Business and People August 2013

People

• ICON plc (Dublin, Ireland) announced the appointment of Neil McCullough, PhD, as Executive Vice President of Quality and Compliance and Corporate Training. In this role, McCullough will provide strategic direction for quality management, quality assurance, and corporate training across all ICON lines of business.

• CTI Clinical Trial and Consulting Services (Cincinnati, OH) announced the following new hires: Renee Torres, Biostatistician II; Roy Wells, Senior Auditor, Quality Assurance; Angela Bowens, Clinical Safety Scientist; Cynthia Fairbairn, Study Coordinator; Cheryl Chapman, Clinical Safety Associate; Michelle Clifford, Research Associate; and Chika Okere, Research Associate. The company also announced the following promotions: John Williams was promoted to Assistant Director, Clinical Monitoring; Allison Schroeder was promoted to Associate Manager, Marketing and Corporate Communications; Joseph Schroeder was promoted to Contract Specialist; David Flick was promoted to IT Support Analyst; and Michel Connor was promoted to Assistant Project Manager.

• Chiltern International Limited (Chiltern) (London, UK, and Wilmington, NC) announced the promotion of Alecia Barbee from Executive Director of Biometrics to VP of Global Biometrics. In this role, Barbee will have global oversight of data management, data programming, biostatistics, and e-clinical functions in Chiltern.

• CROnos Clinical Consulting, (Hamilton, NJ) announced that Pamela Keenan has joined the company as Vice President, Scientific Affairs.

• Neurovations (Napa, CA) announced the addition of Renée Bell as its Director of Clinical Research.

• Southern Research Institute (Birmingham, AL) announced that Arthur J. Tipton, PhD, has been selected by its board of directors to serve as President and CEO. Tipton replaces John A. Secrist, III, PhD, who served as President and CEO for seven years. Secrist announced his retirement earlier this year after 34 years of service at Southern Research.

• Clinical Research Advantage (CRA) (Tempe, AZ) announced the addition of Craig J. Smith, CPA, MBA, as the company's Chief Financial Officer.

• PHT Corporation (Boston, MA and Geneva, Switzerland) announced the addition of Steven Rosenberg to the company in the role of Chief Operating Officer.

Steve Rosenberg

• PSI CRO (Zug, Switzerland) announced the appointment of Andrea Cracraft as Director, Clinical Operations North America.

• goBalto Inc. (San Francisco, CA) announced its new Customer Success division, designed to nurture and expand customer relationships through consultative account management practices, and to ensure continuous customer enthusiasm. Ken McFarlane joins the goBalto team as Senior Director of Customer Success. Also joining the team is Ashley Davidson as Director of Customer Success.

• OmniComm Systems, Inc.. (Fort Lauderdale, FL) announced that Kuno van der Post, PhD, has been promoted to Senior Vice President of Business Development.

Alliances

• OmniComm Systems, Inc. (Fort Lauderdale, FL) and Reliable Lifesciences Consulting (RELICO) announced their new strategic partnership. The partnership will allow OmniComm to offer EDC project management and support, and add to their own European-based support services. It also will allow RELICO to offer study build and support services to its clients, as well as access to the intuitive EDC suite.

• The Association for the Accreditation of Human Research Protection Programs (AAHRPP) (Washington, DC and New York, NY) and the ViS Research Institute announced a strategic alliance to further protect research participants by providing easy access to information on the quality and standards of organizations that conduct clinical trials. ViS has developed an online analytics platform to streamline the feasibility assessment of research sites. Because of the alliance, ViS profiles of research sites will now include information on whether the site has earned AAHRPP accreditation.

Awards

• Greenphire, (King of Prussia, PA) provider of payment technologies for the clinical trials industry, announced three industry recognitions. The company's CEO, Sam Whitaker, has been selected as a finalist for the Ernst & Young Entrepreneur of the Year Awards 2013 in the Greater Philadelphia region. The company's CFO, John Samar, has been named as a finalist in the Philadelphia Business Journal's CFO of the Year Award program. In addition, Shawn Milochik, Vice President of Software Engineering, was awarded the Philadelphia Business Journal's Top IT Innovator Award.

Sam Whitaker

• Rho (Chapel Hill, NC) announced that CEOs Russell W. Helms, PhD, and Laura Helms Reece, DrPH, were named as finalists for the Ernst & Young Entrepreneur of the Year Award for the Southeastern United States.

