Micro Therapeutic Research Labs Private Limited - Science with Ethics
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We Serve Science with Ethics
Bioavailability / Bioequivalence
Bioanalytical
Clinical Trials
Clinical Data Mgmt
& Biostatistics
 
Pre-clinical
Diagnostic Laboratory
Clinical Data Management & Biostatistics

 

CDM tool:

Data management runs on internationally approved and validated CDMS, SAS Pheedit 3.0 which undergoes exhaustive quality control testing and quality assurance oversight from CRF design through database lock.

 

CDM services, 

  • Protocol design and review

  • Case Report Form (CRF) design, review and production.

  • Database design

  • Data entry

  • Data validation/verification

  • Medical review.

  • Medical term coding.

  • Lab Data transformation from non-central Laboratories.

  • Quality management procedures

 

Biostatistics services,  

  •  Design, Randomization, Sample size calculation

  •  Data manipulation

  • Statistical Analysis

  • Periodic data monitoring and safety reviews (DSMB)

  • Unscheduled interim analyses

  • Post-hoc and exploratory analyses

  • Formal interim and final analyses

  • Statistical consulting

 

CDM Infrastructure,

  • A robust IT infrastructure is in place to ensure complete accountability of the data being processed with validated 24 × 7 physical and data security, redundant power and internet connectivity

  • Dedicated IT and DBA support

  • Data backup and Disaster recovery policy.

  • SAS Pheedit 3.0

  • SAS 9.1.3 for Data Analysis

  • Business Object (Crystal reports) 11.0 for CDM reporting

  • WinNonlin® 5.2,Kinetica 4.4.1 for Pharmacokinetic Analysis

  • MedDRA for Medical coding

  • WHODD for drug coding

   
 
 
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