Clinical Trial Management System for Regulated Research Workflows
Manage complex clinical trial operations, bioequivalence studies, and compliance-heavy research workflows with a purpose-built CTMS integrated into your LIMS.
LIMSXL:- Control the complexity of regulated research with a trusted
clinical trial management system
Clinical trials are not just studies, they are tightly regulated, documentation-heavy workflows requiring complete traceability across subjects, visits, approvals, and outcomes.
Our software extends beyond routine laboratory operations to function as a Clinical Trial Management System (CTMS) for organizations conducting &higlighttxt;clinical trials, bioequivalence studies, and regulated clinical research&:higlighttxt;.
From screening to study closeout:- Our CTMS helps research teams reduce manual tracking, &higlighttxt;ensure audit readiness, and maintain full lifecycle control&:higlighttxt; by unifying trial management with robust LIMS architecture.
Clinical research organizations face these challenges
Fragmented tracking across studies and sites
Multiple protocols, sponsors, and trial phases create operational complexity.
Manual identifier management
BEQ, Study, Subject, Screening, and Enrollment IDs are often handled in spreadsheets.
Regulatory pressure and inspection risk
Missing approvals, incomplete records, or weak audit trails create compliance exposure.
Volunteer and subject confidentiality gaps
Participant data requires controlled access and structured tracking.
Visit-wise workflow complexity
Maintaining protocol adherence across multiple visits is difficult without structured systems.
Document chaos during audits
Retrieving consent forms, approvals, and volunteer records becomes painful under inspection timelines.
Key features of LIMSXL clinical trial management system
Comprehensive Study, Subject, and Identifier Management
Manages all critical clinical trial identifiers in a controlled, auditable structure.
- &higlighttxt;BEQ number management&:higlighttxt; for bioequivalence studies
- &higlighttxt;Study number tracking&:higlighttxt; across sponsors and protocols
- &higlighttxt;Subject and volunteer numbering&:higlighttxt; for confidentiality and traceability
- &higlighttxt;Screening IDs&:higlighttxt; to retain eligibility and screen failure records
- &higlighttxt;Enrollment IDs&:higlighttxt; for longitudinal participant tracking
Every identifier is linked systematically, enabling full visibility into the participant and study journey.
Purpose-Built for Clinical Trials and Bioequivalence Studies
Clinical trials demand far more than sample processing, LIMSXL supports regulated research workflows through-
- &higlighttxt;Centralized management&:higlighttxt; of clinical and bioequivalence studies
- End-to-end traceability from screening to completion
- Secure subject data handling with &higlighttxt;role-based access&:higlighttxt;
- Accurate linkage between studies, visits, outcomes, and documentation
No critical data point is lost, duplicated, or handled outside approved workflows.
Regulatory and Ethics Compliance Built Into Daily Operations
Clinical trials operate under strict oversight. Our software embeds compliance directly into workflows, supporting
- &higlighttxt;IEC approval number tracking&:higlighttxt; per study and site
- Structured retention of screening and enrollment records
- &higlighttxt;Controlled access&:higlighttxt; to sensitive trial data
- Full audit trails &higlighttxt;aligned with NABL and &:higlighttxt; &link-https://www.icmr.gov.in/;ICMR&:link-https://www.icmr.gov.in/; &higlighttxt;expectations&:higlighttxt;
This reduces compliance burden and keeps organizations inspection-ready.
Structured Trial Data Across Visits and Protocols
This solution captures trial metadata in a searchable, standardized format.
- &higlighttxt;Volunteer demographics&:higlighttxt; and identification
- Study and protocol references
- &higlighttxt;Visit-wise tracking&:higlighttxt; with visit numbers
- ICD and language version control
- Bioequivalence and trial-specific parameters
Research teams gain consistency, visibility, and control across trials.
Volunteer-Centric Document Management for Audit Readiness
Document control is non-negotiable in regulated research.
