✔ 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 questionnaire.
✔ 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.
✔ 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.
✔ 24/7 Support.
✔ 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.