CONFORM logo

CONFORM

A platform enhancing clinical trial speed by integrating data management, quality assurance, and regulatory compliance in a unified system.

Solution by EDETEK
Visit website

Overview

CONFORM™ is a comprehensive platform designed to enhance the efficiency of clinical trial execution by integrating data management, quality assurance, and regulatory compliance. It offers a seamless solution for connecting, collecting, and consuming clinical trial data while adhering to industry standards.

Data Integration Gateway

This feature connects the CONFORM™ R&D Cloud with data from multiple providers, enabling secure ingestion and configurable processing flows. It supports modern and legacy data exchange formats, minimizing the burden on data providers and reducing costs and startup time.

Intelligent Metadata Hub

The hub provides metadata stewardship and study configuration using industry and therapeutic standards. It includes a graphical designer for data transformations and validation rules, reducing study initiation time and costs. It also supports centralized metadata management for various data collection systems.

Clinical Data Lake (CDL)

CDL stores all ingested and produced data, offering tools for data standardization, cleansing, and analysis. It supports various medical file types and enforces strict data handling rules, ensuring compliance and security.

Clinical Study Quality Management, Review and Analytics (IQ)

This module redefines data management with continuous data ingestion, cleaning, and role-based review. It enhances decision-making, patient safety monitoring, and study performance evaluation in a compliant environment.

Unified Data Repository (UDR)

UDR is a flexible repository supporting data cleaning, review, and analysis. It integrates with the Intelligent Metadata Hub, allowing for customizable data models and ensuring smooth interoperability across systems.

Clinical Data Management (CDM)

CDM streamlines data cleaning and quality assurance with operational dashboards and advanced discrepancy detection. It supports data visualization and validation rules, enhancing data accuracy and compliance.

Data Visualization & Analytics

This feature provides real-time analysis and graphical tools for data reviewers, offering customizable visualizations and patient profiles to facilitate data review and insights.

CHAT.IQ

CHAT.IQ is an AI-powered assistant that enables conversational data exploration and analysis, providing instant insights and enhancing collaboration within the CONFORM™ ecosystem.

Risk-Based Monitoring (RBM)

RBM enhances study oversight with automated notifications for high-risk indicators, enabling proactive risk management and regulatory compliance.

Centralized Study Issue Management System (CIM)

CIM offers integrated issue management, tracking all study-related issues and facilitating collaboration on resolutions, improving efficiency and compliance across clinical functions.

Meta

Category
Clinical Trial Management
Field(s)
Clinical & TrialsQuality & Compliance
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Tag(s)
Clinical Trials ManagementQuality & Compliance ManagementAI