- Centralized storage linked to individual subjects
- Role-based access for sensitive files
- &higlighttxt;Rapid retrieval&:higlighttxt; during audits and inspections
Essential documentation stays organized, protected, and always accessible.
One Platform for Laboratories and Clinical Research Teams
A unified solution for organizations operating across diagnostics and clinical research.
The result:
- &higlighttxt;Reduced system fragmentation&:higlighttxt;
- Improved data integrity
- Faster study execution
- Greater confidence during regulatory inspections
LIMSXL enables teams to focus on research outcomes not disconnected systems or manual tracking.
Benefits of implementing LIMSXL clinical trial management system
Centralized study and bioequivalence management.
Complete identifier traceability across subjects and visits.
Embedded ethics and regulatory compliance workflows.
Audit-ready documentation linked to each participant.
Configurable structure for multi-study and multi-sponsor research environments.
LIMSXL is not a generic tracker, it is a controlled clinical research execution system designed for regulated trials.
Case study: Clinical trial LIS implementation
Client Challenges
Our client Macleods Pharmaceuticals Limited faced major operational limitations with their existing clinical trial LIS software, particularly in two critical areas: &higlighttxt;1. Reporting Flexibility&:higlighttxt; and &higlighttxt;2. Compliance Accountability&:higlighttxt;.
The first challenge was related to test report formatting. Their legacy system relied on rigid Crystal Reports and hard-coded templates. Users were unable to design or modify report formats independently, this scenario created complete dependency on software developers for even small reporting adjustments.
The second major challenge was the absence of a robust audit trail, which is essential in regulated medical and clinical trial environments. Amendments, corrections, and data changes require clear accountability and documented justification. The old system failed to capture such modification data, creating compliance risk.
Our Solution
To address the reporting challenge, we delivered a robust and user-friendly report designing tool, enabling Macleods to create and customize test report formats as required. Users can independently configure report structure, select columns, adjust fonts, and insert predefined text without any developer dependency.
To strengthen compliance, we provided an in-built audit trail feature aligned with regulated clinical software requirements. The system includes a comprehensive “catch-all” logging table that records all amendments with proper abbreviations and valid traceability, ensuring accountability and inspection readiness.
Our domain expertise and compliance-ready architecture played a key role in securing the order.
Results & Key Learning
This implementation reinforced that clinical trial LIS software must be compliance-aligned by design to succeed in regulated research environments.
Scalable architecture, configurable reporting, and complete audit trails are not optional, they directly impact adoption, trust, and long-term usability.
A future-ready, inspection-ready system significantly improves the chances of successful deployment and repeat sales in clinical research organizations.
Frequently asked questions
Most CTMS software for clinical trials focuses on operational study tracking but sits outside lab systems. LIMSXL is built on a clinical LIMS, so trial operations and lab-controlled data live in one system—improving data integrity, traceability, and inspection readiness.
Yes. LIMSXL supports bioequivalence studies by managing BEQ numbers, linking them to study numbers, subjects, screening, enrollment, visits, and outcomes—ensuring complete traceability across the BE study lifecycle.
LIMSXL provides controlled Study No. and Subject No. assignment and tracking. These identifiers remain linked across visits, documents, results, and audit logs, supporting confidentiality and consistent participant history.
Yes. The system supports Screening IDs (including screen failures) and Enrollment IDs after consent—so you can track the participant journey cleanly from eligibility to study completion.
LIMSXL embeds compliance into daily workflows through role-based access, structured record retention, IEC approval tracking, and full audit trails. This supports inspection readiness and reduces compliance gaps common in spreadsheet-based tracking.
The system maintains a detailed audit trail for all amendments, including “who changed what, when, and why.” This is critical in regulated environments where accountability and documented reasons are required.
Yes. LIMSXL includes a user-friendly report designer where users can define formats, choose columns, set fonts, and add predefined text—without hardcoding or developer dependency. This is especially useful for clinical trial LIS reporting.