A complete Document Management System.
Regulated by 21 CFR Part 11 and Controlled.
Developed based on DIA TMF Reference Model.
QC System Logics.
CRA Verification Process.
Real-time Logs and Forms.
Integrated SUSARs system.
Tracking and Reports.
Smart Notifications and Alerts.
System Migration Assistance.
A patient friendly, study-specific application.
Electronic drug diary.
Direct reporting of symptoms / AEs from the patient.
AE and SAE management for real-time assessment by nurses and doctors.
Electronic health questionaires
Patient reminders and alerts.
Integration to eCRFs for easy transfer of data.
Compliant with 21 CRF Part 11, FDA and ICH-GCP.
Available in required languages.
In-built document sharing for confidentiality agreements and synopsis.
Pre-prepared questions to choose from.
Ability to add more study-specific questions in just few clicks.
Document upload functionality – For those initial essential documents.
Automated email reminder.
Real-time progress overview.
Designed to increase the interactivity between sites and clients.
Electronic Learning Management system for sites to complete study specific trainings and perform re-training when assigned.
Study specific discussions and sharing of best practices.
Access to study specific tools like trackers, calculators etc. to ease patient management.
A Robust Clinical Trial Management System build to assist the project team with the day-to-day activities.
In-build visit report management system.
Automated follow-up letter generation.
Site visit and patient visit management.
Protocol Deviation Management.
Source Data verification Management.