Our Services

We implement CDISC standards and can help customers to adopt these standards in their clinical databases/Global repository for collecting and reporting data to the authorities.

The FDA is looking favorably at the CDISC initiative and more and more companies in the Pharmaceutical industry are adopting this standard.

We can also provide Project Management, co-ordination between Sponsor and CRO/3rd Party. We work in close partnership with our Clients to provide high quality transparent services to exceed our Client´s expectations.

Please contact us for further details to discuss your requirements and to find a customised solution for you.

We offer customised solutions to CROs and pharmaceutical companies:
Review of clinical study protocols according to GCP and local SOPs
Design of paper-based case repord forms (CRF) of a given protocol
Programming of (non-paper) electronic CRFs of a given protocol
Database design of clinical studies
Development of sophisticated data entry programs eliminating double-data entry
Design of corporate safety database
Perform data entry from CRFs - extracting safety data for corporate safety database
Computer-aided coding of medical terms such as diagnosis, medication, adverse events
Data cleaning, preparing queries and providing support for resolving data collection shortcomings
Statistical evaluations, statistical reports
Writing of final study reports

Other services offered by Datagen:
Conversion of data formats e.g. from a non-standard clinical study DB to a standard DB format
General (relational) database design
Windows application programs (custom software development)
Development of models for decision analysis
Computer simulations (Monte Carlo simulation, clinical and economic modeling)
Biostatistics, consulting and statistical testing
Particular statistical analysis: meta analysis, bootstrap method, Fisher's exact test
Literature synthesis and meta analysis
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