Clinical data management
Transform your clinical data into actionable insights
Reduce errors, risks, and costs by ensuring quality and accuracy of clinical trial data for faster regulatory submissions
The success of a clinical trial depends on collecting and managing research data in line with regulatory standards for statistical analysis. Our Clinical Data Management (CDM) services ensure that your data meets regulatory quality assurance mandates, while also accelerating the development of pharma products.
At Inductive Quotient, our team of expert professionals comes with a deep understanding of the needs and challenges of clinical research. We design a customized CDM solution after learning your specific requirements to ensure high-grade data quality and precision.
Our approach begins with building a stack of tools and techniques to collect clinical data based on the study protocol, followed by a data validation process assuring compliance with regulations like ICH-GCP, CDASH, and other regulatory requirements. This clean data is sent for statistical analytics and programming to extract insights.
Our Services
- Plan
Preparing supportive study environment for the efficient management of clinical trial data via eCRF and setting up the database structure, user accounts, and access controls.
- DMP Preparation
- eCRF Design Specification
- Data Validation Plan
- Data Transfer Specification
- Edit Checks Specifications
- Protocol Deviation Plan
- Implementation
Regardless of therapeutic areas, indications and clinical trial phases, we implement our strategy for the therapeutic area and adaptive database design.
- Clinical Database Design (CDASH)
- Edit Checks Programming
- Database Validation (UAT) & Go Live
- SAE Notification Email Programming
- Database Integration with RTSM & ePRO
- Coding Setup
- Data Dictionary Versioning
- Site Training
- eCRF Completion Guidelines
- Conduct
Study conduct typically includes monitoring data accuracy, cleaning and reconciling data, and assisting study staff with data management issues.
- Data Validation
- Query Management
- SAE Reconciliation
- Safety Data Reconciliation
- Protocol Amendments
- Mid-Study Changes
- Subject Data review
- Discrepancy Management
- Lab Normal Range Management
- Data Reconciliation – Lab, & SAE
- Review Protocol Deviations
- Review Coding Queries
- Monitor study status
- Mid-Study User Acceptance Testing (UAT)
- Quality Assurance and Quality Check
- Source Data Verification
- Medical Coding – MedDRA & WHODD
- Database soft lock
- Perform Early Process Review
- Insightful Reporting
Generate insightful reports and information to properly assess performance and enhance decision-making so as to reduce discrepancies and maintain data integrity.
- Site Listing Reports
- Edit Checks Report
- DM Metrics
- Enrolment Report
- Protocol Deviation Report
- Query Summary Report
- User Audit Trail/Productivity Report
- Clean Patient Report
- Close Out & Archive
Ensure high-grade data quality in line with study protocol, SOPs, GCP and associated regulations mandated by the sponsor through an efficient flow of reconciliation, recording and reporting.
- Final Database Cleaning
- QC Check
- QA Check (10%)
- Generating subject data
- Database Hard Lock
- Export raw data to SDTM datasets as Excel, SAS7BDAT, txt, etc.,
- Revoking User Access
- Archival of all documentation
- Decommissioning URL
At IQA, we are uncompromising when it comes to data security and governance. We employ cutting-edge technology and security guidelines to safeguard your clinical data throughout clinical trial research.
Ensure the quality & integrity of your clinical data with us
At IQA, we’re committed to providing high-quality clinical biostatistics services that help to advance clinical research and improve results.