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Bert Spilker

Contact Us:

8004 Overhill Road
Bethesda, Maryland
20814-1145

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com


Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . ADVISORY BOARDS (CURRENT)

    Brief descriptions of organizations where Bert Spilker is a member of a scientific advisory board.

    ACURIAN

    Acurian is the leading provider of clinical trial patient and investigator recruitment solutions for the biopharmaceutical industry. Acurian's proprietary databases allow biopharmaceutical companies to identify qualified physicians and patients for clinical studies, allowing new drug therapies to reach patients more rapidly. To date, Acurian has worked with 40 biopharmaceutical companies, including the seven largest in the world, as well as with mid-sized and small pharmaceutical and biotech companies. Acurian has already helped accelerate the launch of more than 60 clinical trials. With a seasoned management team, innovative technology solutions, a Safe Harbor certification to serve biopharmaceutical clients in Europe and more than $33 million in total funding from top technology and healthcare investors, Acurian is poised for long-term success. Additional information about Acurian is available at www.acurian.com.

    ERNST & YOUNG'S COMPLIANCE LEVERAGING

    Compliance leveraging is a new methodology for certifying compliance through an independent assessment of regulatory adherence. This technique can be used for all regulated industries. In the pharmaceutical industry, it is most effectively applied to mergers and acquisitions, licensing activities and other areas. It benchmarks medical research and products to federal requirements, and to the best practice and performance standards. This identifies superior regulatory compliance and enables investors to distinguish and reward companies with high standards, and thus promotes activities that lead to the enhancement of public health.

    In other regulated industries, this approach will certify adherence to high standards and provide guidance to those companies who do not achieve high standards. Details are available from Leslie A. Platt (e-mail: leslie.platt@ey.com)

    LEARNWRIGHT

    LearnWright is an e-learning company that develops and markets engaging, interactive, high-value multi-media training programs on a business-to-business basis to the pharmaceutical/healthcare industry. The company's products uniquely combine training, testing, and individual performance tracking with a web-based delivery strategy, enabling users to acquire skills and demonstrate compliance on the job and off - anytime - anywhere.

    The current focus of LEARNWRIGHT's course offerings is regulatory compliance training for pharmaceutical manufacturing, mandated by the Food and Drug Administration (FDA) and known as "Good Manufacturing Practices" or GMP. Increasingly, the FDA is putting pharmaceutical manufacturers on notice that worker awareness of GMP is insufficient by itself and must be supplemented with actual understanding through effective training. With limited resources, training departments are being asked to provide more regulatory and technical training to manufacturing, as well as technical, laboratory, and management personnel. LEARNWRIGHT's courseware can meet this demand, with the integrated testing and user performance tracking, allowing manufacturers to demonstrate worker mastery of these regulations. Manufacturers have validated this need and our approach by offering to fund this course development. www.learnwright.com

    MEDIADATA

    Medidata is an information technology company focused on improving and expediting the clinical trials process. Medidata applies advanced medical informatics to the labor-intensive, paper-based methods used in today's clinical trials.

    TRIALSPACE, the company's Internet-based product suite, connects all trials constituents through a standard operating platform that enables a complete systems approach to clinical trials. At the core of TrialSpace is an industry-exclusive technology called iCP (Intelligent Clinical Protocol). Researchers use the TrialSpace planning tools to design and optimize trials through real-time simulation and modeling feedback. The result is an optimized model of a trial-an iCP. This optimized trial model also generates and manages all data required for efficient trial execution.

    DATAEDGE, recently acquired by Medidata, is a suite of applications that contain the world's largest library of clinical trials grants and protocols DataEdge data and tools help sponsor organization to launch clinical trials more effectively.

    More information is available at www.mdsol.com/.

    UNC-CERT

    UNC (Chapel Hill, NC) CERT (Center for Education and Research in Therapeutics) is one of several academic centers that conducts research on the effective and safe use of therapeutics. This program was established in 1997 by the FDA Modernization Act and is administered by AHRQ (Agency for Healthcare Research and Quality) in consultation with FDA. The mission is to develop, translate and disseminate objective clinical information on therapeutics; and, to increase the awareness of effective and safe use of therapeutics. This mission is to be achieved through research, education and cooperation. Each of the Centers has a different focus and that of UNC-Chapel Hill is promoting national therapeutics in children. The CERTS emphasizes education to increase the awareness of the appropriate use of medical products, and they work in partnership with both the public and private sector.


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