AIIA Clinical Trials Dashboard - a real-time, cloud-based, GCP-compliant Clinical Trial Management System (CTMS) for Ayurveda research, with CDISC/FHIR-interoperable data, role-based KPIs, and integrated ethics, regulatory (CTRI / NDCT Rules 2019) and pharmacovigilance tracking.

Background

The All India Institute of Ayurveda (AIIA) conducts and coordinates a growing portfolio of clinical research in Ayurveda - interventional and observational studies, multi-centre trials - and, as the host of the National Pharmacovigilance Coordination Centre (NPvCC) for ASU&H drugs, it also anchors nationwide safety surveillance. This activity is governed by a demanding compliance framework: mandatory prospective registration in the Clinical Trials Registry – India (CTRI); the Good Clinical Practice guidelines for ASU medicine (GCP-ASU) and the ICMR National Ethical Guidelines; the New Drugs and Clinical Trials Rules, 2019 where applicable; Institutional Ethics Committee oversight; and timely Adverse-Event / Serious-Adverse-Event reporting. Yet study status, recruitment, milestones, data quality and safety signals are typically tracked across spreadsheets and disconnected tools, with no single, real-time, auditable view. The result is delayed decisions, missed reporting timelines and avoidable compliance risk - precisely as Ayurveda research scales and seeks global scientific credibility.

Description

The platform is a real-time, cloud-based Clinical Trial Management System (CTMS) and monitoring dashboard that gives AIIA a single, role-based, auditable view of its entire clinical-research portfolio.It tracks each study across its lifecycle - protocol and Institutional Ethics Committee approval, CTRI registration, site activation, screening, enrolment and randomization against target, visit and protocol-deviation compliance, data-query and data-quality status, study milestones and timelines, and close-out - surfaced as real-time Key Performance Indicators (KPIs) with configurable alerts (for example, enrolment lag, an ethics approval or CTRI update due, or an overdue monitoring visit).Because AIIA hosts the NPvCC, the dashboard integrates pharmacovigilance: it captures and routes Adverse Drug Reaction / Adverse-Event / Serious-Adverse-Event reports against regulatory reporting timelines, coded to standard dictionaries (MedDRA, WHODrug), and feeds aggregate safety signals to the Data Safety Monitoring Board and institutional leadership.Data must follow recognised clinical-research standards - CDISC (CDASH for data collection, SDTM for tabulation, ADaM for analysis) and HL7 FHIR R4 for interoperability with Electronic Data Capture (EDC), the hospital information system and Ayushman Bharat Digital Mission (ABDM) building blocks - with full ALCOA+ data integrity and an immutable, time-stamped audit trail. Access is strictly role-based (Principal Investigator, study coordinator, monitor, Ethics Committee, pharmacovigilance, administration, and read-only regulator views).The platform must comply with GCP-ASU, the ICMR ethical guidelines, the NDCT Rules 2019 and CTRI requirements, and with the Digital Personal Data Protection Act, 2023 and its 2025 Rules - including informed-consent management, data minimisation, encryption, and hosting on compliant, data-resident cloud infrastructure secured to ISO/IEC 27001 and CERT-In norms, since clinical-trial data is sensitive personal data.

Expected solution

A deployable, cloud-based CTMS-and-analytics dashboard providing: a real-time portfolio view with per-study drill-down; configurable KPIs and alerting; strictly role-based access and an immutable, ALCOA+-compliant audit trail; CDISC-aligned data models and HL7 FHIR R4 / ABDM interoperability with EDC and the hospital information system; an integrated pharmacovigilance module (AE/SAE capture, MedDRA/WHO Drug coding, regulatory-timeline tracking) reflecting AIIA’s NPvCC role; CTRI and ethics/regulatory milestone tracking; informed-consent and privacy controls aligned to the DPDP regime; electronic-signature and data-integrity controls consistent with GCP; and the ability to export submission-ready datasets (SDTM / ADaM, Define-XML). It should present tailored dashboards for Investigators, the Ethics Committee, pharmacovigilance and institutional leadership, and be hosted on secure, data-resident cloud infrastructure (ISO/IEC 27001, CERT-In). The build can be staged - a core study-tracking and KPI MVP first, then EDC/FHIR integration and the pharmacovigilance module, then full CDISC submission export and advanced analytics. The system should be evaluable on data accuracy and integrity, timeliness of safety and regulatory reporting, interoperability conformance, and access-control and audit completeness.