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Biostatistics & Statistical Programming
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Home / Services / Clinical Trials & Clinical Data Management / Biostatistics & Statistical Programming
Biostatistics & Statistical Programming
Statistical Services
Development of study protocols
Support in study design
Definition of study objectives and endpoints
Sample size determination and randomization plan
Statistical analysis strategy and methodology
Dedicated Phase I, BA/BE study support including pharmacokinetic (PK) analysis
Preparation of statistical analysis plans consistent with ICH guidelines
SAS programming
Statistical analyses and reporting of study results
Production of tables, listings and graphs in compliance with ICH guidelines
Validated software: SAS® 9.2 and WinNonlin 5.0.1
Clinical Data Management Services
Accutest offers clinical data management services in two forms
In conjunction with clinical trial services
As standalone services to international CROs
Ability to perform studies using Oracle ® Clinical 4.5.1, the industry standard clinical data management systems.
CDM team is proficient in executing a project since Standard Operating Procedures (SOPs) have been developed to meet local and global guidelines of clinical data management
Adherence to 21CFR Part 11
Exhaustive Discrepancy Management
Quality coding with Thesaurus Management System using WHO Drug and MedDRA
Assiduous double data entry
Complete documentation that includes Data Management Plan, Data Entry Guidelines, Data Handling Guidelines, Edit Check Specifications, Obvious Correction Document and Tracking Sheet as per project requirement
Successfully completed Clinical Data Management and Biostatistical analysis for DCGI regulatory study, CRF designing and Biostatistical analysis projects for Japan client