John Samar

• Pharmaceutical Product Development (PPD) (Wilmington, NC) announced the Computerworld Honors Program has named PPD a 2013 Laureate. The annual awards celebrate visionary applications of information technology that promote positive social, economic, and educational change

• Quintiles (Research Triangle Park, NC) has received the 2013 Informatics Innovation Award for "Enterprise Data Integration" recognizing its efforts, through the Quintiles Infosario solution, to integrate both clinical research and healthcare data across numerous institutions and at a high scale.

• ClinTec International (Glasgow, Scotland) announced that Founder and CEO, Rabinder Buttar, PhD, won the "Female Entrepreneur of the Year" award at the Scottish Business Awards 2013.

Rabinder Buttar

Company News

• The Society for Clinical Data Management (Brussels, Belgium) hosted its first conference outside of the United States May 31 to June 1 in Mumbai, India. Over 150 expert professionals and industry leaders, representing 50 companies and seven countries, gathered around the Changing Landscape of Clinical Data Management.

• The Clinical Data Interchange Standards Consortium (CDISC) (Austin, TX) announced plans to implement CDISC SHARE. After a comprehensive proposal and evaluation process, SOA Software's Semantic Manager product was chosen as the SHARE technology platform by a selection committee consisting of CDISC leaders and volunteers, with substantial support from TransCelerate BioPharma Inc. SHARE, or Shared Health And Research Electronic Library, a cornerstone of the CDISC technical roadmap, will be a global electronic repository for developing, integrating, and accessing CDISC metadata standards in electronic format.

New Facilities

• Celerion (Lincoln, NE) announced the addition of a containment room at the Belfast, Northern Ireland, UK facility. The new containment room will allow Celerion to develop programs that require studies utilizing biologics, as well as vaccines with primary and secondary containment. The containment room is a modular facility comprising a negative pressure processing room which houses a Biosafety Level (BSL-2) cabinet. The addition of the room further enhances the current GMP licensed site by enabling the processing of live Class 2 and Class 3 biological products.

• TKL Research (Rochelle Park, NJ) is constructing a new clinical research facility in Fair Lawn, NJ, that will include a state-of-the-art, 30-bed, Phase I unit as well as multiple outpatient clinical examination rooms.

• Novotech (Sydney, Australia) has expanded its Asia reach into Hong Kong and the Philippines, building on its established network which already includes a presence in Singapore, South Korea, Taiwan, Thailand, India, and Malaysia.

• Quanticate (Boston, MA and Research Triangle Park, NC) announced the relocation of its US office with a move to North Carolina's Research Triangle Park. This expansion follows a number of partnerships that are being developed with Top 10 pharmaceutical companies to provide global functional support, particularly in the areas of biostatistics and statistical programming.

New Products

• ERT (Philadelphia, PA) announced enhancements to AVERT, its electronic suicide risk assessment system. Having already been used by over 32,000 clinical trial patients, AVERT is now available in both audio (phone) and visual (web/tablet) patient interfaces, offering greater flexibility to developers of new biopharmaceutical products.

• ArisGlobal (Stamford, CT) announced the availability of agCenter 3.1, a clinical research investigator site portal that facilitates and streamlines the communication and collaboration between sponsors and their clinical study sites. The investigator portal is the newest addition to ArisGlobal's Total Clinical™, a platform for clinical research that includes EDC, CTMS, ePRO, medical coding, trial disclosure, supply chain management, and safety reporting—all accessed via agWorld™, a central clinical portal.

• Biofficient Inc. (Boston, MA) announced the successful launch of its new platform to accelerate the outsourcing process for the biopharmaceutical drug development process. Biofficient.com, which hosts the platform, offers a streamlined solution to the arduous process of matching clinical trial sponsors' specific needs with a comprehensive database of contract services provided by a global list of industry vendors.

• CRF Health (Plymouth Meeting, PA) announced several enhancements to their TrialMax eCOA solutions. Updated features: ability to send SMS and e-mail reminders to patients across all TrialMax eCOA solutions to keep patients engaged; new TrialMax Slate study dashboard displaying the questionnaire status of all patient visits; on-demand access to study specific training; and patient and site user experience improvements.