ELSY represents a technology solution that has the potential to revolutionise the way clinical trials are conducted. ELSY is designed to increase transparency and accountability in the trial process, from study design and protocol development to data collection and analysis. ELSY can potentially reduce study costs by eliminating manual processes, reducing errors and delays, and improving overall efficiency.
CTMS helps plan, track, and manage clinical trials. It supports study design, site selection, and sample collection, while tracking trial milestones like patient enrollment and regulatory submissions. The system ensures compliance with standards (e.g., ISO and CFR 21) and facilitates auditing.
CTMS tracks the collection, labeling, storage, and transportation of bio-samples. It maintains a chain of custody to ensure sample integrity and compliance with handling standards. The system links samples to patient data, enabling seamless integration with test results, including genomic and clinical analyses.
The system stores and manages patient demographics, medical histories, consent forms, and treatment data. It also supports patient recruitment and tracking throughout the trial, ensuring privacy and data security through role-based access.
CTMS handles clinical data collection, including previous events, lab results, and histo-pathology records. It ensures data accuracy through validation checks by Senior Clinicians/Reviewers.
CTMS stores and links genomic data (e.g., DNA sequences, biomarker profiles) with clinical trial outcomes, supporting precision diagnostic approaches. This enables the integration of sequencing data with patient records for comprehensive analyses.
The system generates reports on trial progress, patient enrollment necessary for regulatory compliance. It also supports customizable data visualizations, helping stakeholders make informed decisions and submit results to regulatory bodies.