Clinical Data Management Services
BIOPHARMA

Clinical Data Management Services

Makrocare provides customer with centralized, coordinated data management services for local and international studies. We handle all phases of clinical research across the full spectrum of therapeutic areas. MakroCare develops flexible and customized data management plans to accommodate each customer specific study needs. We also offer customized reports to customers at timely and periodical intervals to get the complete feel of the conduct of study.

CDM Team's Expertise at MakroCare

With vast global experience in managing data for all phases, MakroCare can collaborate with customers to efficiently manage clinical trial data and helps to meet desired business objectives in a cost-efficient manner, both tactically & strategically.

Our Team comprises of a pool of highly talented data managers from CRO industry with vast experience who are well trained in ICH-GCP and GCDMP with work exposure across the therapeutic areas having expertise in handling clinical trial data from Phase-I to Phase-IV studies for Submission to Regulatory bodies (Local and International).

MakroCare CDM Services Overview:

Study Set-up

  • CRF Design
  • eCRF Specification
  • CRF Annotation
  • eCRF build
  • Data Management Plan
  • Data Base Design & Setup
  • Edit check specifications & Programming
  • Data Loading Setup
  • Dictionary setup (MedDRA, WHODD)
  • IVRS/IWRS Integration

Study Conduct

  • Data Review & Query Management
  • Medical Coding
  • SAE Reconciliation
  • Third party Data Reconciliation (Central Lab, eDiary, Pharmacokinetics etc.)
  • Post Production Change Control
  • Data Base Design & Setup
  • Standard & Customized Reports for Data review & Metrics
  • Data Transfer

Study Close Out

  • Interim analysis readiness
  • Final DB lock readiness
  • QC of Data Base
  • Database Audit by QA
  • Database Lock
  • Conversion of Data to SDTM or sponsor standards
  • Data Transfer
  • Study closure Documentation
  • Study Archival / Decommissioning

MakroCare CDM Advantage:

We at Makrocare have portfolio of Tools which benefits to deploy CDM solutions cost effectively. Our Services covers activities ranging from case report form (CRF) and database design to database lock and report submission.

Our tools constitute comprehensive electronic data capture system ‘mEDC’, advanced reporting system Clinmetanoia, Customizable CRF design application ‘Dattasa’ Centralized document management system ‘jarTree’.

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