Working with top global pharmaceutical sponsors, company doubles down on agentic AI and RBQM investments to bend the clinical development efficiency curve

BOSTON: eClinical Solutions LLC, a global provider of digital clinical software and services, today announced 2025 milestones along with new 2026 innovation to support the end-to-end clinical research lifecycle, bringing breakthrough therapies to patients faster. Last year the company added over 20 net new customers to its portfolio of biopharma and CRO clients, which now includes 18 of the top 50 pharmaceutical companies in the world, supporting clinical trial leaders with an AI-first, risk-based approach.

Notably, eClinical Solutions focused on evolving elluminate as a clinical data intelligence platform to improve trial efficiency, debuting elluminate agents. The agents are fueled by data products with shared context and workflows with agentic, assistive, and task-oriented AI, and a data foundation with grounding guardrails and policies. Additionally, the company launched a digitized Integrated Data Review Plan (IDRP), positioning eClinical Solutions as the first company to centralize digital data review within a single platform, and announced an industry collaboration with ZS, pairing eClinical Solutions’ elluminate RBQM (risk-based quality management) technology with ZS’ RBQM consulting and custom-built solution expertise to create a unified integrated quality risk management (IQRM) experience for sponsors.

Other key company highlights from 2025 included industry recognition in Everest Group's Tech Provider Spotlight: Risk-Based Quality Management (RBQM) report, highlighting eClinical Solutions’ elluminate RBQM capabilities. eClinical Solutions also won the 2025 Top Workplace USA Award: Remote Work and the 2025 Top Workplaces Culture Excellence Award: Work-Life Flexibility, for the fourth consecutive year. Finally, the Society for Clinical Data Management (SCDM) awarded eClinical Solutions with the SCDM Innovation Award for Advancements in Health Insight Generation and elected Dawn Kaminski, Vice President of Business Development Operations at eClinical Solutions as Executive Secretary of the SCDM Board for 2026.

Building on 2025 momentum, the company has unveiled new updates to the elluminate platform this year aimed at supporting sponsors’ objectives - from ensuring ease of compliance with the revised ICH E6 R(3) guidelines to expanding agentic AI efficiencies:

• Agentic data review automation: The Explain Agent in Data Central uses clinical data and protocol-aware intelligence to interpret charts in real time, highlight meaningful patterns, and recommend next steps, eliminating hours of manual navigation by delivering instant, explainable insights where reviewers work.
• End-to-end RBQM traceability: RACT integration into review objectives plus RBQM Snapshots to preserve evidence over time, improve audit readiness, and strengthen follow-up execution.
• Faster, more consistent RBQM setup: Study-level RBQM configuration with linkage to global KRIs/QTLs and the ability to auto-pull KRIs/QTLs from RACT, reducing manual effort and accelerating study startup.
• Guided centralized monitoring experience: In-context KRI/QTL/risk signal review - thresholds, recommendations, related observations - directly from the RBQM Overview to drive faster, more consistent decisions.
• Agentic SDTM mapping automation from spec to executable code: Automated and agentic-AI-powered specification generation, plus transparent code generation - Python/R/SAS - with traceability from spec through execution logs to accelerate submission-ready datasets.

“Insight from clients and partners at ENGAGE 2025 and the data from our 2025 Industry Outlook Survey reaffirmed our conviction of creating a strong data intelligence foundation through the elluminate platform that elicits scalable innovation, from embedding intelligence to risk-based approaches,” said Raj Indupuri, CEO and co-founder of eClinical Solutions. “As we look at our next phase of growth, we’re hyper-focused on driving return on investment for our clients and leaning into agentic AI in 2026, for the next era of clinical trial automation.”

About eClinical Solutions LLC
eClinical Solutions’ industry-leading clinical data intelligence platform, elluminate®, and biometrics services experts help biopharma researchers at large, mid-size, and emerging life sciences organizations develop tomorrow’s breakthroughs with today’s resources. eClinical is a privately-held, purpose-driven company with a global workforce and winner of the 2025 Top Workplace USA Award: Remote Work, the 2025 Top Workplaces Culture Excellence Award: Work-Life Flexibility, and Great Place To Work® India Certification™. Learn more at www.eclinicalsol.com and follow eClinical Solutions on LinkedIn.

Fonte: Business Wire