Data Management and Biostatistics

Biofortis offers you expert data management tools and statistical services to ensure the reliability of your study data and the creation of a relevant database for final analysis.

Some of our key tools and services:

- Electronic CRF and other internationally recognized digital tools to optimize accuracy and quality of study findings

- Standardized statistical analysis tools to demonstrate efficacy

- On-site clinical research associates personally control, collect and transmit data for processing

- Coordination of international teams to ensure seamless data management

- Meta-analysis and customized analyses according to needs

Clinical Data Management

Biofortis offers data management tools to ensure the reliability of data in your studies and achieve a relevant database for the final analysis. Our data management team can assist you with all or part of the process of data
management in a controlled environment.

CRF design: Recovery documents of relevant data according to your standards or ours

Data entry screens / Database design:

• CRF paper replica

• Annotated CRF

• Data dictionary

Data collection:

Data entry:

Our in-house data capture tool allow us to manage standard data entry (CRF paper) and/or online data entry (eCRF)

• Double data entry (2 different data entry operators)

• Simple data entry and monitoring by CRA

• Data entry rules and data entry operator training

• Management of users and access rights

• CRF Tracking: receipt, form control, data entry

• Quality control

Data import

• Non clinical data (life style, etc.)

• Laboratory results

Data control

• Data validation plan

• Edit checks

• Queries roster

• DCFs (tracking of edition, sending and receipt)

Data export: support of different formats: xls, csv, SAS, Flat file

Data review

• Meeting

• Report

• Database lock

• Unblinding


Our biostatistics team is involved from the earliest phases of your project. We can provide insights into your clinical trial design, help you define study outcomes and identify potential sources of bias. Our biostatisticians can help
you to calculate an adequate sample size for your study and ensure you achieve a desired power for correct detection of the expected clinically relevant effect at a given significance level. Our team also offers its experience in generating a
randomization schedule, an essential study design step to minimize allocation bias in treatment assignment.

Biostatistical analysesOur highly trained group of biostatisticians provides a full range of statistical services following GCP-ICH standards, including:

  •    Consultancy in biostatistical methodology, advising you on the most appropriate methods or liaising with your internal biostatistics team to ensure that your objectives are met
  •    Writing of statistical parts of the protocols and Statistical Analysis Plan (SAP)
  •    Participation in data quality control steps and blind data review meetings
  •    Statistical modeling and programming
  •    Support in writing of scientific papers
  •    Independent audit of your programs and analyses
  •    Support in statistical input to responses to questions from Regulatory Authorities
  •    Meta-analyses: combining results from different studies, applying alternative statistical approaches to assess consistency between trials, identify subgroups of interest or draw new conclusions about the effectiveness of the study product.

Our biostatisticians can also be involved in analyses of data from many areas such as observational studies, R&D, laboratory method validation, genomics….

Our SAS-certified biostatisticians are fully trained in standard and advanced statistical methodologies: parametric and non-parametric approaches, mixed models, Generalized Estimating Equation (GEE) models, multiplicity issues, survival analyses, etc.