Octagon Clinical Data Strategists to co-author on Good Clinical Data Management Practices guide for SCDM


Company News Release

Octagon's Clinical Data Strategists Provide Insight on Good Clinical Data Management Practices


Strategists to Co-Author Chapter in 'GCDMP Guide'

CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leading provider of breakthrough software and services to the life sciences industry, announced that two of Octagon's clinical data strategists will co-author a chapter for the Society of Clinical Data Management's (SCDM) newest release of its "Good Clinical Data Management Practices (GCDMP)" guide, a reference guide/ training manual used by clinical data management professionals. Dan Crawford, director, Clinical Data Strategies and Dawn Kaminski, EDC product manager have collaborated on a chapter entitled, "Laboratory Data," discussing the basic "Do's and Don'ts" of working with all types of laboratory data in Clinical Trials. This contribution will be included in the GCDMP guide. "When new standards are emerging, implementing good practices into your Clinical Data Lifecycle is essential to the quality of your electronic submission," noted Mr. Crawford, "I encourage anyone who is currently in the Data Management profession to use this guide as a tool for ensuring that your clinical trial data is compliant with such standards." Mr. Crawford and Ms. Kaminski bring significant industry experience to their contributions. Mr. Crawford has over 19 years in the pharmaceutical industry, with extensive expertise in the areas of data management, data Integration and standardization. During his tenure at Octagon, Mr. Crawford has been instrumental in the development of products that assist organizations with the adoption and integration of data standards. He also played a key role in the development of ViewPoint® FUSE, Octagon's EDC software platform. Mr. Crawford and Ms. Kaminski's broad experience in data integration and standardization includes: Case Report Form (CRF) design, database development/validation, creation of Data Management Plans, CRF completion guidelines, CRF validation guidelines, data processing, edit check development, Serious Adverse Event (SAE) reconciliation, data listings generation and database audit and lock procedures. In addition, both have worked extensively with clinical programming and statistical analysis. Ms. Kaminski has over 12 years of experience in the pharmaceutical industry. She has worked within every level of clinical data management, from project manager to director. During her tenure at Octagon, Ms. Kaminski has lent her expertise to the development of products such as Data JumpStart, a combination of expert consulting with standardized libraries and templates to assist organizations in the adoption of CDISC SDTM standards. She has also played a critical role in the development of Octagon's EDC Software platform ViewPoint® FUSE. "The SCDM's GCDMP guide is a valuable resource for anyone responsible for managing clinical data," commented Jim Walker, "It is a great honor that two of Octagon's Clinical Data Management experts have been selected to contribute to this respected publication." For more information about Octagon, please visit our website at www.octagonresearch.com or contact us at 610.535.6500 or info@octagonresearch.com. About Octagon Research Solutions, Inc. Octagon is a pioneer and leading provider of breakthrough software and services to the life sciences industry. Octagon's eCTD and CDISC solutions provide the people, process and technology required to optimize drug development from data collection to submission. Our regulatory, clinical, process and software offerings provide a unique combination of deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Berkhamsted, UK. Octagon's EDC Operations are located in Mountain View, CA. For more information please visit www.octagonresearch.com

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