Business and People: February 2013


Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-02-01-2013
Volume 22
Issue 2

Options have emerged that make DIY EDC technology more accessible to smaller organizations.


INC Research, LLC, (Raleigh, NC), a therapeutically focused global clinical research organization announced the appointment of Sal Chiovari as its new Chief Information Officer. Chiovari will lead the company's worldwide information technology initiatives, including the development of new information systems architectures and strategic plans aimed at improving efficiency for clinical development programs.

CTI Clinical Trial and Consulting Services (Cincinnati, OH) announced the hiring of Ryan Bodle as Senior Accountant and Elaine Moorman as Study Manager. CTI also announced the promotion of Meredith Dees to Regulatory Specialist II, Kristen Cooney to Associate Study Manager, Theresa Crouch to Senior Regulatory Specialist, Jeff Smith to Senior Research Associate, and Joe Schroeder to Senior Research Associate.

Novella Clinical (Research Triangle Park, NC) announced an expanded business development team with the addition of three Directors of Client Service: Pamela Kennedy, RN, Fabio Mariano, and Matthew O'Rourke.

DIA (Horsham, PA) appointed Bayard Gardineer III as Director of Finance/Chief Financial Officer. DIA also announced that Jytte Lyngvig, former CEO of the Danish Medicines Agency, has been appointed Director for DIA Europe.

The Almac Group's (Souderton, PA) Clinical Technologies business unit announced that Charlie Morris has joined the company as Vice President of New Products and Services. Morris will oversee the development of Almac's IXRS technology and enhance the company's metrics-based discipline to the software development process.

Clinipace Worldwide (Morrisville, NC) announced company executive Ran Frenkel, RPh, Vice President, International Business Development, will take on additional responsibility as the Managing Director, EMEA.

PharmaNet/i3, (Princeton, NJ) inVentiv Health's clinical segment, announced that Susan C. Stansfield, PhD, has joined the company as Executive Vice President of Clinical Operations for Phase II-IV Development in Europe, Middle East, and Africa (EMEA), Asia-Pacific, and Latin America.

CITrials (Costa Mesa, CA) announced the appointment of Timothy L. Welke to the newly created position of Vice President of Clinical Operations.

Secretary's Advisory Council on Human Research Protections (SACHRP) (Washington, DC) appointed new member Owen Garrick, MD, MBA. SACHRP resides within the Office of Human Research Protections, a division of the Department of Health and Human Services. In this role, Garrick will help provide advice and recommendations to Secretary Kathleen Sebelius on issues and topics pertaining to protection of patients in clinical trials. Garrick is currently President and Chief Operating Officer for Bridge Clinical Research.

PAREXEL (Boston, MA) announced that its Chairman and CEO, Josef von Rickenback, has been named 2013 Chairman of the Association of Clinical Research Organizations (ACRO). Since its founding in 2002, ACRO has been committed to highlighting CRO expertise in all aspects of the clinical research enterprise.

Chiltern International Limited (London, UK and Wilmington, NC) announced the appointment of Roger Hunter as Vice President of Strategic Partnerships in the Business Development function.

ICON plc, (Dublin, Ireland) announced that Robert L. Howie, Jr. has been appointed Chief Marketing Officer. Howie is an experienced executive with a background in marketing, business development, market research, publishing, and communications.

BRANY(Biomedical Research Alliance of New York) (Lake Success, NY) announced the following staff changes: Raffaella Hart, BS, CIP, CIM, has been promoted to Vice President of Institutional Review Board and Institutional Biosafety Committee Services. Michael Brown has joined as an IRB analyst. In this role he will work closely with BRANY's central IRB to ensure regulatory compliance and prompt reviews.

CDISC (Austin, TX) announced the addition of five individuals to the CDISC Board of Directors (BoD) for a three-year term. Carolyn Compton, MD, PhD, Michael Glickman, Douglas Peddicord, PhD, Stephen Pyke, and John Speakman each contribute unique skillsets to the BoD that will assist CDISC as it moves forward with its strategic goals in 2013. Appreciation goes to Steven Hirschfeld, MD, PhD, and Robert Goodwin, who completed their CDISC board service in December 2012 and to Wayne Kubick who has become the Chief Technology Officer for CDISC.


Synteract, (San Diego, CA) portfolio company of San Francisco-based Gryphon Investors, entered into a definitive agreement under which they will acquire Harrison Clinical Research (HCR). HCR, headquartered in Munich, Germany, has operations in Europe, Israel, and South America, in addition to a US office in Princeton, NJ.


BBK Worldwide (Newton, MA) has been awarded a 2012 Bronze Health Award in the Patient Education Portal Website category for their online diabetes community, The Health Information Resource Center has recognized BBK for its digital resource for consumer and health professionals. BBK also announced that the company received re-certification as a Women's Business Enterprise. This certification comes from the Center for Women and Enterprise, a regional certifying partner of the Women's Business Enterprise National Council.

ClinTec International (Glasgow, UK) announced Rabinder Buttar, PhD, has received the Scottish Asian Business "Women of the Year" award. The Scottish Asian Business Awards honor the achievements, determination, and hard work of the Scottish Asian entrepreneurs who have been the leaders and drivers of growth in their industry.

