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overview
in compliance with ich-gcp and in accordance with us fda 21 cfr part 11 regulations concerning the dm system, our data management and biostatistics services are tailored to fit your clinical trial needs. we employ advanced technologies, optimized processes and professional teams to meet specific requirements of each project. the excellent planning and abundant resources can ensure high quality data with strict timelines and budget constraints.
data management
• crf /source data collection design
• project training
• data management plan
• structure specification
• data validation plan
• annotated crf
• database design & verification
• data entry test
• crf retrieving & tracking
• visual/manual review
• data coding (meddra, who-drug) |
• data entry guideline
• double data entry & comparison
• data validation
• computer-aided logic check
• dcf issuing & tracking
• sae reconciliation
• routine progress report
• data review meeting
• data transfer with central lab
• database lock & data transfer
• document archiving |
biostatistics
• study design
• protocol & crf review
• sample size design
• randomization design & drug allocation
• programming & program validation using sas |
• pk analysis and bioequivalence analysis
• interim analysis
• statistical analysis plan
• statistical analysis report
• clinical study report writing support |
it support
a strong it system guarantees the safety of data storage and data transfer. we have remote backup system in beijing.
we have designed and implemented an effective quality control system to ensure each step is done in accordance with the high standards of our procedures. |
