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Contributed by Mark Levine

The Need for an Outsourcing Industry Association

The outsourcing industry, defined as providers to pharmaceutical, biotechnology, and medical-device companies, continues to evolve and adapt to the changing market conditions and demands placed on it by sponsor companies. To meet and exceed the expectations placed on them, outsourcing providers need a forum for information sharing, education/training programs, and standards development and implementation, which translates into the need for a new association. Currently, many industry associations exist. For example, the Drug Information Association (DIA) develops training and education programs for the pharmaceutical healthcare sector; the Biotechnology Industry Organization (BIO) fosters advocacy and networking for biotechnology companies; and the Association for Contract Research Organizations (ACRO) organizes large CROs to advance medical-product development. In addition to these few, others exist in specialized areas of clinical development. But there is no association that provides a single focus on the needs of outsourcing and its related providers. The New Association A new industry association is being created to consist of small- to midsized service providers that offer services that support and help pharmaceutical, biotechnology, and medical-device companies in bringing their products to market. The services of member companies will span all phases of the clinical-development life cycle, from discovery to postmarketing activities. In addition, membership will not be limited to CROs; all disciplines such as central laboratories, technology vendors, patient-recruitment companies, medical communications agencies, contract salesforce organizations, and more will be included. The only defining member criteria is that companies have the following: less than 500 employees and less than $100 million in revenue. This organization will be the voice of the smaller outsourcing providers, as they will shape the industry. What the New Association Hopes to Achieve The new association is very ambitious; it will serve as a forum for information sharing, educational and professional development, networking, the creation of new standards and efficiencies, and lastly, providing member companies with an outlet to be heard. To be successful, service providers must work in collaboration with sponsor companies to assure that their expectations of us are clearly defined and are exceeded. A complaint that we hear often from sponsors is that their expectations of service providers are typically met, but rarely if ever, exceeded. Collectively, as an industry, we need to work on this. Overall, the association will serve as a vehicle to share information, experiences, and new ideas. Future processes, standards, and systems will be developed, which will support both service providers and sponsor companies, regardless of discipline. This will enable companies, sponsors, and providers to remain competitive and profitable. How to Get Involved The new association will commence at the Partnerships with CROs (and Other Outsourcing Providers) Conference being held in Orlando, Fla., from April 26-28, 2004. All interested companies are invited to attend to discuss the goals of the association. In addition, interested members will have the opportunity to vote on the association’s name and board members. Mark Levine is the director of business development at Averion Inc., Framingham, Mass. Mr. Levine has spent the past 11 years working for outsourcing providers to the pharmaceutical, biotechnology, and medical-device industries. For more information, contact Mr. Levine at mlevine@averioninc.com. PharmaVoice welcomes comments on this article. E-mail us at feedback@pharmavoice.com.

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