Real-world evidence, built for the use it must survive.
Real-world evidence carried from feasibility through Phase IV and post-market, AI/ML trial analytics, and programs that turn data platforms into sponsor programs.
RWE is not a phase. It runs across the whole lifecycle.
Clinical TrialRx designs and oversees real-world evidence and real-world data programs across every stage of development, from the first feasibility question to post-market surveillance, so one consistent evidence base serves the protocol, the regulator, the payer, and the sponsor's commercial team.
Natural history and patient counts: is the study feasible?
Dose and safety context from real populations
Eligibility stress-tested; feasibility on real counts
Endpoints anchored; comparator context; amendment risk reduced
Label expansion; comparative effectiveness
Surveillance; payer dossiers; value-based contract evidence
- RWE study design across Phases I to IV: observational (NIS), PASS, registries, PRO, HEOR, and pragmatic Phase IV
- Systematic literature review and real-world data-lake strategy
- Submissible evidence packs for FDA, EMA, PMDA, TGA, and HSA
- RWE and RWD designs introduced to sponsors new to real-world evidence, implemented alongside their interventional programs
Scope an RWE program to the use it must survive: regulatory, safety, payer, or commercial.
Predictive Enrollment
ML models forecast site-level enrollment trajectories from screening, recruitment, and historical performance, flagging shortfalls before they reach the timeline.
Site Risk Scoring
Dynamic risk profiling across data quality, deviation rate, query velocity, and PI engagement, feeds the Risk-Based Monitoring queue automatically.
Monitoring Triage
Centralized monitoring algorithms surface anomalies in SDV, AE reporting, and protocol deviations, directing CRA effort to the sites that carry the most risk.
Signal Detection (PV)
Pharmacovigilance signal-detection models for safety and efficacy in post-market and RWE programs, surfacing trends early for safety review.
Data-Lake Generation
Real-world data-lake architecture ingesting claims, EHR, registry, and PRO data. Designed to produce FDA, EMA, and PMDA-submissible evidence packs.
Bid Scoring & Voice of the Client (VOC)
ML-driven bid-defense win-rate modeling and Voice-of-Client diagnostic, flagging where sponsor relationships are at risk, with intervention pathways.
Your platform holds the patients. Pharma buys the study.
EHR vendors, specialty-care software companies, and data platforms hold point-of-care data that sponsors need, but few have a team that speaks protocol, feasibility, and evidence. Clinical TrialRx is the translator between the platform and the sponsor.
A Study Execution Team, not a login
Cohort design, endpoints, historical controls, privacy and regulatory, and HEOR convened from vetted specialists for each program, from the first meeting to funding.
Pilots sponsors can say yes to
Protocol stress tests and site feasibility on real patient counts, priced as a first engagement that expands across the sponsor.
Provider networks as research venues
Point-of-care trial matching, e-consent inside the clinical workflow, and EHR-to-EDC capture turn provider organizations into trial sites.
The sponsor and CRO commercial motion
Pains-first sponsor outreach, CRO channel partnerships that put your data inside feasibility and bid defenses, and C-level positioning.
Every engagement is scoped within the privacy, consent, and data-rights terms your provider contracts already carry.
Turn originated data into sponsor programs, with a Study Execution Team (SET) convened from vetted specialists for each program.
Your trial is off-course.
We put it back on target.
Start with a no-obligation rescue assessment. We will diagnose where your program has drifted, map the VOC and Seven Pains failure points actively dragging it, and show you a governed path to recovery in 30 minutes.
Pittsboro, IN 46167