Clinion AI-powered eClinical Platform (EDC, CTMS, RTSM)

Clinion AI Technologies is an eClinical software company led by founder and CEO Manuj Vangipurapu, with offices in the USA, India and the UK. It helps pharmaceutical, biotech, medical device sponsors and CROs run trials with less manual data work, and reports more than 655 trials, 100+ customers and 300,000 subjects from phase I to IV, including a Covaxin phase I/II deployment in 2021.

The unified platform covers AI-driven electronic data capture with CDASH mapping, remote source data verification and AI medical coding, plus CTMS, RTSM, ePRO, eConsent, eSource, eTMF and an image repository that redacts patient identifiers with AI. Generative and agentic AI tools draft ICH M11-aligned protocols, automate parts of clinical study reports and answer natural-language questions about protocols and live study data inside the EDC.

• AI-driven EDC: study setup, CDASH mapping, data review and AI medical coding.
• CTMS: milestones, site monitoring and budgets integrated with EDC and RTSM.
• RTSM: randomisation and trial supply management run through the EDC.
• ePRO and eConsent: participant data capture standalone or linked to EDC.
• eProtocol and CSR automation: drafts ICH M11-aligned protocols and parts of study reports.
• Agentic assistant: natural-language queries on protocol knowledge and live study data.

Vietnamese CROs can run EDC, CTMS and RTSM on one platform for sponsor studies. Vaccine and biosimilar developers can manage large phase III trials with remote data verification. Hospital research units can use eConsent and ePRO to follow participants in investigator-initiated studies.

The company claims its platform can cut trial costs by 35% and speed time to market by 30%. One unified system replaces separate EDC, CTMS, RTSM and ePRO vendors. AI medical coding and remote source data verification reduce manual data management work. It has supported large remote trials, including a 14,000-subject study in India.

Sponsors are adopting generative and agentic AI to speed protocol writing, data cleaning and study reporting. Cost pressure favours unified eClinical suites over multiple point tools, especially for mid-sized biotechs and CROs in Asia. Vietnam's plan to expand clinical trial capacity will need affordable EDC and CTMS tools for local CROs and hospital sites.

Legal entity Clinion AI Technologies Pvt Ltd, led by founder and CEO Manuj Vangipurapu; offices in the USA, India and the UK. Reports 655+ trials including 150 FDA and 100 EMA studies. Finalist at the Citeline Awards 2025, ACDM data management award (2025) and SCDM 2025 finalist. Recognised by Frost & Sullivan.