biostatistics-icta

Biostatistics

ICTA biometry services to generate high-quality and reliable data for informed decision making.

Benefit from our high level biometry expertise which combines knowledge in standard and complex statistical methodologies applied to clinical R&D, real world evidence (RWE) studies, and database / big data analyses.

ICTA BRINGS EXPERIENCE AND
EXPERTISE IN BIOSTATISTICS FROM THE STUDY CONCEPTION TO THE
PACKAGE SUBMISSION TO AUTHORITIES

We DRAW on our in-depth knowledge of STATISTICAL methodologies
to come up with approaches IN LINE WITH your project needs, regardless of THEIR complexity

Guidance in a wide range of study designs and implementation:

From “traditional” designs to adaptive designs (group sequential designs, continual reassessment methods, multi-arm multi-stage designs, adaptive randomisation, adaptive dose-ranging, seamless phase I/II, seamless phase II/III)

  • With a frequentist or a Bayesian approach
  • Cross-sectional epidemiological studies, cohort studies, case-control studies
  • Studies on medical devices, including evaluation of diagnostic methods

Writing of the statistical sections of protocols in conformity with the relevant guidelines

  • ICH E9 / ICH E9 (R1) for exploratory and confirmatory studies
  • Guidelines for bioavailability and bioequivalence studies
  • ENCePP Guide on Methodological Standards in Pharmacoepidemiology
  • EMA Guidance for the format and content of the protocol of non-interventional post-authorisation safety studies
  • HAS protocol template for post-registration studies for drugs, medical devices and health services

Design and implementation of sampling and randomisation plan

  • Sampling plan to select sites and patients to ensure the generalisation and extrapolation of the results
  • Programming of static randomisation lists
  • Definition and implementation of algorithms for dynamic randomisation

Analysis plan including

  • Population/analysis dataset definition and/or estimands definition
  • Procedures for handling missing data
  • Development of comprehensive statistical primary and secondary hypotheses description, statistical tests and models
  • Rules for computing derived variables
  • Mock tables, Figures and Listings (TFL)

Statistical programming using validated standard macro and programs and customized programs

  • Programming of derived datasets: CDISC Analysis Data Model (ADaM) format or non ADaM format
  • Programming of TFL, tested and fully validated according to the study risk
  • Overall quality controls of TGL in close collaboration with the ICTA Medical and Scientific Affairs department to guarantee the relevance and robustness of the study results

Interpretation and enhancement of results

  • Interpretation of study results and assistance in writing study reports, abstracts, posters and manuscripts.
  • Sensitivity/robustness analyses
  • Exploratory analyses

Integrated Summary of Safety and Integrated Summary of Effectiveness (ISS/ISE) for FDA submission

Expertise in data management and analysis of big and/or non-structured data

  • Data mining
  • Machine learning
  • Data visualisation
  • Artificial intelligence and prediction
ICTA Biometry

ICTA can provide with medical, methodology and statistical experts to coordinate and/or participate (as voting or non-voting members) to Independent Data Monitoring Committees (IDMC) or Data Safety Monitoring Boards (DSMB).

Other services

Design

Design

A close collaboration of scientific writers and biostatisticians to design your research project and communicate…

Regulatory affairs

Regulatory affairs

To help you successfully navigate regulatory hurdles. Always up to date on the latest regulations…

Project management

Project management

A strong and centralised project management organisation supported by a robust IT platform. Centralised at…

Site Support

Site Support

Do you need experienced Clinical Research Assistants to assist you? Our Clinical Research Assistants /…

Risk-based monitoring

Risk-based monitoring

An agile approach to improve data quality, ensure study continuity and reduce site burden. We…

Vigilance

Vigilance

A wide range of safety services for your clinical research projects

Data management

Data management

Our Data Management team’s motto can be summed up in 5 words: QUALITY, DATA INTEGRITY,…

Biostatistics

Biostatistics

ICTA biometry services to generate high-quality and reliable data for informed decision making. Benefit from…

Medical writing

Medical writing

ICTA offers a range of flexible medical writing solutions to support your clinical program needs…

RGPD compliant
21 CFR Part 11 compliance
Ecovidis 2022
crédit d'impôt recherche
bureau veritas certification icta
bureau veritas certification icta