eClinical Suite

Clinical trial management, electronic data capture, patient-reported outcomes, risk-based quality management, and randomization & supply management for end-to-end study execution.

Solution by EDETEK

Overview

EDETEK's eClinical Suite is a fully integrated, end-to-end clinical trial management and execution platform designed for pharmaceutical, biotech, and medical device companies. It brings together five tightly coupled components — CTMS, EDC, eDiary/ePRO/eCOA, RBQM, and RTSM — into a unified solution that covers every stage of study planning, execution, and oversight. The suite operates as part of EDETEK's broader R&D Cloud ecosystem and integrates seamlessly with the CONFORM™ platform modules.

The eClinical Suite is purpose-built to streamline clinical operations, improve data quality, enhance patient engagement, and ensure regulatory compliance across global trials of all phases and complexities, including large late-stage Phase 3 pivotal studies.

Clinical Trial Management System (CTMS)

Advanced, integrated solution for managing the operational aspects of clinical trials
Optimizes and streamlines clinical trial operations while maintaining compliance with industry standards
Designed to integrate seamlessly with other CONFORM™ modules for a fully unified platform
Manages everything from data capture to patient engagement, compliance, and risk within a single environment

Electronic Data Capture (EDC)

Feature-rich data collection tool fully integrated with the CONFORM™ Suite for seamless trial execution
Comprehensive CRF design and library support
Local lab and external data management
Extensive reporting for full study oversight
Advanced SAE reporting and medical coding
Alerts and notifications for proactive trial management
Full life-cycle management
Proven in over 700 clinical studies, including large, late-stage Phase 3 pivotal global trials

eDiary / ePRO / eCOA

Comprehensive tool for managing patient-reported outcomes and clinical assessments electronically
Enables real-time capture of patient-reported data and clinician assessments
Open architecture for easy integration with other systems and CONFORM™ modules
Robust eCOA capabilities supporting a wide range of assessment types
Enhanced patient engagement features to improve compliance and data quality
Real-time data ingestion and synchronization
High-performance, intuitive interface for both patients and clinical staff
Comprehensive reporting and analytics

Next-Generation AI-Driven Risk-Based Quality Management (RBQM)

Leverages AI/ML, advanced analytics, and an integrated data pipeline for next-generation trial quality management
Provides a comprehensive, real-time approach to managing trial quality and monitoring risks
Covers the full workflow from data integration through to issue resolution
Delivers superior trial oversight through seamless integration with the broader EDETEK technology platform
Draws on EDETEK's deep domain expertise in clinical trial quality management

Randomization and Trial Supply Management (RTSM)

Manages patient assignments, treatment allocation, and investigational product management from a single intuitive platform
Support for complex and adaptive study designs
Efficient randomization and supply management workflows
Built-in metrics and comprehensive reporting
Support for risk-based monitoring and remote monitoring
Capabilities to accelerate study start-up

The eClinical Suite is part of EDETEK's R&D Cloud, which also includes the CONFORM™ platform offering capabilities such as a Clinical Data Lake, Statistical Computing Environment, and Study Analysis and Submission tools. EDETEK complements the eClinical Suite with professional services including Clinical Data Management, Biostatistics and Programming, eClinical Operations, Study Development, and Medical Writing, providing a comprehensive offering for sponsors seeking end-to-end clinical trial support.