Clinical Data Management (CDM)

Accurate and Reliable Clinical Data Management

01Clinical Data Management

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.

From initial database design through final analysis

Clinical data, clean from day one

Features

19+ Years
Full Data Lifecycle
Accreditation

Experience

19⁺Years of industry experience

GCPEvery study

Oracle · SASIndustry platforms

Data quality and integrity

With over 19 years of industry experience, we ensure the highest levels of data quality and integrity for your clinical trials.

EDC system designEDC
Paper & electronic CRFsCRF
Study progress managementReports

Every stage, one team

EDC and CRF design, stringent validation and cleaning, database lock and archiving, and analysis-ready data for the bio-analytical and medical writing teams.

Accreditation

GCP
ISO
DCGI

Globally accepted, submission-ready

Full compliance with Good Clinical Practice guidelines and certifications from ISO and the Drug Controller General of India.

02Services

Our Comprehensive Clinical Data Management Services

EDC System Design & Implementation

Setting up Electronic Data Capture (EDC) systems, including utilizing industry-standard platforms like Oracle Clinical and SAS.

Case Report Form (CRF) Design

Development and refinement of both paper and electronic CRFs to ensure efficient data collection.

Database Lock & Archiving

Finalizing the clinical trial database and securely archiving all data in compliance with regulatory requirements.

Data Validation & Cleaning

Implementing stringent data validation checks and query generation to guarantee accurate and clean data.

Data Analysis & Reporting

Generating statistical summaries and reports, preparing data for bio-analytical and medical writing teams.

Study Progress Management

Providing regular updates and progress reports throughout the clinical trial process to ensure transparency.

03Accreditation

Globally Accepted, Submission-Ready Data

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.