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For release on March 18, 2002
King of Prussia, PA - Octagon Research Solutions, Inc. today announced the expansion of their service offerings to include Vendor Tool Evaluations. This new addition to Octagon’s current services provides a complete approach to electronic clinical research and development initiatives for organizations of any size.
In the biopharmaceutical industry, most competitive organizations have plans to implement processes and tools that support electronic submissions to various regulatory authorities. But internal requirements may vary significantly based on the organizational size, technical infrastructure and product pipeline.
Industry organizations such as the International Conference on Harmonization (ICH) have recently made substantial progress in terms of identifying standards for global electronic submissions, most notably through the eCTD or Electronic Common Technical Document initiative. As the eCTD standards are finalized, industry must prepare for the transition, which may require tool and process changes. In addition, as electronic submission initiatives continue to change, so do the tools that are currently available to industry.
This continuously changing scenario places additional responsibility on regulatory operations and IT professionals to conduct thorough research into electronic submission capabilities while still remaining up to date on industry standards that may impact requirements. Octagon’s Vendor Tool Evaluation is designed to facilitate the evaluation process through the application of regulatory and IT knowledge combined with substantial industry experience.
Jim Walker, President and CEO of Octagon, stated, “So many of our customers are looking for the “right tool”. We have significant experience with all of the industry standard tools and can provide expert guidance in evaluating functionality against specific requirements. Our combined technical and regulatory expertise provides a perfect foundation to support the analysis of electronic submission capabilities. It also complements our existing outsourcing offerings. We can provide production services for a submission while assisting an organization with their tool evaluation processes. As electronic submission initiatives such as the eCTD continue to progress, these activities become increasingly important.”
About Octagon Research Solutions, Inc.
Octagon Research Solutions, Inc. (Octagon) was established in 1999 as a Development Partnering Organization (DPO). Octagon’s founding philosophy integrates regulatory principles and information technology across the clinical research and development process.
Octagon offers unparalleled practical knowledge and industry expertise that spans the research and development lifecycle as well as the supporting business processes and technologies. Our diverse staff, with decades of experience, has been assembled based on the common goal of speeding the entire clinical drug development process. Our offerings are designed to complement and enhance organizational capabilities in order to expedite time to market.
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