Statistical Offerings
Consulting
Octagon’s team of Statistical Consultants offer the depth and breadth of therapeutic experience required to interact with regulatory authorities, assist clients in production of electronic submission-ready output and support the entire clinical data lifecycle from collection to submission.
Octagon’s Statistical Consulting Team offers the skilled people, refined processes and core technology required to provide a comprehensive solution.
Our statisticians produce analyses and reports for statistical elements of clinical trials with a solid understanding of regulatory submission requirements and CDISC data standards. Because of this unique foundational knowledge, clients frequently look to our experts for guidance and support for health authority interactions. Octagon’s Statistical Consultants actively lead and participate in industry initiatives and are frequently requested speakers at industry conferences.
Fulfilling your statistical needs for all regulatory filings as well as postmarketing efforts
Our highly qualified team partners with clients to provide the following deliverables:
- Development and implementation of departmental SOPs
- Input into the design and development of Case Report Forms (CRFs)
- Interim Analyses
- Statistical Analysis Plans (SAPs)(Study level, ISS and ISE)
- Analysis according to SAP
- Data analysis/meta analysis for regulatory submission
- Statistical guidance in Regulatory activities and discussions with health authorities
- Conduct customized statistical training based on specific client needs
- Publication strategy and support (abstracts, manuscripts, and posters)
