Business and People Update July 2009

July 1, 2009
Marissa Shapiro

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2009, Volume 0, Issue 0

Industry news focusing on the people and organizations who work in the clinical trials profession.

People

David Del Bourgo

•With more than 20 years of expertise in medical device technology and health care business management between David Del Bourgo, the new business development director, and Sylvain Yon, the new vice president of research and development, Theraclion (Paris, France), will utilize the strengths of these two additions to prepare for an upcoming commercialization of a new device.

Sylvain Yon

Rick Turner

•In his new position as a member of Cardiocore's (Washington, DC) scientific consulting team, Rick Turner, PhD, will assist sponsors with strategic planning, protocol development, expert reporting, and regulatory submissions.

•A promotion to group president has Randy Kehrmeyer responsible for Kforce Clinical Research's (Tampa, FL) business development functions and enhancing relationship management and service levels for customer partnerships.

Randy Kehrmeyer

•As the former director of the Technology Investment Banking Group at Robert W. Baird and a 17-year veteran in enterprise software and IT markets, Michael Bruns has now joined ClearTrial (Chicago, IL) as chief operating officer.

•Replacing Takatoshi Sato as the Chair of DIA's (Horsham, PA) Regional Advisory Council of Japan (ACJ) is Tatsuo Kurokawa, PhD, a former employee of the Ministry of Health and Welfare Japan, the World Health Organization, and what is currently the Pharmaceuticals and Medical Devices Agency.

•Bringing with him 25 years of experience in the pharmaceutical commercial sector, Richard Pilnik will now serve as the president of Innovex (Research Triangle Park, NC), a Quintiles company.

•Expanding its executive team, ProTrials (Mountain View, CA) has added John Foster to the position of the director of business development, which is a newly created role for the company.

•Joining the Virtify (Cambridge, MA) team as the new executive vice president of commercial operations is Stephen Bergson, who will lead the company's worldwide sales and marketing efforts.

•To support Clinipace's (Morrisville, NC) team of clinical development professionals, the company has added three new advisors: William McCulloch, MB, Joseph DeVeaugh-Geiss, MD, and Michael Hamrell, PhD, an editorial advisory board member of Applied Clinical Trials.

Lee Potts will now serve as project director of Regulatory Presentation Management (Research Triangle Park, NC), where he will utilize his 16 years of experience in tactical and logistical guidance.

Alliances

  • Allowing M2S (West Lebanon, NH) to now offer its clients more options for efficient, cost-effective image collection and transfer is a partnership with AG Mednet (Boston, MA), a HIPAA and 21 CFR Part 11 compliant diagnostic imaging network.

  • Chiesi Farmaceutici SPA (Parma, Italy) has chosen to use Sparta System's (Holmdel, NJ) TrackWise software for the management of audits, non-conformance, corrective and preventative actions, and workflow verification.

  • An integration between QUMAS (Jersey City, NJ) Doc Compliance and Datafarm (Marlborough, MA) S-Cubed will provide customers with an all encompassing solution for creating and managing eCTD, non-eCTD, and paper submissions to global regulatory agencies.

  • Transitioning from a paper-based to an EDC system, U-Systems (San Jose, CA) chose to use Medidata Solution's (New York, NY) Medidata Rave for its SOMO-INSIGHT clinical study of an automated breast imaging ultrasound system for early detection of breast cancer.

  • Gemin X Pharmaceuticals (Montreal, Canada) has chosen Clinical Force's (Raleigh, NC) CTMS solution for the management of its clinical trials and has thus far installed the project management, regulatory/ethics management, CRF tracking, visit reports, and site payment modules.

  • After the signing of an alliance between SIRO (Mumbai, India) and Advanced Clinical Trial Solutions (Flemington, NJ), SIRO will now be able to expand its oncology clinical development and patient recruitment services into North America, while Advanced Clinical Trials Solutions will gain access to SIRO's services in India and European countries.

  • Phoenix Eagle Company (Mount Lawley, Australia) and Datapharm Australia (Drummoyne, Australia) have signed an agreement to conduct the first randomized clinical trial of a papaya product intended to heal venous and pressure ulcers.

  • Extending on a contract that was signed in 2007, Phase Forward (Waltham, MA) and Everest (Little Falls, NJ) have resigned a multiyear, multi-million dollar agreement that entails Everest implementing Phase Forward's InForm and Central Designer in-house.

  • With the intent of bringing more clinical studies to India, Novotech (Sydney, Australia) and ETI Klinical (Bangalore, India) have entered into a joint venture that requires the companies to collaborate and share both experience and services to serve regional and international pharma companies.

  • Being selected to provide Johns Hopkins University with data management software and services for a Phase I clinical trial of a new vaccine is C-tasc (Baltimore, MD), which will provide its StudyCTMSTM for under $50,000.

  • The Academy of Molecular Imaging has chosen American College of Radiology (ACR) Image Metrix (Philadelphia, PA) to provide data and image storage infrastructure for a randomized PET/CT bone imaging clinical trial.

Awards

  • This past April, 514 Academy of Clinical Research Professional (Denver, CO) members were honored for maintaining their Certified Clinical Research Associate (CCRA) or Certified Clinical Research Coordinator (CCRC) status through the Academy for 10 years.

  • At the 2009 World Vaccine Congress, Accelovance (Rockville, MD) received the Vaccine Industry Excellence (ViE) award as the "Best Contract Research Organization," which is intended to highlight the importance of contract research services within the vaccine industry.

