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Industry news focusing on the people and organizations who work in the clinical trials profession.
• Theorem Clinical Research (King of Prussia, PA) has appointed Brian Bollwage, JD, as Vice President of Global Regulatory Affairs.
• David Elder, formerly a senior official of the US Food and Drug Administration, has been appointed as a Vice President to PAREXEL Consulting's (Boston, MA) Strategic Compliance Services team.
• Premier Research Group (Philadelphia, PA) has hired several new people including Hua Gong to the position of Executive Director of Medical Diagnostics. In this role, Gong will be responsible for overseeing the in vitro diagnostics business within the company. Susan C. Stansfield, PhD, has been named Executive Vice President, Clinical Development, where she will have global responsibility for leading and developing the company's clinical trial management services provided to the biopharmaceutical industry.
• CTI Clinical Trial and Consulting Services (Cincinnati, OH) has named Melanie A. Bruno, PhD, Vice President of Clinical Trial Operations.
• Cetero Research (Cary, NC) has made two new appointments to its senior management team. Michael C. Fillios was named Chief Administrative Officer and David Coggin was named Vice President, Biometrics.
• Marken (London, UK) announced that Steve Roese was named Vice President of Marken's Global Quality Assurance organization. Andrea Zobel, PhD, has also joined the company in the new role of Senior Director, CTD Operations.
• Rick Ward has started as Vice President of Sales and Jerold Grupp as Vice President of Quality, both at Greenphire (King of Prussia, PA).
az magazine named Clinical Research Advantage as a top workplace for women. From left to right: Ange-Lisa Ashbeck, Director of Training, Michele Aguirre, Director of Regulatory and QA, and Amanda Drake, Director of Business Development.
• Impact Corelab (Sacramento, CA) has elected two new members to its board of directors, Vipin Bansal, MD, currently Chair of the Radiological Associates of Sacramento (RAS) Finance Committee, and Mark Leibenhaut, MD, FACR, an Executive Committee Member for RAS.
• The Almac Board (Craigavon, UK) has appointed Kevin Stephens to the executive position of Finance Director.
• Clinigen Group (Burton-on-Trent, UK) has appointed Shaun Chilton as Chief Operating Officer of the group's services division. He will have overall leadership responsibility for Clinigen's services division, incorporating two of Clinigen's operations: Keats Healthcare, a clinical trial supply business acquired in 2010; and Clinigen GAP, a specialist provider of early- and late-lifecycle prescription drugs.
• Exco InTouch (Nottingham, UK) has hired Mark Brincat as Product Development Director. The new appointment will see Brincat lead the strategy and development of the company's range of patient-centric services and mHealth solutions
• CDISC (Austin, TX) Board of Directors has elected three members for a three-year term. Returning to the board are C. David Hardison, PhD, and Pierre-Yves Lastic, PhD, joined by new Board Member Robert Goodwin.
ICON (Dublin, Ireland) announced the appointment of Brendan Buckley and Nicholas Alp, PhD, to the company's Global Scientific Council.
• DAC Patient Recruitment Services (Dallas, TX) welcomes Jennifer Lambert to its project operations team as a Project Manager.
• Horizon Discovery (Cambridge, UK) has appointed Eric Rhodes as Chief Technical Officer, Gene Targeting.
• inVentiv Health (Burlington, MA) has hired Chuck Shea as Executive Vice President of inVentiv Health Commercial.
• Matt Grace has joined Myoderm (Norristown, PA) as Director, International Supply Services.
• Medidata Solutions (New York, NY) has expanded its accreditation program for services partners to include seven additional Medidata products,and are available through the Medidata Partner Program.
• ICON (Dublin, Ireland) announced that is has signed a strategic partnership with Shire Specialty Pharmaceuticals (Dublin, Ireland) to serve as the sole global provider of central laboratory services and one of two strategic partners for clinical development services.
• Greenphire (Philadelphia, PA) has formed an exclusive strategic partnership with the clinical trials division of Merge Healthcare (Chicago, IL) to offer integrated functionality between Merge's EDC technology and Greenphire's eClinicalGPS site and vendor payment management technology.
• Institutional Review Board Services (IRB Services) (Aurora, Ontario) has been awarded full accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). IRB Services is the first fully independent, unaffiliated Canadian-based research ethics committee to earn accreditation from AAHRPP.
• Clinical Research Advantage (Tempe, AZ) has been selected among az magazine's top 25 workplaces for women.
• Ian Smith, MD, Founder and Global Medical Director of Synexus (Lancashire, UK), was awarded an MBE "for services to Health Research" in the Queen's New Years honors list.
• The Avoca Group (Princeton, NJ) has formed the Quality Consortium, a pharmaceutical industry consortium focused on quality management.
• CDISC (Round Rock, TX) was notified by the US Internal Revenue Service that it is approved as a 501(c)(3) organization, recognizing CDISC as a charitable organization retroactive to May 2011. While CDISC has been a 501(c) tax-exempt, non-profit organization since February 2000, this new status offers added benefits to assist CDISC in achieving its mission, vision, and goals.
• Quintiles (Research Triangle Park, NC) announced the formation of its new Digital Patient unit.
• goBalto (San Francisco, CA), developer of new generation web-based clinical research solutions, successfully completed a FDA 21 CFR Part 11 compliance audit of its goBalto Tracker software-as-a-service clinical trials application.
• The Tufts Center for the Study of Drug Development (Boston, MA) announced that it has established the first global benchmark for clinical research associate (CRA) workload and utilization, giving managers insights into improving CRA effectiveness and efficiency.
• Industry Standard Research (Cary, NC) announced the release of a new report focused on the impact comparative effectiveness research does and will have on formulary placement. ISR also released two new reports focused on the Biosimilar industry, "US Payers and Biosimilar Formulary Placement" and "Biosimilars: A View from the Pharmacy."
• TAKE Solutions (Chennai, India) announced the availability of PharmaReady™ 5.0, a web-based regulatory compliance solution suite for life science organizations to ensure faster approvals for their new products.
• StudyManager (Seattle, WA) has added a patient registration interface to its Reveal CTMS software, enabling research sites, academic medical centers, and health systems to integrate Reveal with a variety of electronic health record systems.
• Almac (Craigavon, UK) has opened a new £3m ($4,691,244) building at its Craigavon, UK headquarters. Around 150 staff who work for Almac's Clinical Services Business Unit have also moved to the new 30,000 sq ft building to consolidate its services.
• Building a global presence, CoreLab Partners (Princeton, NJ) has announced the opening of an office in Tokyo, Japan under the wholly owned subsidiary of CoreLab Partners Japan.