R&D Cloud

EDETEK's R&D Cloud is a powerful, end-to-end clinical development ecosystem designed to accelerate the speed and quality of clinical trial execution. Built for pharmaceutical, biotech, and medical device companies, it brings together two integrated platforms — CONFORM™ and the eClinical Suite — to support the full clinical data continuum: from trial design and execution (Conduct), data integration (Connect), data aggregation (Collect), standardization and submission (Conform), through to data quality, monitoring, analytics, and visualization (Consume).

Powered by advanced AI/ML, the R&D Cloud is scalable, reliable, and flexible, offering a plug-and-play ecosystem with best-in-class capabilities, a near real-time clinical data pipeline, and unified data management. It is designed to integrate seamlessly with existing operational environments, supports therapeutic-area-specific accelerators for faster onboarding and submission, and maintains industry certifications with full regulatory compliance.

Key Benefits

• Tailored R&D cloud with best-in-class capabilities suited to clinical development needs
• Seamless implementation with existing operational environments
• Therapeutic-area-specific accelerators for faster study onboarding and regulatory submission
• Comprehensive set of end-to-end clinical trial capabilities
• Secure collaboration and workflow orchestration across internal and external stakeholders
• Industry certifications and compliance with applicable regulations

CONFORM™ Platform Capabilities

• Orchestration and Collaboration Manager: Orchestrates business and system events within and outside of CONFORM™ to enable a comprehensive, integrated, and compliant clinical ecosystem.
• SSO Manager: A multi-SSO capability that reduces friction, streamlines processes, increases security, and ensures uninterrupted access to critical systems, allowing collaborators to log in using their preferred authentication systems while meeting the highest security standards.
• Data Integration Gateway: Brings all study data together for further aggregation, processing, and analysis, featuring an extensive library of ready-to-use connectors that facilitate accelerated study startup.
• Intelligent Metadata Hub: Provides enterprise-grade data governance, curation, and validation through reusable libraries of data standards and business rules, ensuring accelerated trial setup, regulatory compliance, and reduced maintenance costs.
• Clinical Data Lake (CDL): A global, secure, and GxP-compliant information repository that stores all structured and unstructured clinical data and documents, maintaining a configurable clinical hierarchy and a content-searchable information store.
• Statistical Computing Environment (SCE): Enables development and execution of statistical programs with direct integration to the Clinical Data Lake and Study Analysis and Submission tools, supported by a comprehensive set of GxP controls.
• Study Analysis and Submission: Serves clinical programmers, biostatisticians, and submission teams with tools designed to minimize code writing and validation, promote reuse of standards, and improve the quality of regulatory submissions, freeing teams to focus on higher-value activities.
• Clinical Data Pipeline (CDP): A powerful, integrated data processing engine that captures and processes study data from any source, in any format or structure, transforming data streams into consumable data models based on industry, company, or therapeutic-area standards, and populating the Unified Data Repository (UDR) through advanced validation, transformation, and aggregation governed by study business rules.
• Clinical Study Quality Management, Review and Analytics (IQ): Redefines data management, medical review, and quality management through continuous data aggregation, advanced quality checks, scientific and operational data visualizations, safety and efficacy signal identification, site performance monitoring, and centralized issue management with configurable collaborative workflows and timely notifications.

eClinical Suite Capabilities

• Clinical Trial Management System (CTMS): Supports end-to-end study planning and operational management.
• Electronic Data Capture (EDC): Enables structured clinical data collection throughout the trial.
• eDiary / ePRO / eCOA: Facilitates electronic patient-reported and clinical outcome assessments.
• Risk Based Quality Management (RBQM): Supports proactive risk identification and quality oversight.
• Randomization and Trial Supply Management (RTSM): Manages randomization and investigational product supply across study sites.
• Additional components include an Interactive Web Response System (IWRS), Trial Supply Management (TSM), ePayments, and electronic Trial Master File (eTMF), providing a complete solution for study design, data collection, safety monitoring, and clinical documentation management.

EDETEK also offers complementary professional services including Biostatistics and Programming, Clinical Data Management, Study Development, Medical Writing, and eClinical Operations, providing end-to-end support from study design through regulatory submission for pharmaceutical, biotech, and medical device organizations.