Octagon Research Solutions
Company: Octagon Research Solutions, Inc., Wayne, PA
Company Description: Octagon Research Solutions is the leader in the electronic transformation of clinical R&D. We offer a suite of regulatory, clinical, process and IT solutions to the life sciences industry. Our integrated suite of offerings is built upon deep domain knowledge, cross-functional eSub expertise, a holistic process approach and integrated solutions.
Nomination Category: Company, Office & Product Awards Categories
Nomination Sub Category: Most Innovative Company
Nomination Title: Octagon Research Solutions
1. Tell the story about what this nominated company achieved in the past year (up to 500 words). Focus on specific accomplishments, and relate these accomplishments to past performance or industry norms. Be sure to mention obstacles overcome, innovations or discoveries made, and outcomes:
Since its inception in 1999, Octagon Research Solutions, Ins., a leading process-centric solutions provider that offers a suite of regulatory, clinical, processes and information technology (IT) solutions to the life sciences industry, has grown by more than 4500% with 2005 being no exception. Last year, Octagon grew its revenue by 42% and its staff by 115%, expanded its corporate headquarters in Wayne, Pennsylvania and answered the call from the industry for a global presence by launching international operations with an office in Amersham U.K.
Octagon has been able to grow so significantly due to its strong commitment to providing innovative technology solutions and expert consultative services to pharmaceutical and biotechnology companies. In 2005, Octagon continued to lead the electronic transformation of clinical R&D through its many activities including:
*Developing new and enhancing existing technology solutions that assist companies in improving their clinical R&D processes including its process management solution, ViewPoint™, and its regulatory submission document authoring templates tool, StartingPoint™.*Launching new consultative services that assist companies in compliance with industry standards including its oSubmission Stewardship Program™, which supports the production and maintenance of regulatory submissions oStructured Product Labeling (SPL) Stewardship Program which includes training, implementation consulting and conversion services. oClinical Data Strategies offering which include consulting and training on emerging CDISC data standards as well as conversion services.*Forming partnerships with other provider organizations to help improve its own solutions and services through integration including DataLabs Inc.’s DataLabsXC technology that supports electronic and paper-based clinical trial processes and offers full integration of clinical data process with enterprise-wide submission processes.*Distributing an educational quarterly newsletter that addresses industry issues and provides updates on various industry trends, initiatives and standards.*Hosting various educational seminars and webinars to help companies address emerging regulations and standards involving clinical R&D submissions.
As a result of Octagon’s commitment to improving clinical R&D processes and loyalty to helping the life sciences industry advance, many industry-related organizations recognized the company in 2005 including:
*The Food & Drug Administration recognized Octagon’s subject matter experts for their contribution to various initiatives including: oCommissioner’s Special Citation Award given to Octagon’s Director of Product Strategy for contribution to the Health Level Seven Structured Product Labeling Working Group, which developed the “SPL Implementation Guide for FDA Content of Labeling Submission” oLeveraging/Collaboration Award given to Octagon’s vice president of clinical data recognizing the Clinical Data Interchange Standards Consortium (CDISC) Submission Data Standards (SDS) Team for their work in the creation of the Study Data Tabulation Model (SDTM) and accompanying implementation guide.*The Clinical Data Interchange Standards Consortium (CDISC) designated Octagon as primary trainer for its Study Data Tabulation Model (SDTM) for human clinical trials and designating Octagon as a Registered Solutions Provider and Corporate Sponsor.*PharmaVoice magazine recognized Octagon’s vice president of regulatory affairs as one of the industry’s most inspiring people on its annual “PharmaVoice 100” list.*Inc. magazine recognized Octagon as one of the fastest-growing companies in the country on its “Inc. 500” list and the Philadelphia Business Journal recognized Octagon as one of the fastest-growing, privately held firms in Philadelphia on its “Philadelphia 100®” list.*Edison Venture Fund awarded Octagon $3 million in venture capital funding to help the company continue to develop and deliver innovative technology solutions to the life sciences industry.
