The method, the frameworks, and the record behind them.
Every service line, the delivery method, the four Centers of Excellence, and the documented record across every phase.
What rescue looks like when frameworks meet accountable delivery.
Results from the principal's documented record in prior roles, across 300+ protocols and 900 projects.
Every capability a sponsor needs, under one delivery architecture.
Many sponsors buy clinical operations in slices: monitoring only, RWE only, commercial only. Clinical TrialRx oversees the full clinical operations lifecycle, concept through post-market, so handoffs are governed and accountability stays in one place. We do not do the work. We make sure it is done right.
Category I · Trial Oversight and Rescue
We do not replace your CRO. We make sure every phase is planned right, governed tightly, and rescued fast when it slips.
Phase I First-in-Human
Oversight of first-in-human start-up, safety review, and site readiness.
Phase II Proof of Concept
Adaptive design and interim planning, delivered with your CRO and biostatistics partners.
Phase III Pivotal & Registrational
Governance and rescue for multi-country pivotal trials, including an $875M Phase III program: 10,101 patients randomized at 177 sites in 26 countries.
Phase IV Post-Market
Oversight of post-market commitments, safety surveillance, and REMS delivery.
RWE Observational & Registries
Design and vendor oversight for observational studies, PASS, and registries.
RWD Strategy & Data Lakes
Evidence strategy and data-partner oversight for submission-ready evidence packs.
Every RWE/RWD engagement is scoped to the use it must survive, because evidence built for the wrong buyer fails review at the right one. See the RWE Doctrine: one asset, every phase.
Category II · Quality, Oversight & Rescue
The governance layer: risk-based monitoring, auditing, and trial rescue across every phase, every design. Phase I through Phase IV, plus RWE/RWD registries. Rescue across Phase I to IV and RWE studies.
Risk-Based Monitoring
Risk-based monitoring strategy and oversight of your CRO's monitoring teams, with resources allocated by site risk and AI/ML-driven anomaly detection.
Quality & Auditing
GCP audits, vendor and CRO audits, regulatory inspection readiness, and deviation root-cause analysis.
Clinical Trial Rescue, Every Phase
The headline offering: rescue across Phase I to IV trials and RWE studies, from start-up stalls and enrollment shortfalls to data-integrity questions and evidence gaps. Every rescue runs on the same path.
Category III · Commercial & Win Solutions
Win more bids. Close bigger deals. Convert sponsor NOs into YES, using the same frameworks that drove a $1B / 5-year BD initiative.
Bid Defense Solutions
Cross-functional bid defense methodology developed and chaired at a Tier-1 global central laboratory firm. Win-strategy playbook per account, C-suite advocacy, competitive positioning.
Sales & BD Strategy
First Choice global sales strategy bridging BD, Operations, PM, and Commercialization. AOP alignment, pipeline architecture, top-25 pharma sponsor engagement.
Client Delight Activation
Voice of the Client (VOC) and Seven Pains diagnostic deployment, turn the seven reasons sponsors say NO into governed YES levers. Lift retention, expand wallet share, restore C-suite trust.
Two processes. One path. Bid commitments carried into delivery.
Our Business Acquisition Process (BAP) and Business Execution Process (BEP) run as paired systems: every commitment made in the bid phase is operationalized into execution without the handoff failures that commonly derail sponsor engagements.
BAP, Business Acquisition Process
Staged commercial pipeline from first interest through contract. Turns sales from art into a repeatable system.
BEP, Business Execution Process
Execution counterpart to BAP. Every sales commitment is operationalized, with a seamless handoff from won to delivered.
5-Stage-Gate Review System
Formal evaluation at every phase, risk surfaced early rather than at data lock. Matches management intensity to project complexity.
Seven capabilities, one accountable advisor.
Sponsors often buy these as slices: a monitoring firm, an RWE shop, a bid-defense consultant, an AI/ML vendor. Clinical TrialRx brings them together as one accountable advisory practice, with a documented delivery record at each level.
Every phase, plus RWE. 300+ protocols. 22+ therapeutic areas.
Clinical operations directed across every phase of the drug development lifecycle. The portfolio below reports aggregate totals by phase, the scale of trials the principal has been responsible for, not individual sponsor engagements.
Safety + PK/PD
Efficacy Signal
$875M Program
Long-Term Follow-Up
Every Phase
"Right the First Time, On-Time, On-Target."
What Clinical TrialRx delivers to every sponsor, so our clients Out-Pace in Their Space.
Right the First Time: the bid, the SOW, and the budget match the protocol before the first site opens.
The metrics behind the methodology.
Every framework on this site was forged in delivery: global trials, global commercial mandates, start-up advisory work, and 30+ international rescues. The portfolio below summarizes the principal's documented career record.
Portfolio Totals
The Trial Portfolio
Clinical trial accountability across every phase, every geography, and every regulatory pathway, from concept through submission through post-market surveillance.
22+ Therapeutic Areas
Multi-indication depth spanning oncology, cardiovascular, CNS / neurology, rare disease, endocrine, immunology, infectious disease, hematology, ophthalmology, and more across the drug development lifecycle.
Revenue Growth · Commercial Leadership
Commercial results from two separate senior roles at two different life sciences companies: a company-record $302M in revenue growth over 19 months from new and returning clients, and $107M in new business above plan from existing clients. Both were driven by the Client Delight model, alongside PM-COE buildout across three continents.
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