OneStudyTeam offers a cloud‑based collaboration platform that centralizes clinical trial workflows for sponsors, CROs, sites, patients, and regulators. The solution provides real‑time enrollment dashboards, integrated pre‑screening linked to EHRs, and bi‑directional APIs with CTMS and eTMF systems, while maintaining GCP, HIPAA, and 21 CFR Part 11 compliance. Predictive analytics and modular plug‑ins help accelerate recruitment and reduce manual data handling.
Funding
$220M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
ACFounders
Product
Problem
Clinical trial execution is hindered by fragmented workflows and limited real‑time visibility into patient enrollment, causing delays and increased operational costs for sponsors and research sites.
Solution
OneStudyTeam provides a cloud‑based collaboration platform that unifies the workflows of research sites, sponsors, patients, technology vendors, and regulatory bodies onto a single digital environment. The system streams enrollment metrics in real time, enabling sponsors to monitor recruitment progress and intervene proactively. Integrated pre‑screening tools allow sites to identify eligible participants efficiently, while automated data exchange reduces manual hand‑offs and documentation errors. Open APIs connect the platform with existing clinical trial management systems (CTMS), electronic health records (EHR), and regulatory reporting tools, creating a seamless end‑to‑end data flow. Role‑based access controls and audit trails ensure compliance with GCP, HIPAA, and 21 CFR Part 11 standards. By consolidating stakeholder interactions, the platform accelerates trial timelines and expands capacity for running multiple studies concurrently.
Target Audience
The primary customers are pharmaceutical sponsors and contract research organizations (CROs) that manage multi‑site trials, as well as research sites and investigators who need streamlined enrollment and reporting capabilities.
Features
- Real‑time enrollment dashboard with drill‑down metrics for sites and sponsors
- Integrated patient pre‑screening and eligibility workflow that syncs directly with site EHRs
- Bi‑directional APIs for CTMS, EHR, eTMF, and regulatory reporting systems (FHIR, CDISC)
- Role‑based permissions and immutable audit logs to satisfy GCP and 21 CFR Part 11 compliance
- Secure, HIPAA‑compliant data transmission and storage with end‑to‑end encryption
- Modular architecture allowing plug‑in of third‑party tools (e.g., eConsent, remote monitoring) without additional integration effort
- Predictive enrollment analytics powered by machine‑learning models that forecast recruitment milestones