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Data Management
Accutest also offers Clinical Data Management (CDM) services to its customers. The CDM services are offered in conjunction with clinical trial services and as a stand-alone service to global CROs. The Company's CDM services are offered on the Oracle Clinical 4.5.1 platform, the global benchmark for CDM services. SOPs have been developed to meet local and global guidelines of CDM and the services are offered in adherence to 21CFR Part 11. Accutest has successfully completed a CDM assignment along with a biostatistical analysis for a regulatory study commissioned by the Drug Controller General of India (DCGI). Additionally, the Company has successfully completed a Case Report Form (“CRF”) designing and Bio-statistical analysis project for a Japanese client.
 
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 system
 
Adherence to 21 CFR Part 11
 
Quality coding with thesaurus management system using WHO Drug and MedDRA