Business and News Update July 2012

People

• Theorem Clinical Research (King of Prussia, PA), a full-service contract research organization that provides core clinical research and development services, has named Brian Mooney Senior Vice President of Global Clinical Development. Patricia Bland has been introduced as Executive Director of Corporate Development.

Eric S. Perlman

• WorldCare Clinical, LLC (Boston, MA) announced that Kenneth O'Brien has joined the organization as Executive Director of Quality and Regulatory Affairs. O'Brien will be responsible for all quality assurance and regulatory affairs operations, including ensuring regulatory compliance and computer system validation processes.

Patricia Bland

• The American College of Radiology (ACR) (Reston, VA) has named medical imaging contract-research veteran Eric S. Perlman, MD, Chief Medical Officer of ACR Image Metrix™. Image Metrix is an imaging contract CRO and for-profit subsidiary of the ACR. Perlman has more than two decades of experience in radiology.

Kenneth O’Brien

• Frederick Young, PhD, has joined the Infectious Diseases leadership team of INC Research, LLC (Raleigh, NC) as Vice President, Infectious Diseases. Young will lead the company's infectious diseases therapeutic unit globally.

Brian Mooney

• Idis (Princeton, NJ) announced the addition of two industry veterans to the company's leadership team. Sue Barrowcliffe joined Idis as Global Director of Regulatory and Medical Strategy, while Jeff Oliva was appointed Senior Vice President of Global Business Development.

• Vectura Group (Chippenham, UK), which specializes in developing therapies, principally for the treatment of respiratory diseases, announced that Trevor Phillips, BSc, PhD, MBA, has joined the company's board.

• ACM Global Central Lab (York, UK) has announced that Isabel Struik has joined the executive management team as Head of Business Development in Europe. Struik brings vast experience in the clinical research arena having worked in the clinical trials industry for more than 13 years and in all major therapeutic areas.

• CTI Clinical Trial and Consulting Services (Cincinnati, OH) announced that Chyon-Hwa Yeh has joined as a biostatistician. Yeh brings with her over 20 years of experience working for Procter & Gamble (P&G). During her time at P&G, she served as both project statistician and statistical function leader for many different areas, such as gastroenterology, cardiology, pet care nutrition, and health technology.

Alliances

• BioClinica (Newtown, PA) is partnering with NextDocs (King of Prussia, PA), a leading global provider of Microsoft SharePoint-based compliance solutions to life sciences organizations, to deliver solutions that provide easier access to clinical trial information and decrease the timeline for FDA submissions.

• Medidata Solutions (New York, NY) worked with R&D and technical services institute RTI International to upgrade the technology it uses to provide statistical and data coordinating services for National Institutes of Health-funded research.

• Quintiles (Research Triangle Park, NC) and Archimedes (San Francisco, CA) have collaborated to co-promote clinical and commercial solutions for biopharmaceutical companies to reduce the time and expense associated with developing and marketing novel therapies. Quintiles will incorporate Archimedes' ARCHeS Innovator, and modeling consulting solutions, into its existing offerings. ARCHeS Innovator enables users to run clinically realistic virtual trials on any population and create compelling evidence.

• Oracle (Redwood Shores, CA) has acquired Clear-Trial (Chicago, IL), a leading provider of cloud-based clinical trial operations and analytics products that help make the planning, sourcing, and tracking of clinical projects and financial performance faster and more accurate. The combination of the two companies is expected to deliver a comprehensive closed-loop clinical trial management offering from planning to payment.

• INC Research, LLC (Raleigh, NC), a therapeutically focused CRO has entered into a functional service provider alliance with Astellas Pharma Global Development, Inc. (Northbrook, IL), to drive global consistency, save time, and reduce costs for multiple clinical development programs across several therapeutic areas. In an initial three-year agreement, INC Research will deliver key functional services, including clinical monitoring, clinical data management, trial master file management, site start-up, and study feasibility activities.

• Frontage (Exton, PA), a global CRO, will develop clinical trial supplies with AtheroNova Inc., a biotech company focused on the research and development of compounds to regress atherosclerotic plaque. Under the agreement, Frontage will commence work on the formulation, compounding, and tabletization of the company's AHRO-001 product in advance of the upcoming Phase I human clinical studies. AHRO-001 is AtheroNova's first novel application for the treatment and prevention of atherosclerosis.

• Covance, Inc. (Princeton, NJ), a provider of drug development services, and BML, Inc., a leading Japanese laboratory testing company, announced the expansion of the Covance-BML clinical trial laboratory in Kawagoe City, Saitama Prefecture, Japan to enhance the capacity and capabilities in the region. The companies, which opened the lab together in 2010 as part of a five-year agreement, will launch several new expansion-related services.