  • Four awards were given to SCORR Marketing (Kearney, NE) at the 26th Annual Healthcare Advertising Awards competition, including a bronze award for the ACR Image Metrix Web site, a merit award for Xcelience, and also merit awards for a BASi campaign print ad and trade show booth.

  • Based on an independent survey of pharmaceutical and biotechnology companies that questioned their experience with CROs and general trends affecting the CRO industry, ICON has been named as a favorite Contract Research Organization to work with by the fourth annual "CRO Industry Update," conducted by William Blair & Company in association with CenterWatch.

  • The 2008 Pfizer Development Operations' "Strategic Supplier Excellence Award," has been given to Kforce (Tampa, FL) in recognition of its consistent performance in quality, service delivery and reliability, innovation and business processes, and customer service.

  • The Spanish entity of i3 (Basking Ridge, NJ) has been ranked as one of the top 10 places to work in Spain among companies of 100 to 250 employees by the Great Place to Work Institute (San Francisco, CA), which was primarily determined by employee responses to an issued survey.

Company News

  • Adding to its already accredited laboratories in New York and Ireland, ICON's (Dublin, Ireland) Singapore and India facilities have recently received accreditation from the College of American Pathologists (CAP) as well.

  • Beyond a name change to CRF Health, the former CRF Inc. (Lansdale, PA) has also made changes to the look of its Web site and established new marketing material.

  • The SNM Clinical Trials Network (Reston, VA) announced that it has successfully scanned and imaged a prototype clinical PET oncology imaging simulator (phantom) at four imaging centers.

  • Responding to an increase in demand for flexible, skilled monitoring resources, Phlexglobal (Buckinghamshire, UK) has expanded its monitoring services division.

  • The marketing agency SCORR Marketing (Kearney, NE) has been chosen to provide Frontage Laboratories (Exton, PA) with a marketing plan, brand development, Web site, and trade show components.

  • With the design of a new Web site, Syntagon (Södertälje, Sweden) intends to offer visitors in-depth information on the company's services, current industry news, and a wider variety of case studies.

  • Becoming PPD's (Wilmington, NC) third central lab to earn accreditation by the College of American Pathologists is the company's Beijing facility.

  • Continuing on its initiative to expand unit capacity, SGS (Lombard, IL) has expanded its Phase I units with the addition of 22 new hospitalization beds in the company's Stuivenberg, Belgium, hospital, bringing SGS' overall bed capacity to 184.

  • An upgrade to ICR's (Bourne End, UK) eLearning education program will feature 10 eLearning modules, all of which now include Flash technology that offers interactive education courses for clinical research professionals.

  • Cardiocore (Washington, DC) has announced advancements to its Holter Bin Methodology for ECG data analysis through its success in reducing potential for false positive outcomes in Thorough QT studies by isolating heart rate-related QT effects.

  • Clinipace (Research Triangle Park, NC) has been awarded four new projects by Small Bone Innovations (Morrisville, PA) that will require the company to provide mostly electronic data capture and data management services.

  • The new advocacy group, The Patient Recruitment Organization (PRO) Steering Committee (Philadelphia, PA), is comprised of a select delegation of patient recruitment leaders and has set itself the goal of identifying and addressing ongoing issues to help strengthen this particular industry.

  • Certifying clinical data managers since 2005, the Society for Clinical Data Management (Milwaukee, WI) has announced the certification of its 400th Certified Clinical Data manager.

  • In response to an increasing need from industry and government to understand how drugs and medical devices are working in patients in real-life settings, HealthCore (Wilmington, DE) is developing the Integrated Research Network, which is a collaborative community of practicing physicians who participate in real-world prospective effectiveness research.

  • Intended to make the study feasibility/site selection process more efficient, ACORN (Memphis, TN) has developed the technology STAR—Site Tracking And Recruitment.

Mark Richardson, Managing Director of Phoenix Eagle Company Pty Ltd, shakes the hand of Helen Allars, Chairman of Datapharm Australia Pty Ltd, after she signed an agreement with the company at the BIO meeting in Atlanta, Georgia, in late May.

Mergers/ Acquisitions

  • Enabling Phase Forward (Waltham, MA) to extend its portfolio of clinical data solutions is its $14 million acquisition of Waban Software (Cambridge, MA), a privately held company.

  • Upon a rebrand under the name BioClinica (Newtown, PA), the companies Bio-Imaging Technologies and Phoenix Data Systems will finally complete the concluding stages of a year-long merger that began when Bio-Imaging acquired Phoenix Data.

  • While still subject to customary approvals and closing conditions, a recent agreement will lead to the acquisition of MDS Pharma Service's (King of Prussia, PA) Phase II-IV operations by INC Research (Raleigh, NC).

  • In acquiring the assets of the former Qualia Clinical Services, ICON (Dublin, Ireland) obtained a 33,000 square-foot Phase I facility with a capacity of up to 100 beds in Omaha, Nebraska.

  • By acquiring Xcelodose 600S system, AAIPharma (Wilmington, NC) hopes to enhance its capabilities to rapidly supply preclinical and early phase clinical GMP supplies.

ERT's new facility located in Philadelphia, PA.

New Facilities

  • In response to a growing client demand in East Asia, PPD (Wilmington, NC) has expanded its Phase II-IV clinical development services with the opening of an office in Tokyo, Japan.

  • To accommodate recent growth, ERT (Philadelphia, PA) has transitioned into a new facility located in Philadelphia that is over double the size of the company's previous building.

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