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CDM
Introduction
What We Offer
Business Need
Mithas Schools of Thoughts
 
Oracle Pharmaceutical Applications (OLS)
Oracle Clinical
Thesaurus Management System
MedDRA
WHO Drug
 
Mithas Labs data management unit needs to spend a lot in hardware, software, leased line connectivity and skilled people. The sponsors looking at the data management business through outsourcing from India expects the following from the service provider.

A detailed data management plan
Preparation of database in desired software
Comprehensive electronic validation and consistency checks
Data entry including double data entry
Query generation, handling, editing and tracking
Database lock
100% Quality Control of the efficacy parameters and safety data
21 CFR Part 11 compliant

Each Sponsor looks at “21 CFR Part 11” compliant software to be used for their data management. To ensure compliance to 21 CFR Part 11, Mithas should have proper clinical data management systems
with validated hardware and servers with proper performance, installation and operational qualification documentations with User acceptance test (UAT). This further necessitates the documentation of the training to the data management staff on servers, software, etc by a qualified team of professionals, for which Mithas shall establish a training setup on CTDMS for both in-house and outside participant which Infact a clear source revenue for Mithas.

 
 
 
Clinical Research
CDM – Data Management System for Clinical Research
PGDCR / MS in Clinical Research
LIMS - Laboratory Information Management Systems
Batch III PGDCR starting on 19th January 2009.
 
 
 
 
We have landed at our new CRO facility, for a sparkling start
 
 
 
 
Autoscribe UK has appointed Mithas Labs to further expand its network of business partners offering pre-sales and post-sales services for its successful LIMS, scientific and business software solutions and implementation across India.
 
 
 
 
Mithas Labs has chosen Oracle Clinical for CDM License.
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