Elias Tharakan

About Elias Tharakan

Is your clinical trial technology stack slowing you down? Are you evaluating AI adoption in an FDA-regulated environment?I help biotechs and CROs move faster with less risk—accelerating timelines through smart technology and process optimization.I’ve spent over 15 years building the technology infrastructure that runs global clinical trials. As the architect of the life sciences industry’s first unified eClinical SaaS platform (DSG), I led a system that powered trials and supported dozens of drug approvals across diverse therapeutic areas, including oncology and major blockbusters. This journey culminated in a successful acquisition by Signant Health in 2023—a validation of architecture built for scale and successful exits.Today, I lead a unique ecosystem designed to close the gap between brilliant science and clinical execution- Through CliniDash, I build \"Compliant AI\" frameworks and AI-native platforms and tools for next-generation, patient-centric trials- Through AyurDatta Solutions, I provide a unique market offering: Integrated Clinical & Technical Leadership. Alongside world-renowned oncologist Dr. Ashok Srivastava (Fractional CMO), we ensure your protocol design, data models, and technology stack are aligned before a single site is activated.• One point of accountability: We manage the clinical execution and the technology outcome simultaneously.• Investor-Ready: We build high-fidelity data rooms and operational dashboards that demonstrate regulatory maturity to Series B/C investors from day one.• FAST Methodology: Driving acceleration by combining technology leverage and process optimizations, delivering regulatory-compliant trials.• Compliant AI: Implement Agentic AI with \"Expert-in-the-Loop\" integrity for GxP and FDA Part 11 environments.I serve as a Fractional CTO / Strategic Technology Advisor for Series A–C biotechs, mid-size CROs, and clinical technology companies:• Strategy & Architecture: Unified stack design (EDC, CTMS, RTSM, eCOA, Safety, DCT).• Vendor Selection & Audit: Independent, vendor-neutral evaluation of your current stack or CRO deliverables.• Technical Diligence: Preparation for M&A or high-stakes fundraising rounds.If you need executive-level technology leadership to de-risk your clinical programs without the overhead of a full-time hire or need to build compliant platforms or solutions, let’s talk.

Experience

1. Co Founder & CEO

   Clinidash

   Aug 2024 — Present · PA, US

   Architecting CRF Part 11, HIPAA and GDPR-compliant AI frameworks that prioritize data privacy, auditability, and algorithmic transparency to meet the rigorous regulatory standards of global healthcare.• & : Engineering tailored developer tools and middleware designed to streamline the integration of Agentic AI and LLMs into legacy clinical systems, ensuring secure data orchestration and high-fidelity model outputs.• : Developing AI-first eClinical infrastructure and data fabric for applying agentic AI to real-time data capture, anomaly detection, and query automation — targeting the workflow inefficiencies that cost sponsors and CROs months per trial.• : Building proprietary models for clinical data quality, CDISC-compliant data mapping, and proactive risk-based monitoring, grounded in 20+ years of operational knowledge of where trials fail.• : Actively engaging pharma, CRO, and strategic partners to validate product-market fit and shape commercialization strategy.

Education

• Cochin University of Science and Technology

  Bachelor of Technology (B.Tech.), Computer Engineering

• Wharton Executive Education

  Wharton CTO Program

Skills

• Asp.net Ajax
• Product Management
• Pl/Sql
• Software Development Life Cycle (Sdlc)
• Business Process
• Jquery
• Xml
• Web Applications
• Unix
• Databases
• Big Data
• Microsoft Sql Server
• Agile Methodologies
• Product Development
• Web Development
• Wcf
• Perl
• Business Analysis
• Oracle
• Requirements Analysis
• Design Patterns
• Javascript
• Business Strategy
• Sdlc
• Sql
• Asp.net
• Web Services
• Software Engineering
• Vb.net
• Software Development
• C#
• .net
• Oop
• Java
• Ajax
• Software Project Management
• Asp.net Mvc
• Product Marketing
• Soa