Cloud-Based Solution for Clinical Trials & Data Management
Clinical Research LIMS is a cloud-based Laboratory Information Management System (LIMS) designed specifically for clinical research laboratories. This powerful platform streamlines the management of clinical trial data, sample tracking, and regulatory compliance, helping organizations optimize their research workflows and enhance data accuracy.
Key Features of Clinical Research LIMS:
Cloud-Based Accessibility:
Access your LIMS from anywhere with internet connectivity, enabling real-time collaboration and remote monitoring of clinical trial data, samples, and results. This flexibility improves efficiency across your team and research partners.
Comprehensive Sample Tracking:
Effectively manage biological and clinical samples, ensuring accurate tracking from collection through testing and storage. Clinical Research LIMS supports detailed sample logging, barcode integration, and automated tracking to minimize errors and improve reliability.
Regulatory Compliance:
Clinical Research LIMS ensures compliance with critical regulatory standards, including 21 CFR Part 11, GxP, and ISO 9001:2015. Built-in compliance features support audit trails, digital signatures, and real-time adherence to clinical trial protocols.
Integrated Data Management:
The system integrates with laboratory instruments, data sources, and clinical trial management systems (CTMS), allowing seamless data flow and centralized management. This eliminates data silos and streamlines workflows from sample collection to reporting.
Advanced Reporting & Analytics:
With customizable reporting tools, Clinical Research LIMS enables easy generation of reports for clinical trials, data analysis, and regulatory submissions. Track trends, monitor sample statuses, and evaluate key performance indicators to optimize research outcomes.
Automated Workflows:
Automate routine tasks such as sample processing, result entry, and reporting to reduce manual effort and human error. Customizable workflows ensure consistency and improve efficiency across clinical research studies.
Quality Assurance & Control:
The platform includes built-in quality control (QC) and quality assurance (QA) functionalities, such as automated test validations, equipment calibration management, and sample result comparison, ensuring high data integrity and reliability.
Client & Investigator Portal:
Offer real-time access to clinical trial data and results through a secure, customizable portal. This portal allows stakeholders, including sponsors, investigators, and clients, to track progress and access results on-demand.
Real-Time Data Security & Integrity:
Clinical Research LIMS prioritizes data security with robust encryption, secure logins, and digital tracking of user activities. The system maintains the highest standards of data integrity, ensuring compliance with industry regulations.
Compliance Requirements
- ICH GCP
- HIPAA
- FDA 21 CFR Part 11
- EU Clinical Trial Regulation
- GCLP
Key Functionalities
- Clinical trial sample management
- Subject data privacy protection
- Study protocol management
- Trend Analysis
- Training and Competency of Laboratory personnel
- Manage Instrument maintenance and Calibration
- Document Management
