EDC

Jeeva EDC is an electronic data capture system designed for clinical trials, offered as part of the Jeeva Trials decentralized clinical trial management platform. It targets sponsors, contract research organizations (CROs), clinical research coordinators, clinical research associates, monitors, and site staff who need a configurable, compliance-ready solution for collecting and managing clinical trial data. The system is described as lightweight, cost-effective, and rapidly configurable, and is trusted by over 13,000 users.

Jeeva EDC integrates with randomization and clinical trial management system (CTMS) functionality. It supports standard medical vocabularies including MedDRA and WHODrugDB, and complies with GCP, FDA, EMA, and ICH guidelines. The system generates detailed audit trails to maintain transparency and regulatory compliance throughout the trial process.

Core Capabilities

• Configure electronic case report forms (eCRFs) in under two weeks using a library of standardized eCRFs and study templates.
• Implement protocol amendments in minutes or hours at no additional cost.
• Monitor data quality and risks in real time.
• Automate forms and procedures with centralized scheduling of visits.
• Capture adverse events and symptoms using MedDRA data coding or controlled vocabularies.
• Capture concomitant medications (ConMeds) reported by patients or site staff using standardized terms from WHODrugDB.
• Apply data validation rules and checks at the point of entry to minimize human error and reduce post-collection data cleanup.
• Support flexible block or site randomization schemes with integrated CTMS.

Data Management Services

• End-to-end clinical data management (CDM) including data management plan development, CRF design tailored to protocol, and custom edit-check programming.
• Reconciliation of serious adverse events (SAE), pharmacokinetics (PK), and central laboratory data.
• Support for clean data lock and database closure for regulatory submissions.
• Outputs compliant with CDASH, SDTM, and ADaM data standards to facilitate biostatistics analysis and regulatory submissions.
• Risk-based data review strategy using central monitoring signals and automated KPI-driven query cycles to accelerate data cleaning.
• Proactive identification and resolution of data discrepancies.

Compliance and Audit Readiness

• Complete, traceable audit trails that log all data changes.
• Alignment with Trial Master File (TMF/eTMF) requirements to support regulatory audits and submissions.
• Compliance with FDA requirements and advanced data security features.
• Controlled change management process for mid-study EDC changes, including impact analysis, validation, and versioned updates with full traceability.

Collaboration and Real-Time Access

• Sponsors, CROs, and site staff can access data instantly as it is collected to perform clinical data management tasks.
• Real-time monitoring supports informed decision-making and swift responses to queries raised during the trial.
• Validated standardized data capture shared across all collaborating parties.
• Improved clinical trial data quality and simplified, automated clinical data management workflows.

Mid-Study Transitions and Study Rescue

• Supports mid-study transitions and rescue studies using structured migration playbooks, detailed data mapping, and dual-running approaches.
• Transfers ongoing studies to the Jeeva EDC platform while maintaining data continuity and mitigating transition risk.

Jeeva EDC is part of the Jeeva eClinical cloud, which is described as disease-agnostic, device-agnostic, and modular, designed to support decentralized or hybrid trial operations. The platform is positioned to reduce staffing needs for data management, shorten trial timelines, and lower overall clinical trial costs, particularly for organizations operating in emerging markets or conducting rare disease research.