Data & Biometry

Outsourcing of your biometrical activities to PHARMALOG as an Expert in Clinical Research Resources and Manpower

Team of eight Experts:

• Three biometricians, five data managers, additional data entry personnel
• Close contacts with statisticians at universities
• Data management according to your or PHARMALOG's SOP

Data Management:

• Streamlining protocol, CRF and database from the datamanager's perspective
• Developing "Data Management Plan" (DMP) and "Data Validation Plan" (DVP)
• Database set-up and data entry according to 21 CFR Part 11
• Coding according to ICD, WHO or MedDRA
• Data import of lab data or other external data
• Automatic data query management
• Preparing and conducting the "Blinded Report Meeting"
• Valid statement and database closure
• Data transfer and archiving

Biometry:

• Principle statistical design considerations
• Sample size calculations
• Randomisation
• Statistical element of the protocol tailored to the aim of the trial
• Planning adaptive designs and performing interim analysis
• Setting up and finalising the "Statistical Analysis Plan" (SAP)
• Statistical analysis (SAS) and appropriate statistical reporting of the results (biometric report)