Our Data Management department, is headed by Mr. Manfred Gellert who is part of the team for more than 15 years. He is supported by his staff of data managers and data entry personnel.

All of our data management procedures are defined in SOPs and study specific documents like the data management plan. As data management software we use the software Clintrial ® that is running on a computer system that is validated in compliance with regulatory requirements and international standards.

The services include:

• Preparation of the Data Management Plan
• Design and validation of the Database
• Double data entry
• Electronic data capture (if provided by sponsor)
• Cleaning and validation of data query management
• Generation of data listings
• Program checking
• Data transfer
• Data coding using standard thesauri and MedDRA ® (e.g. ICD-10, WHO-ART, WHO-DRL) and custom dictionaries.