Accurate and Reliable Clinical Data Management
At MTRL, we recognize the significance of precise and dependable clinical data management throughout the entire drug development phase. With over 19 years of industry experience, we ensure the highest levels of data quality and integrity for your clinical trials.
Our expert team handles every aspect of CDM, from initial database design through final analysis, ensuring strict compliance with Good Clinical Practice (GCP) guidelines and international standards.
Our Comprehensive Clinical Data Management Services
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EDC System Design & Implementation
Setting up Electronic Data Capture (EDC) systems, including utilizing industry-standard platforms like Oracle Clinical and SAS.
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Case Report Form (CRF) Design
Development and refinement of both paper and electronic CRFs to ensure efficient data collection.
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Database Lock & Archiving
Finalizing the clinical trial database and securely archiving all data in compliance with regulatory requirements.
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Data Validation & Cleaning
Implementing stringent data validation checks and query generation to guarantee accurate and clean data.
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Data Analysis & Reporting
Generating statistical summaries and reports, preparing data for bio-analytical and medical writing teams.
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Study Progress Management
Providing regular updates and progress reports throughout the clinical trial process to ensure transparency.
We maintain the highest levels of accreditation, including full compliance with Good Clinical Practice (GCP) guidelines and certifications from the International Organization for Standardization (ISO) and the Drug Controller General of India (DCGI). This commitment ensures your data is globally accepted and submission-ready.
Choose MTRL for your Clinical Data Management needs and experience the peace of mind that comes with working with a trusted and experienced partner in the pharmaceutical industry. We work closely with our clients to ensure that their specific needs are met, and provide regular updates and progress reports throughout the clinical trial process.
Streamline Your Clinical Trial Data Process Today
Contact us to learn how our expert CDM team can ensure your data is accurate, reliable, and regulatory compliant.
Request a CDM Consultation