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.
Archiving.
24/7 Support.
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.
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.
Appointment management.
Integration to eCRFs for easy transfer of data.
Compliant with 21 CRF Part 11, FDA and ICH-GCP.
Available in required languages.
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.