• PRA (Raleigh, NC), a CRO, announced a new agreement with Amgen for a series of Phase III studies to develop several biosimilar drugs on a worldwide basis. PRA will serve as the sole provider of CRO services for these studies. The agreement is intended to govern the entire anticipated scope of Amgen's global biosimilar portfolio.

• Synexus (Manchester, UK) has strengthened its leadership position in Poland with the acquisition of Osteomed. Based in Warsaw, Medical Centre Osteomed is an FDA audited clinical research company, whose client list includes many of the world's leading pharmaceutical companies and CROs.

• NSF-DBA, (Bangalore, India) an NSF International Health Sciences Company with more than 25 years of experience in the pharmaceutical industry, has signed a collaborative agreement with Semler Research Center Pvt, Ltd. of Bangalore to expand pharmaceutical training, auditing, consulting, and testing services throughout India.

New Products

• Forte Research Systems (Madison, WI) has launched the newest member of the Allegro® product line: Allegro CTMS@Network™ . The new product aims to improve site selection, study start-up project management, and visibility into study conduct across multiple sites.

• The Clinical Data Interchange Standards Consortium (CDISC) (Round Rock, TX) has released the first iteration of a protocol representation "toolkit" for clinical research. The kit is designed to make it easy for authors of a research plan or protocol to reap the benefits of the protocol representation model, which has been developed over the past decade by global clinical research experts from academia, industry, and government.

Awards

• Clinical Data Interchange Standards Consortium (CDISC) (Round Rock, TX) won two recent Global R&D is Innovation Awards at Genzyme/Sanofi. GetSMART, which involved implementation of a number of CDISC standards, won in the Internal Business Value category. RegistryNXT!, which is based on the collaborative BRIDG model, won in the Value to Patients category.

• Clinical Research Advantage (Tempe, AZ), a community-based network of clinical trial sites, has been named Best Clinical Trial Site Network by the World Vaccine Congress. The award was announced at the 2012 Vaccine Industry Excellence Awards in Washington, DC. The VIE Awards celebrate the leaders, innovators, and pioneers in the vaccine industry. Clinical Research Advantage also received second place for Best Clinical Trial Site.

Company News

• Marken (Middlesex, UK) has completed all the commissioning work for its new operational hub in Feltham, UK. The new location is within four miles of Heathrow Airport and part of the North Feltham Trading Estate Industrial Centre.

• LabConnect, LLC (Seattle, WA), a provider of global central laboratory services for the biopharmaceutical industry, has released its proprietary clinical trial sample tracking and management service: SampleGISTICS™ . The system provides web-based, real-time sample tracking including collection, shipment, and receipt at any laboratory or location worldwide.

• Oracle (Redwood Shores, CA) has released the newest version of its Health Sciences Clinical Development Analytics. The application includes new functionality that expands visibility into clinical programs and studies, improves the quality and timeliness of clinical trial data, and helps to simplify and prioritize the rapidly expanding responsibilities of study managers, clinical data managers, and site monitors.

• In response to regulators' increasing emphasis on patient centered data, including patient-, clinician-, and observer-reported outcomes (PRO, ClinRO, and ObsRO), invivodata (Pittsburgh, PA) is integrating its consulting division—formerly PRO Consulting™ —into its portfolio of clinical outcome assessment consulting services. The new service will be called invivodata Consulting and will complement and integrate with the company's eSolutions and regulatory services.

• Mytrus (San Francisco, CA), an innovative clinical technology and services company for medical and pharmaceutical research, debuted its iPad application explaining informed consent prior to clinical trial patient enrollment. Using animation and other visual imagery, the application condenses the complex and critical disclosure information required at the start of a clinical trial into an easy-to-understand, digitized format.

• Chiltern International Limited (London, UK), a global CRO, announced the establishment of a new legal entity in Taiwan. Umakanta Sahoo, Chiltern Executive Director, Asia Pacific and Managing Director, India, will be leading the effort in Taiwan.

• ACM Global Central Lab (Rochester, NY) has advanced its hybrid central lab model in Mumbai, India with a state-of-the art operational facility dedicated to managing clinical trials testing in India and provides study support throughout Asia Pacific. ACM Global oversees the full complement of study support to keep clinical trials on schedule and on budget, including kit building, shipping logistics, project management, data management, and site support.

• Moffitt Cancer Center (Tampa, FL) has gone live with its next-generation health and research informatics platform, built on Oracle Health Sciences solutions. In early deployment, the new platform enables Moffitt to accelerate clinical trial patient recruitment and advance personalized medicine. The new informatics environment supports Moffitt's Total Cancer Care™ program by generating new intelligence from existing systems.

