Data Management

Our tools are extensively customised to meet your specific needs – both for paper-based and Electronic Data Capture (EDC) trials. Our systems, SOPs and staff will provide you with cost-effective, secure, regulatory-compliant and efficient data management services.

Efficient data management speeds the clinical trial process and ensures excellent data collection accuracy and consistency. We can meet all of your clinical data management needs.
Services:

• Selection of appropriate technology and processes for your study
• Case report forms (CRF)
• Design and database implementation
• Electronic Data Capture (EDC)
• ePro/eDiary systems
• Data validation and clinical programming
• Electronic data integration and transfer
• Data management plan and data validation plan preparation
• Dictionary preferred-term coding using MedDRA® and WHODD
• Data review
• Data management and systems audit

Biostatistics

Statistical Analysis is crucial to the success of any clinical trial. Which is why we always strive to provide you with quality services and solutions. Our experienced team of biostatisticians provide trial design consultation, statistical methodology recommendations, programming expertise as well as the reporting accuracy necessary to deliver your trial efficiently and on time.

Services:

• Study design
• Randomisation schedules
• Sample size calculations
• Statistical consultancy
• Statistical analysis
• Analysis, tables, figures and listings programming
• Statistical reporting
• Input into the integrated clinical/statistical reports
• Writing and reviewing of medical articles