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Clinical Data Management and Statistics for Medical Devices

Makrocare provides customer with centralized, coordinated data management services for local and international studies. We handle all types of clinical studies 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 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 Industry who are well trained in ICH-GCP and GCDMP with work exposure across the therapeutic areas having expertise in handling clinical trial data for different studies for Submission to Regulatory bodies.

CDM Services Overview:

Study Set-up

  • Bullet CRF Design
  • Bullet eCRF Specification
  • Bullet eCRF build
  • Bullet Data Management Plan
  • Bullet Data Base Design & Setup
  • Bullet Edit check specifications & Programming
  • Bullet Data Loading Setup

Study Conduct

  • Bullet Data Review & Query Management
  • Bullet Medical Coding
  • Bullet SAE Reconciliation
  • Bullet Third party Data Reconciliation (Central Lab, eDiary, Pharmacokinetics etc.)
  • Bullet Standard & Customized Reports for Data review & Metrics
  • Bullet Interim analysis readiness

Study Close Out

  • Bullet Final DB lock readiness
  • Bullet QC of Data Base
  • Bullet Database Audit by QA
  • Bullet Database Lock
  • Bullet Data Transfer
  • Bullet Study closure Documentation
  • Bullet Study Archival

MakroCare CDM Benefits:

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


Our global clinical biostatistics and programming team offers a deep understanding of the science of disease areas along with devices and provides efficient upfront study design and comprehensive planning assistance.

Statistical Services:

  • Bullet Product development planning, Sample Size estimations, study design, and analysis, as well as supporting methodologies and statistical analysis plans
  • Bullet Clinical protocol development and Clinical study report review
  • Bullet Planning and implementing Study final and interim analysis
  • Bullet Publication support and Ad-hoc analysis

Statistical Programming Services:

  • Bullet Validated Macros bring efficiency, cost savings, and accelerated timelines.
  • Bullet Derived dataset production and validation
  • Bullet TLF production and validation
  • Bullet Regulatory submissions
  • Bullet Submission-ready datasets and programs

MakroCare statisticians, who are all at the Ph.D. or M.S. level, are familiar with regulatory requirements and skilled in robust statistical methodologies. Our statistical programmers are versatile and experienced in the use of SAS, enabling us to generate report summaries and listings to meet your specifications.

Expert full service Clinical Data Management (EDC or Paper), Biostastistics and
Statistical analysis services for Medical Devices studies

The First Step

Let's talk about how MakroCare can help you