Clinical Research Advantage (CRA) (Tempe, AZ) received a national honor 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 Silver Award for Executive Team of the Year. Mark S. Hanley, Chief Executive Officer, and David Bruggeman, President and Chief Operating Officer, were recognized for their strategic vision and leadership in growing the company.

Advanced Clinical, (Deerfield, IL) provider of clinical research solutions, announced their celebration as 2013 marks the 25th year in business for the Advanced Group.

Company News

Patient-Centered Outcomes Research Institute (PCORI) (Washington, DC) announced the PCORI Challenge, a competition to create a system for connecting healthcare researchers and patient partners to advance patient-centered comparative effectiveness research. PCORI launched the challenge in collaboration with Health 2.0, a San Francisco-based company that promotes and showcases new technologies in healthcare through a series of conferences, code-a-thons, challenge competitions, and more. PCORI will award cash prizes to the winning developers in two categories: conceptual model ($10,000) and prototype ($40,000).

INC Research, LLC, (Raleigh, NC) announced it has reached a milestone with its metrics-driven clinical trial outsourcing methodology known as the Trusted Process, completing its 500th QuickStart Camp. Designed to align expectations and build study ownership across the entire project team from the onset of a study, INC Research's QuickStart Camp is a week-long collaborative meeting featuring a series of moderated gatherings to drive accurate study planning and conduct proactive risk management.

ICRC-Weyer (Berlin, Germany) has made further enhancements to their pharmacovigilance risk management. By integrating medical review procedures into the pharmacovigilance system, the company now aims to provide efficient risk management strategies inline with current market and regulatory developments.

Healthcare Education Services (St. Albans, UK) aims to continue offering comprehensive training in 2013. Courses include oncology, asthma and COPD, biomarkers, cardiovascular medicine, hematological malignancies, and breast cancer.

Celerion (Lincoln, NE) announced the expansion of its capabilities in the respiratory therapeutic area, with the addition of a dedicated Bronchoscopy Suite in the Belfast, Northern Ireland, UK facility. The Bronchoscopy Suite allows bronchoalveolar lavage (BAL) to be performed within the Celerion clinic, utilizing study participants from their database.

ERT, (Philadelphia, PA) a global technology-driven provider of health outcomes research services to biopharmaceutical organizations, medical device companies, and CROs announced milestones that reinforce its position as an eClinical trial solutions provider in Japan. ERT completed registration for Kabushiki Kaisha in Japan and has formed a fully-owned subsidiary, ERT Asia Group, Ltd. Along with this registration, ERT will grow the number of local resources in Japan that will work directly with its customers to deploy Japan-based projects. ERT also announced a series of upcoming industry conferences and company-sponsored events which will feature presentations by members of ERT's Scientific and Regulatory teams. Scientific and Regulatory team members will speak at the following events: Mar. 4-6: DIA EuroMeeting; Amsterdam, Netherlands. Wolfgang Summa, MSc, PhD, will present "Data at the Heart of Clinical Trials—the Key to Successful Health Outcomes Research." Mar. 18-21: BioPharm Asia; Sentosa, Singapore. Robert Brown will present "Improving Clinical Trial Data Collection, Management, and Analysis." Apr. 10-12; PROFICIENCY™ 2013; Fort Lauderdale, FL. ERT scientists will present with industry and regulatory experts on topics pertaining to the scientific, regulatory, and commercial considerations of effectively capturing patient safety and efficacy data.

inVentiv Health, Inc. (Burlington, MA) announced that its existing clinical research organization, PharmaNet/i3, will be renamed inVentiv Health Clinical. This renaming reflects the closer alignment between the clinical segment and inVentiv's commercial and consulting services. inVentiv Health Clinical offerers early stage (Phase I), Phase II-III, late stage (Phase IV), clinical development, and clinical staffing services to healthcare companies worldwide.

New Products

ArisGlobal (Stamford, CT) announced the availability of agDisclosure 3.1, a system that aims to enable sponsors to plan, prepare, and manage submissions to multiple registries. agDisclosure is the newest addition to ArisGlobal's Total Clinical, a platform for clinical research that includes EDC, CTMS, ePRO, medical coding, supply chain management, and safety reporting—all accessed via agWorld, a central clinical portal.

Clinipace Worldwide (Morrisville, NC) announced significant innovations to its proprietary TEMPO eClinical platform. As a private cloud-based application, TEMPO serves as the technology foundation to all of Clinipace's clinical development service delivery teams.

New Facilities

Novella Clinical (Research Triangle Park, NC) announced the relocation of the company's US headquarters to 1700 Perimeter Park Drive, Morrisville, NC, in the heart of Research Triangle Park. The 77,000+ square foot Class A office building is now home to Novella's more than 300 RTP office-based staff. Novella used green construction practices to upfit the building including utilizing low- and no-VOC carpets and paint, installing LED lighting, reusing materials, and recycling construction debris. These measures minimized landfill waste during construction and will improve air quality and energy efficiency moving forward.

Cato Research, (Durham, NC) in its 25th year of global drug development, and Cato Bioventures, CATO's venture arm, announced the opening of a new office in Houston, TX. (San Diego, CA) a full-clinical service, German-based CRO, with a new office in Carlsbad, CA, has entered into an agreement with the Center for Oncologic Diagnosis and Treatment (Oncocard) in Romania to be its preferred provider of clinical trial services. The center, developed with the first private investment funding in oncology in Romania, is new and features state-of-the-art services and equipment.

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