Tailored “R&D cloud” with best-in-class capabilities
Seamless implementation with existing operational environments
Therapeutic-area specific accelerators for faster onboarding and submission
Comprehensive set of end-to-end capabilities
Secure collaboration and workflow orchestration across internal and external stakeholders
Industry certifications and compliant with regulations
Orchestrate business and systems events within and outside of CONFORM™ to enable a comprehensive, integrated, and compliant clinical ecosystem
Managing authentication shouldn’t slow down innovation or increase risks. Our multi-SSO capability reduces friction, enabling organizations to streamline processes, increase security, and ensure uninterrupted access to critical systems. This technology allows collaborators to log in using their preferred systems while meeting the highest security standards.
This key capability in CONFORM™ that brings all study data for further aggregation, processing and analysis. CONFORM™ has an extensive library of ready to use connectors that facilitate accelerated study startup.
CONFORM™’s metadata management consists of the tools that provide enterprise-grade data governance, curation, and validation. Reusable libraries of data standards and business rules ensure accelerated trial setup, compliance with regulations and reduced cost of maintenance.
CDL is a global, secure and GxP compliant information repository that stores all structured and unstructured clinical data and documents. It maintains a configurable clinical hierarchy and an information store searchable by content, attributes, metadata and tags.
Statistical Computing is a capability that enables development and execution of statistical programs while offering direct integration with CONFORM™’s Clinical Data Lake (CDL) and all the Study and Analysis and Submission tools with comprehensive set of GxP controls
CONFORM™ serves the needs of clinical programmers, biostatisticians and submission teams with a set of products designed to minimize code writing and validation, promote re-use of standards and ultimately improve the quality of regulatory submissions. It allows team members to focus on higher value activities such as data and document review, and interpretation of results.
The Clinical Data Pipeline (CDP) is a powerful, integrated data processing engine designed to capture and process study data from any study data source, in any format or structure, transforming the data streams into consumable data models based on industry, company or TA standards, and populating the Unified Data Repository (UDR). Through advanced data validation, transformation, and aggregation processes governed by study business rules, CDP ensures data timeliness, consistency and reliability.
The Clinical Study Quality Management, Review and Analytics (IQ) redefines data management, medical review and quality management with an integrated platform that supports continuous data aggregation, data cleaning with advanced quality checks, scientific and operational data visualizations and monitoring and collaborative workflows.
The system continuously monitors study data, identifies and reports safety and efficacy signals and evaluates study and sites performance and compliance with the protocol. The Platform centralizes issue management automatically recording and managing issues and protocol deviations from internal and external clinical systems. Configurable workflows and timely notifications enable collaborative, role-driven resolutions and corrective actions.
The eClinical Suite of applications is a comprehensive universal portal consisting of:
Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Interactive Web Response System (IWRS), Trial Supply Management (TSM), ePayments, and electronic Trial Master File (eTMF).
eClinical provides a complete solution for study design and conduct, data collection, safety monitoring, clinical data and documentation management, and much more!