Biostatistical analysis

Biostatistics Services: Improving Reliability and Consistency of Clinical Trial Results

Our statisticians are able to implement both standard and innovative methods to provide results that are accurate, reliable and reproducible, using techniques that are required by the regulatory agencies. From helping to design a cost-effective, optimal clinical trial and providing the relevant statistical input on the study protocol to representation at meetings with regulatory authorities, our experts are there to support you on every step of the way.

Biostatistical Analysis and Regulatory (FDA-EMA) Support:

  • Our strong team of senior biostatisticians (including 9 PhDs, 1 ScD, 3 MDs, and 17 MScs) and statistical SAS programers produces high-quality, reproducible, timely analysis and reporting of clinical trial results across all therapeutic areas.
  • The biostatistics team, which accounts for a third of IDDI employees, is committed to providing the very latest statistical thinking. Therefore, we stay abreast of the latest statistical methods and related regulatory preferences. All of our statisticians and statistical programmers receive ongoing, intensive training inside and outside the company.
  • Our statisticians are experienced in interacting with the FDA/EMA and other regulatory agencies and pride themselves of effectively communicating on behalf of our Sponsors.
  • All clinical studies are performed in compliance with FDA and CDISC requirements.
  • Our SDTM/ADaM experts have the ability and experience in developing eCRFs to CDISC/CDASH standards and delivering data in STDM and ADaM standards.
  • The department also has extensive experience with Data Safety Monitoring Boards (DSMB), including charter development, safety and efficacy analyses, and conduct and documentation of DSMB meetings.

Comprehensive Biostatistics Services for the Success of Your Clinical Trials

NO MATTER THE COMPLEXITY OF YOUR CLINICAL TRIAL, WE CAN TAILOR A SOLUTION TO CLINICAL DATA ANALYSIS.
We use advanced clinical biostatistics, state-of-the-art techniques, and innovative study designs to support clinical trials in any phase of development in any therapeutic area.

  • Protocol design
  • Statistical Analysis Plan (SAP)
  • SAS Programming and Independent validation of tables, listings, and figures
  • Derived datasets
  • PK/PD analyses
  • Statistical report and appendices
  • Statistical input to publications
  • Validation or audits of biostatistics accomplished by others
  • Meta-analysis
  • Validation of surrogate endpoints
  • Exploratory analyses
  • Rescue studies
  • Biomarkers validation
  • FDA/EMA representation/assistance

Statistical Software:  SAS for Windows version 9.4, standard SAS macros for reporting, Excel and R for graphs, specialized software for sample-size calculation (EaSt®)

986
Phase I-IV trials
20
FDA/EMA approvals
7
Rescued studies
35
FDA/EMA meetings
208
DMCs