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Synteract Offers Free Educational Seminar for Pharmaceutical and Biotech Companies in Southern California

Expertise on CDISC Standards and Legal Representation in the EU Tapped

SAN DIEGO – Mar. 18, 2009 – Synteract, Inc., a full-service contract research organization (CRO) dedicated to meeting the clinical research, technology, and safety needs of biotechnology, medical device, and pharmaceutical companies, will present a free educational seminar for companies working in these industries on April 7, 2009, from 7:30 – 10:30 am at the Marriott Del Mar in San Diego. Topics covered will include: “CDISC Standards, the CRO and Client Perspective” and “Legal Representation in the European Union.” 

The workshop is appropriate for executives, regulatory representatives, biostatisticians, clinical operations directors, and other strategic decision-makers in the pharmaceutical and biotech industries. Although not directly related, these two subjects are both important topics in the industry and are key aspects for companies doing clinical development internationally. Synteract, as a primary development CRO for solutions that speed the completion of clinical trials, has become an expert in deliverables associated with submissions that follow CDISC (Clinical Data Interchange Standards Consortium) guidelines and offers expertise in the EU’s legal representation mandates through its alliance partner, FGK. 

Micaela Salgado-Gomez, senior manager, clinical programming biostatistics for Synteract, and Spencer Hudson, vice president of biometrics, InterMune, Inc. will be featured speakers for the CDISC session. In addition to a general overview of CDISC and what it means to the industry, the forum will include discussions of CDER (Center for Drug Evaluation and Research) requirements, the benefits of conforming early to submission standards, CDISC potential, and the “do’s and don’ts” of vendor selection. 

According to Synteract executives, understanding submission requirements and challenges enables sound planning which results in reduced analysis and submission development time. 

“Our experience has shown us that up-front planning and implementation of standards early in phase 2 and 3 trials produce the most cost-efficient and time-effective strategies for potential submissions” says Salgado-Gomez. “Consistent attention and adherence to submission standards throughout the drug development process enhance the submission package thus providing a thorough and understandable deliverable that is acceptable to the FDA and that can be more easily and quickly reviewed.” 

Dr. Edgar Fenzl, managing director of FGK Clinical Research GmbH, is the highlighted speaker for the session on Legal Representation in the EU. Dr. Fenzl’s presentation will include an overview and requirements of legal representation in the EU, as well as the outcome of the first inspection of his organization, which provides this service. FGK and Synteract have been working together for several years and have successfully managed several international studies together in multiple indications, including coronary artery by-pass grafting, cystic fibrosis, and several oncology indications. 

“As the number of studies with a European component is increasing steadily for US based pharmaceutical, medical device, and biotech companies, proper legal representation in the EU has become increasingly important,” said Dr. Fenzl. “We have shown that US based companies can be compliant with EU regulatory demands at a reasonable cost and effort, and we’ll share our experience.” 

Interested participants can register for the seminar by going to, or by contacting Jennifer Jackson at 760-476-8806 or 

About Synteract 
Established in 1995 by two veterans of the pharmaceutical industry, Synteract is a privately held, full-service contract research organization, dedicated to meeting the clinical needs of biotechnology, medical device, and pharmaceutical companies. The company’s mission is to provide high quality yet personal service, working closely with drug and device sponsors as though a department within their company. Headquartered in Carlsbad, California, with a second office in Research Triangle Park, North Carolina, Synteract has clinical trial expertise in a wide range of therapeutic areas, including a strong emphasis in oncology, central nervous system (CNS), cardiovascular disease, and ophthalmology. For information, or (760) 268.8200. 

Beth Walsh 


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