Business and News Update January 2013

People

• Chiltern International Limited, (London, UK and Wilmington, NC) a global CRO, announced that Aize Smink and Linda Christmas have been promoted, coinciding with the appointment of Jim Esinhart, PhD, as CEO. Smink, previously Senior Executive VP, Global Clinical Development, has been named Chief Operating Officer. Christmas, formerly Senior Executive VP, Global Resourcing Solutions, has been named Chief Resourcing Officer. Chiltern also announced that Cedric Burg, PhD, and James Gunter have joined the company, bringing experience in clinical research to strengthen the global clinical development services.

• Phlexglobal (Malvern, PA) has appointed a new Chief Technology Officer to continue development of the company's technology innovations. Peter McNaney will be responsible for managing large-scale technology and service transformation engagements as well as delivering strategic consulting and ongoing technology service delivery to customers.

• The Patient-Centered Outcomes Research Institute (PCORI) (Washington, D.C.) has named Sue Sheridan, MBA, MIM, as Director of Patient Engagement. Sheridan, who served as PCORI's Deputy Director of Patient Engagement since February, will be responsible for the development and execution of PCORI's patient engagement strategy to bring the voices of patients, caregivers, and patient advocates to PCORI's research agenda.

• CTI Clinical Trial and Consulting Services (Cincinnati, OH) announced that Kathryn Wekselman, PhD, RN, has joined as Director, Regulatory and Scientific Affairs, and Tammy Dandrea, BS, PA, has joined as Assistant Director, Medical and Scientific Affairs.

• ProTrials Research, Inc. (Sunnyvale, CA) has added Diane Wong to its senior staff as Director of Quality Assurance. Most recently the Associate Director of Clinical Quality Assurance for South San Francisco's Janssen Alzheimer Immunotherapy Research & Development, Wong joins ProTrials with more than 15 years of industry experience in quality and regulatory compliance.

• Quorum Review IRB (Seattle, WA) has selected Courtney Scott, MBA, CIP, as its Northeast Corporate Business Development Representative, based in Cambridge, MA. Scott has worked for Quorum Review for seven years, most recently as an Institution Specialist. She brings customer service and clinical research experience to serve Quorum's clients in Northeast region.

• BBK Worldwide (Newton, MA) announced the hiring of Rebecca Panzer and Lindsay Court to the company's Client Services Department. Panzer and Court will contribute their knowledge and experience in managing day-to-day client team activities.

• INC Research, LLC (Raleigh, NC) announced the appointment of Robert Ryan, PhD, as Vice President, Regulatory Strategy, Consulting and Submissions. Ryan aims to provide global leadership to position INC Strategic Advisory Services as a market leader in regulatory consulting and submissions offerings.

• inVentiv Health, Inc. (Burlington, MA) announced organizational changes within its clinical group. Raymond Hill is joining the company as Executive Vice President of Clinical, and will be responsible for leading the company's clinical business segment, which includes early stage, Phase II-IV, and strategic resourcing.

Awards

• CRF Health, (Plymouth Meeting, PA) the developer of the TrialMax Suite of electronic Clinical Outcome Assessment Solutions (eCOA) for the life sciences industry, was named to the 2012 edition of the Deloitte's Technology Fast 500 for its proprietary intellectual technology. The TrialMax Suite of eCOA solutions enables the collection, management, and near real-time visibility of clinical research data reported directly from patients, clinical observers, and investigators.

• Covance Inc. (Princeton, NJ) announced the CEO Roundtable on Cancer accredited the company with the CEO Cancer Gold Standard, recognizing the organization's commitment to the health of its employees and their families. The CEO Cancer Gold Standard is a series of cancer-related recommendations developed by the CEO Roundtable on Cancer, a non-profit organization of cancer-fighting CEOs whose mission is to make continual progress toward the elimination of cancer as a personal disease and public health problem.

• OmniComm (Fort Lauderdale, FL) announced it ranked 286th on Deloitte's Technology Fast 500, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences, and clean technology companies in North America. OmniComm grew 265% during this period.

• Clinical Research Advantage (CRA) (Tempe, AZ) received top honors in this year's Best in Biz Awards, the only independent business awards program judged by members of the press and industry analysts. CRA received the Gold Award for Business Development Department of the Year. Casey Orvin, Vice President of Business Development, and Amanda Drake, Director of Business Development, were recognized for their achievements in helping the company grow.

Alliances

• Clinical Research Management, Inc. (ClinicalRM) (Hinckley, OH) announced it was awarded a US Army Medical Materiel Development Activity (USAMMDA) contract. With this contract, ClinicalRM will provide regulatory support personnel and may also provide equipment, supplies, facilities, transportations, tools, and materials necessary to support USAMMDA's mission.

Company News

• PCORI's (Boston, MA) Board of Governors has adopted 47 revised methodology standards to guide the conduct of patient-centered outcomes research as recommended by PCORI's Methodology Committee. A full narrative report, providing context for the standards, will be revised and published next spring.

• The Clinical Data Interchange Standards Consortium (CDISC) (Austin, TX) used the CDISC International Interchange to formally launch the Coalition for Accelerating Standards and Therapies (CFAST). It also marked the 10th anniversary of these CDISC Interchanges.

• WorldCare Clinical, (Boston, MA) a CRO focused on maximizing the precision and accuracy of independent assessments in clinical trials, has in collaboration with Sheela Agarwal, Massachusetts General Hospital, Division of Abdominal and Interventional Radiology, to publish a review article entitled "US FDA Draft Guidance Standard for Clinical Trial Imaging Endpoints: More Than Just Imaging?" in the December Issue of Biomarkers in Medicine.

• CDISC (Austin, TX) announced the launch of the inaugural CDISC Asia-Pacific Interchange to be held February 18-22, 2013, in Singapore. Singapore was chosen for its central location in this region, the epicenter of some of the most booming economies in the world. The core message of the CDISC 2013 Asia-Pacific Interchange is "Streamlining Global Research through Standards," and representatives from local Asia-Pacific ministries of health, pharmaceutical companies, clinical research organizations, technology service firms, and non-governmental organizations will be in attendance.

New Facilities

• ACM Global Central Laboratory (Rochester, NY) announced that it has relocated its laboratory facilities in York, England. The move to a larger facility is in response to growing client demand for ACM Global's clinical trials testing services throughout Europe, including Western and Eastern Europe, as well as South Africa and the Middle East.

New Products

• Cenduit, LLC (Durham, NC) has introduced a new study simulation and forecasting service that will enable clinical trial sites to better plan and control supplies for their patients. When integrated with Cenduit's interactive response technology (IRT) services, the new service aims to give sponsors confidence in their clinical supply chain.

• PharmaVigilant (Westborough, MA) announced the release of I-Accountability, a drug accountability system that aims to efficiently track and control drug inventory and randomization.