- Randomisation
- Designing and producing electronic and paper case report forms (eCRF, CRF).
- Writing the data management part of the study protocol.
- Preparation of data cleaning plans (DCP).
- Entry of data (single, double).
- Implementation of the data cleaning process (DCF, DQF).
- MedDRA coding.
- Closing databases.
- Quality control.
Data management and biostatistical services are available for the following study types and needs:
Observational studies aimed at exploring the factors involved in diseases:
- case series study – only to study special cases
- case-control study – in the case of “what happened?” type questions
- cross-sectional study – to assess present status
- cohort study – in the case of “what will happen?” type questions
- Clinical trials to test the efficacy of therapies:
- uncontrolled (one-arm) – in the case of initial tests.
- controlled:
- parallel: open-label, blind, double blind
- internal control: self-controlled, crossover, historical control
Meta-analysis – where the effects of a drug or treatment were analysed in several studies, we summarise the results of such studies in a statistically exact way. In addition, unknown but relevant relationships can be identified from a large data pool with the aid of data mining.