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Accenture is a Diamond-level Sponsor and Registered Service Provider of CDISC

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Clinical Programming

In every engagement and every deliverable, Octagon's clinical programming experts produce high quality, submission-compliant analysis data and statistical output that ensures swift and efficient agency reviews. Octagon's extensive technical know-how, industry-leading CDISC standards expertise, and FDA relationships reduce your risk of compromised study timelines, helping you launch emerging breakthroughs on budget and on plan.

Octagon provides clinical programming services across a broad range of therapeutic areas that include CV, CNS, Oncology, Endocrinology, GI, Respiratory, Vaccines, Medical Devices, Imaging, among others.

Our clinical programmers provide experience in all phases of drug development ranging from pre-clinical, Phase I through Phase IV trials, integrated analyses, Data Monitoring Committees (DMC), regulatory submission activities and support of Publication strategies.

Octagon's Clinical Programming services include:

  • Submission-Compliant Analysis Datasets incorporating ADaM and traditional SDS v1.6 standards
  • Pharsight Phoenix WinNonLin v6.1
  • Tables, Listings and Figures (TLFs) in support of global regulatory submissions
  • Pooled data analyses for ISS and ISE deliverables
  • Submission-compliant analysis dataset documentation defined in Data Definition Tables
  • Incorporating ICH compliant analysis strategies
  • All Programming deliverables based on written validated specifications
  • Independent quality validation of all programming deliverables
  • Execution of data warehouse and safety database conversions
  • Conversion of legacy data to today's submission-compliant ADaM standards
  • Validation of sponsors ADaM standards to ensure submission compliance
  • Collaboration with medical writers and clinical scientists

Client-Focused Programming Teams

Our dedicated clinical programming teams are focused on sponsor needs, timelines and client-specific analysis standards. We have the flexibility to support aggressive timelines, project priorities and various business models, and work closely with our clients, facilitating collaborative, proactive communication.

Excellent Staff Retention and Training

Octagon works to ensure that we retain our talented professionals to facilitate continuity on client projects from start to finish. All of our statistical programmers receive ongoing, intensive training that ensures compliance to industry and regulatory agency standards such as 21 CFR Part 11; CDISC ADaM specifications, GCP and ICH standards; SAS® software programming skills; statistical methodology; complex randomization procedures, and other areas.

 

"I feel very connected and in-sync with my Octagon counterparts. They're always there to answer questions whenever they're called upon. We’re not a large pharma company but I feel like we’re treated the same."

Emerging Biopharmaceutical Company