• Industry Standard Research (Cary, NC) announced the availability of a new report titled The State of Patient Recruitment in Clinical Trials, which provides sponsors and service providers with valuable insight into the activities and strategies that drive and restrict patient recruitment in clinical trials.

New Products Announced at DIA 2012

• iGATE (Fremont, CA) announces its Research Accelerator platform for the life sciences, an end-to-end management solution for R&D that integrates clinical information management technology and business outcomes-based methodology for informed decision-making in R&D.

• Oracle Health Sciences (Redwood Shores, CA) announced the latest version of its Translational Research Center, a platform that enables secondary use of electronic health records, administrative data, and omics data to help accelerate biomarker identification for drug discovery, clinical development, and translational research. This new release integrates genomic visualization tools that provide holistic views of multiple omics data modalities to enable systems biology-based approaches essential for understanding disease.

• Trifecta (Doylestown, PA) introduced InvestigatorSpace.com, designed to give clinical trial sponsors and sites clinical training capabilities for site operations.The web-based application tracks, validates, and reports investigator training activity through one interface.

• OpenQ (Charlottesville, VA) introduced OpenQ SafeGuard™ , a social enterprise compliance suite for managing social compliance risk. This patent-pending technology collects activity feeds, posts, and documents from social platforms and other enterprise interactions, to proactively identify and classify business and compliance risk. An intuitive interface helps manage compliance cases with classification of risk level according to industry driven and company-defined priorities.

• Y-Prime Technologies (Malvern, PA) has expanded its suite of eClinical software solutions with Prime Publisher™ , a concatenation tool designed to streamline the content review process and combines multiple data forms into a single, navigable format. Prime Publisher simplifies processes such as reviewing large sections of the eCTD by combining them in a single document.

• Merge Healthcare (Chicago, IL) released Merge eClinical OS, a new clinical trial operating solution that provides end-to-end study support for trials of all sizes. As a single, web-based solution, it has the flexibility to support trials in any phase, and capture any type of data, from any source, over any modality. Merge eClinical OS also has the scalability to grow if a trial increases in size, number or complexity. Merge eClinical OS provides a complete menu of clinical trial capabilities that can be mixed and matched to build a solid foundation for each trial environment.

• OmniComm (Fort Lauderdale, FL) announced a new level of integration with PharmaPros that provides OmniComm customers with a solution offering next-generation CTMS capabilities for mid-sized organizations interested in a flexible, SaaS solution for clinical trials management. This new integrated solution provides capabilities for site management and monitoring, budget tracking and management, eTMF/document tracking, and metrics portal and real-time Reporting.

• BBK Worldwide (Newton, MA) launched shop.BBKWorldwide.com, an online resource where clinical research professionals can go to learn about, and purchase, a full range of patient recruitment products and services. The website not only redefines the purchasing process by fostering more timely and informed decisions, but it redefines the audience of purchasers to include those looking for quick, standalone solutions. Clinical trial sponsors who previously may not have considered purchasing patient recruitment services now have an affordable and scalable way to do so. In addition to time-tested full-service solutions, the site features a range of recent innovations that include: Ready. Set. Go. Card℠ —a quick and convenient way to provide global study reimbursements; Clinical Study Notifier℠ —a notification service that alerts patients to clinical trials; eBinder: Study iPads® —a communication platform that makes it easy to manage documents, data and study personnel across multiple sites, clinical teams, and continents.

• Comprehend Systems (Palo Alto, CA) has made its access to comprehensive data analytics, visualizations, and reports with Comprehend Clinical available through the cloud. With this new delivery option, clinical research teams can make Comprehend Clinical seamlessly available to end users, enabling data analysis across multiple studies, contract research organizations, or clinical data collection systems, without any changes to internal IT infrastructure or data center.

• Medical Research Network (MRN) (Buckinghamshire, UK), which offers home trial and site nurse support as well as bespoke recruitment and retention services, has unveiled its new patient scheduling tool to manage, report, and track clinical trial projects in real time. MRN-SMART incorporates a digital pen data capture facility. When MRN's nurses visit patients in the home they can complete their records forms as usual however now data is now also automatically stored electronically on a central network which provides automatic tracking, enhanced visibility of trial data, and increased security.

• PharmaNet/i3 (Princeton, NJ), announced a major new release of the PharmaNet/i3 Interactive Response Technologies (IRT) clinical trial randomization and supply management system. The new release expands capabilities by providing a wide array of configurable functionality for both the web and telephone. Offered via a Software as a Service delivery model, the new release enables sponsors to realize comprehensive randomization and supply management solutions for their trials using configurable, pre-validated software components.