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

• 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:

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