Octalsoft Unified eClinical Suite (EDC, IWRS, CTMS)

Octalsoft Solutions Private Limited is an eClinical software company established in 2007, with offices in Ahmedabad, India, and Herndon, Virginia, USA, and a team of 60+ experts. It serves pharmaceutical sponsors, CROs, sites and research organisations that need validated software to run clinical trials without stitching together separate point solutions.

The unified platform covers 18 modules, including EDC, IWRS/RTSM for randomisation and drug supply forecasting, CTMS, clinical trial supply management, ePRO, eConsent, eTMF, remote source data verification, imaging, RBQM, QMS, LIMS, biorepository management and eClinical analytics. AI/ML features include predictive risk analytics, automated data cleaning and validation, and decision support. The company reports 30,000+ platform users, 8,000+ clinical sites and clients in more than 22 countries.

• EDC: configurable eCRFs with real-time edit checks for faster database lock.
• IWRS/RTSM and CTSM: randomisation, drug supply forecasting and site inventory.
• CTMS: cloud-based trial tracking and monitoring across sites.
• ePRO and eConsent: patient-reported outcomes and electronic informed consent.
• eTMF and rSDV: trial master file workflows and remote source data verification.
• AI/ML analytics: predictive risk analytics, automated data cleaning and RBQM dashboards.

Vietnamese CROs can run EDC, randomisation and trial management for sponsor studies on one validated platform. Hospital clinical research centres can use CTMS and eTMF to manage multiple investigator-initiated and sponsored trials. Domestic pharmaceutical companies can manage bioequivalence studies and trial supplies.

One connected platform avoids integration work between separate EDC, randomisation and trial management vendors. Remote source data verification reduces on-site monitoring costs. Built-in RBQM and risk-based data management support ICH-aligned oversight. As an India-based vendor with a US office, it offers an Asia-time-zone alternative to large Western eClinical suppliers.

Asia is gaining share of global clinical trials, and regional CROs and sponsors want eClinical tools priced for mid-sized studies. Vietnam's push to expand clinical research and bioequivalence capacity increases demand for affordable, Part 11-aligned EDC, randomisation and trial management in one system.

Established in 2007; registered office in Ahmedabad, Gujarat, India, with a US office in Herndon, Virginia; 60+ staff. Reports 30,000+ users, 1.5 million+ lives touched and 25+ therapeutic areas. Silver Sponsor at SCDM 2025 India in Hyderabad.