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Lotus Clinical Research Academy Pvt. Ltd. (LCRA)'s Clinical Data Management Services: LCRA offers comprehensive data management services with statistical and medical writing services for early clinical development and late phase clinical development services.

LCRA uses Oracle Clinical platform for executing CDM services and the software is fully validated and compliant with US FDA guidelines. LCRA has installed the following life science products of Oracle to support data management services


  • Oracle Clinical 4.5 - for Clinical Data Management
  • Oracle Remote Data Capture(RDC) - for data capture at clinical trial sites
  • Oracle Thesaurus Management System(AERS) to support Pharmacovigilance
  • Oracle Clinical Trial Management System 8.0 (CTMS) for project tracking including clinical supplies

LCRA has subscribed to MeDRA, V 12.0 to facilitate coding work as per international guidelines.

Our CDM services include:


  • Database study design and study set up
  • CRF Designing and Annotation
  • Data Capture
  • EDC
  • Paper CRFs
  • Data Management Plan
  • Data Entry & Validation Procedures
  • Double Data Entry
  • Medical Coding
  • Query Management
  • SAE Management
  • External Data Load
  • CDISC Compliant Data Transfer
  • Database lock and close out
  • Data Extracts
  • Data Archival
  • Statistical Analysis Plan development
  • Statistical Analysis
Click here to Download our Clinical Data Management Brochure
 
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