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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 deep 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 experienced data managers from CRO and BioPharma industry 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.

MakroCare CDM Services Overview:

Study Set-up

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

Study Conduct

  • Bullet Data Review & Query Management
  • BulletMedical Coding
  • BulletSAE Reconciliation
  • Bullet Third party Data Reconciliation (Central Lab, eDiary, Pharmacokinetics etc.)
  • BulletPost Production Change Control
  • Bullet Data Base Design & Setup
  • BulletStandard & Customized Reports for Data review & Metrics
  • Bullet Data Transfer

Study Close Out

  • Bullet Interim analysis readiness
  • Bullet Final DB lock readiness
  • Bullet QC of Data Base
  • BulletDatabase Audit by QA
  • BulletDatabase Lock
  • BulletConversion of Data to SDTM or sponsor standards
  • Bullet Data Transfer
  • BulletStudy closure Documentation
  • BulletStudy Archival / Decommissioning

MakroCare CDM Advantage:

  • Bullet Global experienced teams to leverage from
  • Bullet Technology for CDM analytics and centralized reporting/monitoring
  • Bullet Fit-for-purpose models and costing
  • BulletTam well versed with industry standards like CDASH, SDTM and others
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