2. List hyperlinks to any online news stories, press releases, or other documents that support the claims made in the section above. IMPORTANT: Begin each link with http://, and enclose each link in square brackets; for example, [http://www.youraddress.com]:
*Press release: “Octagon Announces Submission Stewardship Program”
http://www.octagonresearch.com/press_February_14_2005.html
*Press release: “Octagon Research Solutions Attracts $3 Million in Second Round Funding”
http://www.octagonresearch.com/press_April_1_2005.html
*Press release: “Octagon Research Solutions Identified as Primary Trainer for Clinical Data Interchange Standards Consortium (CDISC)”
http://www.octagonresearch.com/press_April_4_2005.html
*Press release: “Octagon Research Solutions Implements SAS Technology to Revolutionize CDISC SDTM Legacy Conversion Offerings”
http://www.octagonresearch.com/press_April_11_2005.html
*Press release: “Michelle McGuiness Receives FDAs Commissioners Special Citation”
http://www.octagonresearch.com/press_May_10_2005.html
Press release: “Tom Guinter Selected to Receive FDA’s Leveraging/Collboation Award”
http://www.octagonresearch.com/press_May_25_2005.html
*Press release: “Octagon Announces First Holistic Approach to eCDT Submission Management Capabilities”
http://www.octagonresearch.com/press_June_23_2005.html
*Press release: “Octagon Announces Structured Product Labeling (SPL) Stewardship Offering”
http://www.octagonresearch.com/press_June_27_2005.html
*Press release: “Octagon Research Solutions Announces New Release of StartingPoint(tm)”
http://www.octagonresearch.com/press/press_december_5_2005.html
*PharmaVoice, January 2005, “E-Submissions: On the Brink of Going Paperless”
http://www.pharmavoice.com/search/details.asp?art_id=158
*Entrepreneur magazine, June 2005, “Third Degree”
http://www.entrepreneur.com/Magazines/Copy_of_MA_SegArticle/0,445
3,321356,00.html
*Philadelphia Business Journal, July 5, 2005, “Octagon establishes European HQ”
http://www.bizjournals.com/philadelphia/stories/2005/07/04/daily5.html
*PharmaVoice, August 2005, “The PharmaVoice 100”
http://www.pharmavoice.com/search/details.asp?art_id=473
*Contract Pharma, September 2005, “Catalyst for Change: CDISC and the Study Data Tabulation Model”
http://www.contractpharma.com/articles/2005/09/catalyst-for-change.php
*American Pharmaceutical Outsourcing, October 2005, “Octagon Selected by Procter & Gamble Pharmaceuticals As CDISC SDTM Conversion Partner”
http://www.americanpharmaceuticaloutsourcing.com/industryNewsArticle.
aspx?article=258
*American Venture Magazine, Q4 2005, “Turning Frustration Into Opportunity: A Life Science Case Study”
http://www.americanventuremagazine.com/articles/210
*Inc. magazine, “Inc. 500”
http://www.inc.com/resources/inc500/2005/profiles/174.html
*FrontLine, Summer 2005
http://www.octagonresearch.com/Newsletters/Summer_2005.pdf
*FrontLine, Fall 2005
http://www.octagonresearch.com/Newsletters/ONewsletter9dV3.pdf
3. Provide a brief (up to 100 words) biography about the leader of this nominated company:
James C. Walker, CEO, Chairman and founder of Octagon Research Solutions, Inc.has been working in the pharmaceutical industry for 15 years. Prior to founding Octagon, he worked as the Senior Manager of Worldwide Regulatory Affairs for the Schering-Plough Corporation. Mr. Walker has extensive experience in all phases of clinical research both FDA and European regulations. He is skilled at process improvement and providing insight across multiple disciplines within drug development. Mr. Walker holds a B.S. in Biological Sciences from Villanova University, a Masters in Environmental Sciences from Rutgers University, and an M.B.A. from Duke University.