Rick Greenfield
Founder & Chief Strategy Officer
RealTime eClinical Solutions
RealTime offers a cloud‑native eClinical SaaS that combines a Clinical Trial Management System with electronic regulatory, source, and consent modules, plus participant engagement and digital payment tools. The platform provides real‑time data synchronization, API‑first integration with EDC, ERP and analytics systems, and built‑in analytics dashboards, while meeting 21 CFR Part 11 and GDPR compliance for sites, CROs and sponsors.
Updated 6 months ago
Funding
Funding rounds are not available yet.
Founders
Product
Problem
Clinical trial teams often rely on disparate systems for study management, regulatory documentation, source data capture, and participant engagement, leading to fragmented workflows, duplicate data entry, and delayed decision‑making.
Solution
RealTime delivers an enterprise‑grade eClinical platform that unifies the entire trial lifecycle—from study start‑up and site operations to data capture, compliance, and participant payments—within a single, cloud‑native suite. The solution integrates a full‑featured Clinical Trial Management System (CTMS) with electronic regulatory (eReg/eISF), electronic source (eSource), eConsent, and engagement tools such as SMS reminders and digital payment processing. Real‑time data synchronization and a robust API layer eliminate manual transfers and enable seamless connectivity to external EDC, ERP, or analytics systems. Built‑in analytics dashboards and a mobile app give sites, sponsors, and CROs instant visibility into key performance indicators, while role‑based access controls and 21 CFR Part 11 compliance ensure data security and audit readiness.
Target Audience
Primary customers are clinical research sites, site networks, academic medical centers, contract research organizations, and pharmaceutical sponsors that need an integrated, compliant platform to manage both research and business operations of their trials.
Features
- Modular SaaS architecture that bundles CTMS, eReg/eISF, eSource, eConsent, payment (GlobalPay/SitePay), and SMS/Text messaging into a single tenant instance.
- API‑first integration framework with RESTful endpoints and FHIR‑compatible adapters for bi‑directional data flow to EDC, ERP, and third‑party analytics platforms.
- Automated source‑to‑EDC capture (EDC Connect) that removes duplicate manual entry and enforces data integrity at the point of collection.
- Participant portal (MyStudyManager) and mobile app delivering consent signing, schedule reminders, and secure digital payments on iOS/Android devices.
- Real‑time analytics engine with configurable KPI dashboards, Devana metrics, and exportable reports for site performance and financial tracking.
- Enterprise‑grade security: role‑based access control, audit trails, encryption in transit and at rest, and compliance with 21 CFR Part 11 and GDPR.
- Configurable workflow automation for study start‑up, budget approval, milestone tracking, and regulatory document versioning.