A close collaboration of scientific writers and biostatisticians to design your research project and communicate…
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 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
Regulatory affairs
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Project management
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Site Support
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Risk-based monitoring
An agile approach to improve data quality, ensure study continuity and reduce site burden. We…
Data management
Our Data Management team’s motto can be summed up in 5 words: QUALITY, DATA INTEGRITY,…
Biostatistics
ICTA biometry services to generate high-quality and reliable data for informed decision making. Benefit from…
Medical writing
ICTA offers a range of flexible medical writing solutions to support your clinical program needs…
