Award Winning People, Award Winning Software

Octagon is known for our domain expertise and our employees and solutions have been acknowledged in the following areas:

• ViewPoint^® Customer received BIO IT World Best Practices Award in Regulatory
  in 2004
• Nancy Smerkanich
  • Received the 2004 DIA Outstanding Service Award
  • Recognized in the 2005 PharmaVOICE 100 for “Industry’s Influential Thought Leaders”
  • Finalist for the 2007 Women in Business Awards for “Best Entrepreneur”
  • Finalist for the 2008 Women in Business Awards for “Best Executive”
• Jim Walker
  • Ernst & Young (2002) - nominated for Life Sciences Achievement & CEO under 40, Finalist for Start up Company of the Year
  • Ernst & Young (2003) - Ernst & Young Entrepreneur of the Year Award in Emerging Company Category
  • 2003 High Tech Pioneer Award (Hale and Dorr & KPMG)
  • 2003 Deloitte and Touche Fast 50 Rising Star
  • Finalist for CEO Under 40
  • Finalist in American Business Award for Best Company
  • Nominated for Enterprise Awards categories: CEO under 40, Life Sciences Achievement Award, Life Sciences Technology (nominated by customer)
  • Accepted and attended CEO Academy run by Mayer Leadership Group
  • 2004 Deloitte and Touche Technology Fast 500 and Fast 50
  • 2003-2007 Philadelphia 100 (List of fastest growing, privately held companies in the Philadelphia region)
  • 2004 nominated one of Philadelphia Business Journal's 40 under 40
  • 2004 Entrepreneur Magazine Hot 100
  • 2006 American Business Award, Winner - Most Innovative Company
  • 2006 American Business Award, Finalist - Best Executive
  • 2007 Deloitte and Touche Technology Fast 50 and Fast 500
  • 2007 Philadelphia 100 Hall of Fame
  • 2007 Inc. 5,000
  • Finalist in the 2008 American Business Awards for Best Chairman
  • 2008 Inc. 5000 List
  • 2008 Deloitte Technology Fast 50 and 5000 List

In addition, we are proud of the following achievements:

• 100% repeat business
• Active membership and participation in the CDISC, HL7 (SPL) and DIA
  SIAC initiatives
• Corporate Sponsor of CDISC, CDISC Registered Solutions Provider, Primary Trainer for CDISC SDTM for Human Clinical Trials
  • Co-lead for CDISC SDTM team
  • 2 Primary authors of SDTM Standard
  • CDISC SDS Chairman
• Completed the conversion of electronic clinical study data to CDISC SDTM format for over 250 studies and 3,500 domains
• 80 Clinical Team Members, including 4 members either CDISC or CDASH
• 18 Regulatory Affairs professionals, 14 US and 4 EU
• One of the largest pool of trained Electronic Submission Publishing professionals with over 80 resources
• Completed over 300 original applications
• Produced over 250 electronic submissions
  • 100 eCTD applications
• Over 60 eCTD Submission Stewardship clients with over 1200 sequences
• eCTD Experience:
  • 28 NDAs, 48 INDs, 4 ANDAs 4 BLAs, 3 NDSs, and 6 MAAs (28 Countries Decentralized)
  • Over 100 active eCTD projects
  • Over 40 Ongoing Original Applications
  • Mock Submission: 57 Instances (38 IND and 19 NDA)
  • Only vendor to participate in the FDA eCTD Pilot
  • VP, Regulatory Co-chairs, DIA eCTD subteam
  • Solid relationship with FDA and recognized as an authority on eSub topics
• Never missed a filing date; have beaten many dates
• No RTFs
• Our Process Consulting milestones include:
  • Over 100 clients using StartingPoint^®
  • Over 30 clients using eCTD JumpStart™
  • Over 20 eSub Assessments with most resulting with roadmap implementation consulting