Contact Us Global Achievements

Clinical Programming

Octagon is different from traditional clinical service providers because we leverage the power of electronic submissions throughout the clinical process. We employ extensive domain knowledge in every engagement to help enhance deliverables and minimize rework. Our membership and active participation in CDISC initiatives position us on the leading edge of eSubmission data requirements and other changes to the Clinical R&D landscape. In addition to our strategic data transformation offerings, we continue to provide the following services:

Data Management

  • CRF Design & Development
  • Clinical Database Design & Implementation
  • Database Cleanup (DCFs)
  • Medical Dictionary Coding (MedDRA, WHODRUG, WHOART, COSTART)
  • SAE Reconciliation

Medical Affairs

  • Clinical Study Report Writing
  • Investigator Brochure Compilation and Updating
  • Pharmacovigilance
    • Classification, Analysis and Determination of AEs and SAEs
  • Physician Data Safety Monitoring
  • Clinical Safety & Scientific Review


As industry strategies for outsourcing continue to evolve, it will be important to address “bridge activities”, or those activities that result in integration or rework scenarios between functional areas. We are pioneering a new model for clinical data workflows that is in alignment with our cross-functional approach to Clinical R&D, we provide the following services that ensure electronic data and associated documentation is compliant with industry standards and agency guidances for electronic regulatory submissions:

  • Annotation of Electronic CRF (bookmarks, hyperlinks)
  • Creation of eSub-Compliant Database (core variables) – Current & Legacy Studies
  • Creation of Patient Profiles
  • Development of Data Definition Tables (DDT)
  • Verification of SAS Version 5 Datasets – Exact Match to DDTs
  • Evaluation of Legacy-Study Clinical Databases for Compliance with FDA Guidelines
  • Production of Publishable CSR Template
  • Development of Customized Style Guides
  • Submission Component Templates

For more information download PDF of Clinical Information Management Datasheet or Contact Octagon.