Contact Us Global Achievements

Clinical Programming Services

Octagon’s clinical programming team is differentiated from traditional clinical service providers because we leverage the efficiencies inherent to Clinical Data Interchange Standards Consortium (CDISC) electronic submission data standards.  We employ extensive Study Data Tabulation Model (SDTM) domain and Analysis Data Model (ADaM) dataset knowledge in every engagement to aide in enhancing deliverables and minimizing rework.  Our expert staff are CDISC members and active participants in CDISC initiatives, positioning Octagon as the industry experts in eSubmission data requirements.  Our leadership and participation in Pharmaceutical, National, Regional, and local SASCP user groups allows our clinical programming team to actively monitor changes within the Clinical Research and Development landscape.  As leaders in the industry we have conducted many training sessions and authored numerous articles, presentations, white papers and books on programming, validation and CDISC standard topics.

Clients benefit from our comprehensive experience and expert project planning as it reduces the risk of compromised study timelines and errors.  Our expert programming team analyzes and reports clinical study data across a broad range of therapeutic areas.  We have experience in many therapeutic areas, including but not limited to CV, CNS, Oncology, Endocrinology, GI, Vaccines, medical devices and imaging. Our clinical programmers have experience in all phases of drug development including pre-clinical, Phases I through IV and integrated analyses (ISS, ISE, etc.)

Quality Deliverables, Global Standards

Our clinical programming team is experienced in all phases of global clinical trials, facilitating consistency of standards and quality. Our working practices include:

  • Programming based on written specifications
  • Independent quality validation of formal deliverables to verify accuracy and audit readiness
  • Senior statistical review of all table, listing and figure (TLF) deliverables
  • Data Definition Tables (define.pdf and define.xml) for regulatory submissions

Complete, Concise TLF Reporting

Based on a well-developed plan, our clinical programming team provides our sponsors with timely, high-quality deliverables.  We ensure complete, high quality TLFs through:

  • ICH compliant analysis strategies
  • Production of tables, listings and figures that are submission-ready at delivery for medical writing
  • Interpretation and consultation of the CDISC ADaM data standard
  • Creation of pharmacokinetic parameters from pharmacokinetic concentration data, including analysis parameters (AUC, Tmax, Cmax, etc.)
  • Execution of data warehouse and safety database conversions
  • Collaboration with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results

Client-Focused Clinical Programming Teams

Our 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.

Expert Clinical Specialists

Octagon’s clinical programming team has a broad range of therapeutic experience, and programmers hold advanced degrees.  All of our statistical programmers receive ongoing, intensive training that incorporates:

  • Industry information such as 21 CFR Part 11
  • GCP and ICH standards
  • SAS® software programming skills
  • Statistical methodology
  • CDISC SDTM
  • CDISC ADaM

Team members are also current with industry standards and market trends, such as CDISC models.  Our biostatistics data are generally formatted to CDISC SDTM and ADaM standards for consistent reporting to clients and regulatory authorities.

Comprehensive Experience, Tailored Clinical Programming Services

Octagon's extensive clinical programming services can be tailored to meet the needs of your project:

  • Program development for individual studies and the formulation of analysis strategies and supporting methodologies consistent with ICH guidelines
  • Detailed statistical analyses according to sponsor's specifications and approval
  • Randomization schedules created and managed to ensure integrity of treatment masking
  • Scientifically-sound interpretation and reporting of results and efficient production of analysis summaries
  • Analysis of epidemiological endpoints, patient reported outcomes, e-Narratives and patient profile reporting
  • SAS Application programming: Tables, Figures, and Listings
  • SAS Transport File Development and Validation
  • Integrated Summary of Safety
  • Integrated Summary of Efficacy

For more information Contact Octagon.