process, CIP compliance, resources, training, device accountability, documentation, and safety reporting for clinical research sites.
• Quintiles (Research Triangle Park, NC) ranks sixth in this year's InformationWeek 500, a list of the top technology innovators in the United States. The driving factor behind this year's InformationWeek 500 ranking was Quintiles' collaboration with Eli Lilly on an IT-enabled project to re-engineer the way clinical trials are planned and designed.
• Celerion (Lincoln, NE) announced that it has been awarded full accreditation by the Association for the Accreditation Human Research Protection Programs (AAHRPP). Celerion's clinical facilities in Lincoln, NE; Neptune, NJ; and Phoenix, AZ, achieved this milestone.
• Vetter (Chicago, IL and Ravensburg, Germany) reported that its Development Service doubled its revenues over the last five years, due to increased customer demand for support on complex biologics.
Theorum Clinical Research (King of Prussia, PA) has relocated its headquarters 1.5 miles from the original site in King of Prussia, PA, where the company has been located for the past 10 years. The new location will provide staff a spacious work environment and enhance the company's flexibility and capabilities to provide clinical research and development services for its clients.
• ERT, (Philadelphia, PA) a global provider of health outcomes, announced the launch of a clinical research workflow technology designed to streamline data collection, analysis, and processing in clinical trials. The new offering, which comprises the EXPERT3 workflow platform and MyStudyPortal3 reporting engine, can simultaneously process health outcomes data across cardiac safety, clinical outcome assessment (COA/ePRO), and respiratory studies.
• Critical Path Institute and CDISC (Tucson, AZ) announced the availability of a new tool to help combat tuberculosis (TB)—a persistent disease resulting in 1.7 million deaths globally each year. The new tool—a standardized way to report research data—is critical for advancing new TB drug regimens.
• Janssen Scientific Affairs LLC (Titusville, NJ) announced the launch of JanssenMD, a new scientific resource for US healthcare professionals seeking instant access to current information about Janssen products marketed in the United States.