Statistics

Statistics

Expertise and knowledge make a significant difference

From the inception of your project to final reporting, statistical consultancy is key to ensuring the design of your study is fit for purpose, meeting all your clinical objectives. Our team of statisticians, consultants and SAS programmers offer you a breadth of industry experience across a wide range of therapeutic areas and trial designs as well as extensive experience of interactions with regulatory agencies, supporting both development planning strategies and expediting the approval process.

Working with you, they will advise on the most appropriate study design and prepare detailed, comprehensible and accurate Statistical Analysis Plans to ensure successful evaluation and reporting activities. The team will convert the plan into reality from quality programming of datasets though to outputs and reports.

More than just tables, figures and listings

We can also offer a consultative approach to adaptive clinical trial design methodologies providing greater flexibility as well as time and cost savings. Statistical representatives can be assigned to any Data Safety Monitoring Board and/or Steering Committee used in your study. Our statisticians can also assist you with interpretation of study results.

Our team of dedicated statistical programmers provide a high quality service in the development of all study data presentations employing internal or client standards. We also offer CDISC compliant delivery including data mapping/integration of multiple studies and legacy data to meet current regulatory reporting guidelines, as well as the creation of defines, reviewer’s guides and annotated CRFs.

Statistical planning or consultancy

Although we offer statistics as part of our integrated full service package, we can also provide a dedicated and focused stand-alone statistical consultancy and programming service to meet your specific development needs.

Noted industry statistical experts can support your development planning needs as well as providing advice on regulatory agency considerations. This can include expert interaction and meetings with agencies regarding planning and submission requirements.

Areas where we can help you

Our teams can support and guide you in many areas, including:

  • Protocol development
    • Sample size, statistical analysis, methodologies for avoiding bias etc.
  • Randomisation
  • Statistical Analysis Plan (SAP)
    • Detailed description of all statistical analyses and data summaries
    • Shell Tables, Figures and Listings (TFLs) based on internal or client standards
  • CDISC SDTM and ADaM datasets and associated documentation (define.xml, reviewer’s guides and SDTM annotated CRF)
  • Validated programming with delivery of 1st Draft TFLs prior to database lock
  • Data integration and meta-analysis, integrated summaries of safety and efficacy
  • Final TFLs, with key results delivered rapidly
  • Additional services include:
    • Development planning, study design and expert statistician consultancy
    • DSMB delivery
    • Interim analysis
    • Regulatory authority interactions and meetings

Integrated Summaries of Safety and Efficacy (ISS & ISE)

SQN has the experience of dealing with regulatory agencies to agree ISS/ISE strategy, and the flexibility to deal with client’s unique requirements for complex situations. We can provide expertise in dealing with the specific issues that an ISS/ISE can bring and appreciate the differences in the planning and conduct these projects compared to single studies based on our extensive experience.

We will work with you to understand your requirements, offer guidance, assess the individual studies. We will work with you to create the ISS/ISE plan, merge the required data and deliver the resulting analysis on time.

Specific areas of expertise include:

  • Rationale for robust study pooling strategy
  • Target patient population
  • Strategy for pooling treatments and follow-ups
  • Efficacy and safety endpoints
  • Statistical analysis methodology & presentation
  • Subgroups of interest
  • Design of the specific and often complex ISS/ISE style outputs
  • Specialists in the integration of datasets through:
    • Mapping of individual study data to CDISC SDTM and ADaM standards
    • Modification of ISS/ISE ADaMs to ensure they meet the specific requirements of the ISS/ISE reporting e.g. inclusion of additional subgroup flags.
    • Provision of SDTM and ADaM define.xml, associated data reviewer’s guides and SDTM annotated CRFs
    • Ensuring compliance to industry standards