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

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

Study Conduct

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

Study Close Out

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

MakroCare CDM Benefits:

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

Statistics

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:

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

Statistical Programming Services:

• Validated Macros bring efficiency, cost savings, and accelerated timelines.
• Derived dataset production and validation
• TLF production and validation
• Regulatory submissions
• 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.