Business and News Update January 2012

People

• Datatrial (Newcastle upon Tyne, UK), a boutique clinical data management organization, has announced Chief Operating Officer Emma Banks, PhD, as its new CEO, replacing Adam Black. Black will move from CEO to Non-Executive Director of the company.

Emma Banks, PhD

• Premier Research Group (London, UK) has appointed Tilly Beazeley to the position of Senior Director, Business Development, covering the United Kingdom and Scandinavia.

Tilly Beazeley

• With more than 25 years of experience in key management positions with multinational and domestic firms, Kaushik Desai has accepted a position with DIA (Mumbai, India) as Director of DIA India.

Kaushik Desai

• Robert Soto has been hired as Vice President, Sales and Marketing, at Stiris Research (London, Ontario), where he will be responsible for enhancing the Stiris brand through its sales and marketing efforts.

Robert Soto

• CTI Clinical Trial and Consulting Services (Cincinnati, OH) had welcomed John R. Edwards, MD, as Medical Director, to its team. Edwards brings with him extensive clinical experience in hematology, oncology, and stem cell therapy.

• Under its new name PPH plus, PharmaProjekthaus, has made several changes to its team. Johanna Schenk, MD, co-founder of PharmaProjekthaus GmbH & Co. KG, has taken on the role of Managing Director and Chief Operating Officer. Peter Klöpel, MD, Director of Consulting Services, and Petra Weissenberger, MD, Head of Medical Services, form the rest of the company's management team.

• Novella Clinical (Research Triangle Park, NC) has appointed Catherine A. Tyner as Executive Director, Oversight Group Management.

• With over 15 years of extensive experience in selection and integration of cognitive testing into drug development programs, John Harrison, PhD, has accepted an appointment as Scientific Consultant at CRF Health (Plymouth Meeting, PA).

• Advanced Clinical (Deerfield, IL) has hired Ami DeBoer as Director of Recruiting.

• The European Medicines Agency's (London, UK) Management Board formally appointed Guido Rasi as the new Executive Director of the Agency.

• Synexus (Lancashire, UK) has announced that Alan Pilgrim will join the board as Chairman. Alan has extensive healthcare experience, having recently retired as Group Chief Executive Officer of Alliance Medical.

• ICON (Dublin, Ireland) has appointed Colin Stanley as President of DOCS, the company's global resourcing division. Stanley succeeds Bill Taaffe as President following his retirement earlier this year.

Alliances

• Medidata Solutions (New York, NY) announced that its electronic data capture and clinical data management solution Medidata Rave has been selected by OptiNose US (Yardley, PA) to capture clinical trial data across all studies. OptiNose US has also selected BioClinica's (Newtown, PA) Trident IWR, Optimizer clinical supplies forecasting, and imaging core lab services for use in a series of clinical trials including several Phase III studies.

• BRANY (Lake Success, NY) has licensed its proprietary SMART (Study Management and Revenue Tracking) system to Tech Software, Inc. (Melville, NY).

• Almac (Craigavon, Northern Ireland) and Queen's University, Belfast (Belfast, UK) have made an investment of £4.4 million ($6.96 million) in a unique academic-business collaboration to help develop improved tests for diagnosing and treating prostate, ovarian, and breast cancer.

• Virtual Radiologic (vRad) (Minneapolis, MN) has formed a premier radiology partnership with ICON Medical Imaging (Dublin, Ireland). ICON provides medical imaging-based product development services to the pharmaceutical, biotechnology, and medical device industries, and ICON will have access to vRad's subspecialty knowledge and be able to obtain interpretations provided by vRad's radiologists.

Awards

• Competing against 350 companies, Quintiles (Research Triangle Park, NC) has been named one of 24 companies listed in the first-ever "World's Best Multinational Workplaces" list from the Great Place to Work Institute. In addition, Quintiles' digital efforts to bridge the gaps between clinical research, patients, and clinical trial participants have been recognized in the form of two International Davey Awards and a Web Health Award. Quintiles was also named fourth in the InformationWeek 500 technology innovators rankings for its Quintiles INFOSARIO platform.

Quintiles was honored as a top multinational employer by the Great Place to Work Institute. Quintiles staff were recognized at a gala in New York City. The 25 companies chosen were selected from more than 350 multinational companies in 45 countries.

• The American Diabetes Association honored Integrium Clinical Research (Tustin, CA) at its 16th annual gala that recognized leaders and pioneering researchers in diabetes.

• Synteract (San Diego, CA) has been listed on Inc. Magazine's fifth annual Inc. 500|5000, a ranking of the nation's fastest-growing private companies.

Company News

• Quotient Clinical (Nottingham, UK) announced that absolute bioavailability data from an ivMicrotracer™ study has been used to support a submission for regulatory drug approval. The study was performed on behalf of Bristol Myers Squibb in support of Onglyza™ (saxagliptin), a new medicine for Type 2 diabetes.

• CRF Health's (Plymouth Meeting, PA) TrialMax® has become the first ePRO system to complete its medical device registration.

• Celerion's (Belfast, Northern Ireland) clinical research operations have received authorization from the Medicines and Healthcare product Regulatory Agency to have importation of IMPs added to their manufacturing (MIA(IMP)) license.

• The European Medicines Agency (Brussels, Belgium) has carried out a consultation on increased transparency and access to information included in companies' applications for marketing authorization.

• StudyManager (Seattle, WA) announced that BalanceSense (Celebration, FL) awarded StudyManager an eight-site, Phase II army contract to implement Evolve CTMS and EDC.

• Radiological Associates of Sacramento (Sacramento, CA) and Radiant Sage (Belmont, MA) have launched Impact Corelab, Inc. (Sacramento, CA), a firm that provides imaging core lab services specializing in oncology and neurology clinical trials for drug and device sponsors and clinical research organizations wanting to outsource without compromising the need for transparency and control.

• ClinPharm Consulting (Research Triangle Park, NC)is offering new services including PK sample schedule evaluation, a PK help desk or hotline that allows "on call" access to pharmacokineticists and clinical pharmacology consultants, and a virtual clinical pharmacology/PK group, among others.

New Facilities

• Chiltern International (London, UK) has opened a new office in Bannockburn, IL.

• PharmaNet Development Group announced that its subsidiary, PharmaNet Canada (Quebec, Canada), and The Research Institute of McGill University Health Center (Montreal, Canada) have signed a letter of intent to jointly form, manage, and operate the first in-hospital translational medicine unit for the conduct of Phase I-IIa clinical studies in Canada. The state-of-the-art facility will be located at the Montreal General Hospital and is expected to commence operation in 2012.

Products

• MedNet Solutions (Minnetonka, MN) has released the newest version of iMedNet™ EDC, the company's new eClinical solution that allows non-technical research personnel to quickly and affordably build and manage their own clinical studies. The company has also officially launched its iMedNet CRO Partner Program.

• Oracle Health Sciences (Redwood Shores, CA) has announced the availability of Oracle Health Sciences OutcomeLogix On Demand 3.0, a web-based, scalable data collection system that enables life science companies and contract research organizations to efficiently capture accurate therapy outcome information from healthcare providers and patients in late-stage studies. New features include increased scalability to support data collection, improved and a user-friendly interface that walks users through the data collection process, and updated prompting tools that engage patients and promote compliance by encouraging them to remain involved in the study.

• ACM Global Central Lab (Rochester, NY) has announced the launch of a liquid nitrogen based dry-vapor shipping solution in collaboration with Cryoport, Inc. (San Diego, CA).