Data Management and Statistics
Data Management
We manage all aspects of data management, in accordance with the Data Management Plan, ensuring accurate data and timely completion of the clinical database.
Our collaborators have many years of experience, working in all stages of data management, from database creation, to database depuration, query management and database closure.
Our clinical databases and software are validated in compliance with European, ICH and FDA standards. The latest applicable versions of SAS® programs are always used in the clinical trial.
Our services include:
- CRF development (including diaries, manuals, Quality of Life assessment forms)
- Data management project set-up (Data Management Plan, Data Validation Plan, Data Entry Guidelines)
- Database set-up and validation using CDISC standards
- Programming of data validation checks
- Electronic Data Clarification Forms, and Interactive Remote Monitoring systems for CRAs
- Data entry, verification and validation
- Coding of adverse event, concomitant medication etc in MEDRA or WHODRUGS
- Remote Data Entry Systems: we work either with commercial software (InForm, ClinTrials), or with our own EDC System
Statistics
The right data analysis is fundamental for study success. A carefully designed analysis plan is an essential prerequisite to a thorough analysis through accurate interpretation of the study data. Biostatisticians at Infociencia have the experience necessary to develop a statistically rigorous and customized plan for each project.
An understanding of the medical and clinical issues follows from reviews by our project team. Statistical programmers at Infociencia execute the plan, producing report ready analysis tables, data listings and figures for interpretation and inclusion in your study report or submission. A thorough quality review process ensures that all analyses are accurate and complete.
Our biostatisticians bring critical thinking that is highly desired by clients throughout the filing process. Our statistical programmers bring a wealth of knowledge of the latest programming techniques and features of the SAS system and other statistical software packages, a library of standardized and tested templates, as well as attention to detail, to deliver high quality, dependable analyses.
Biometrics Activities:
- Analysis planning
- Interim analysis planning
- Data Monitoring Committee (DMC) statistical support
- Randomization schedule preparation
- Statistical programming using SAS™, SAS/QC™, StatXact™, and SPSS
- Logic check programming
- Survival modeling
- Longitudinal modeling
- Exploratory Analyses
- Statistical reports
To learn more about this service, please contact us at masinformacion@infociencia.com