A clinical trial program, built right the first time.
From market and referral-network assessment to the first sponsor studies, designed and governed by the principal who built four programs that all became global top-enrolling sites. Delivered remotely with remote teams, and on site when you want us there.
Assess
Market, therapeutic focus, and physician referral network
Design
Dedicated site or site management model, staffing, and budget
Ready
GCP, SOPs, patient recruitment, contracts, and liability coverage
Launch
Sponsor and CRO introductions, feasibility, and the first studies
Four Center of Excellence models. Deployable into any sponsor environment.
Every engagement applies four Center of Excellence models the principal built and led in prior global roles, built and led in prior global roles across pharma, biotech, device, and academic sponsors.
Outsourced delivery,
sponsor-retained control.
Governance architecture used for 30+ international rescues of Phase I–IV trials and RWE studies. The sponsor retains visibility, communication, and quality authority while Clinical TrialRx carries the governance load.
The "YES" system
, engineered, not aspirational.
Systematic approach combining Clinical-RWE Operations and Project Management across Phase I–IV, Late Phase, RWE, and Central Lab studies. Each of the 7 NOs in the Voice of the Client (VOC) framework becomes a YES lever: governed, measured, and owned.
Submission-grade real-world evidence, not post-hoc.
Standards, training, and delivery across 20 countries. Systematic literature review and real-world data-lake strategies producing FDA, EMA, PMDA, TGA, and HSA-submissible evidence packs. Observational, registry, PASS, PRO, HEOR, and pragmatic Phase IV designs.
Project management, operationalized for clinical.
Four PM Centers of Excellence built across the Americas, EU, and APAC. Standardized processes, training, and earned-value metrics lift delivery efficiency and client satisfaction across 20 countries. Integrates with AI/ML-driven trial analytics.
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