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 DIA Outstanding Service Award for 2004, Finalist in the "Best Entrepreneur", " 'Service Businesses' " category in The 3rd Annual Stevie Awards for Women in Business 2007
- 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
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
- The largest pool of trained Electronic Submission Publishing professionals with over 70 resources
- Completed over 250 original applications
- Produced over 850 electronic submissions
- Over 40 eCTD Submission Stewardship clients with over 365 sequences
- eCTD Experience:
- 15 NDAs, 30 INDs, 4 ANDAs 1 NDS and 3 MAAs (5 Countries Decentralized)
- Over 75 active eCTD projects
- Over 25 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 Solutions milestones include:
- Over 100 clients using StartingPoint®
- Over 30 clients using eCTD JumpStart™
- Over 20 eSub Assessments with most resulting with roadmap implementation consulting
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