When a trial is
off-course,
we put it back
on target.
Set it up. Keep it on course. Bring it back.Teams operating at full potential, at maximum speed, at highest efficiency.Clinical TrialRx works alongside your internal team and your vendors to keep every study heading Compass North, from first protocol to close-out.
What would 108 days back on your timeline be worth?Modeled per Phase III study: about $86M in sales reaching market sooner. See the model
Right the First Time, On-Time, On-Target: the methodology the principal installs so your teams, individually and collectively, Out-Pace in Their Space.
Three ways in. Wherever your study is today.
Your next protocol has not locked.
Science and operations at one table before the lock, the pre-award protocol and SOW gate, and your own team trained to hold the metrics after.
Right the First TimeYour study is running.
Keep it on course through close-out: Stage-Gate checks, monthly CRO metrics, and issues caught while there is still time to act.
CRO OversightYour trial is late, or about to be.
Diagnose where the program has drifted, which of the seven reasons sponsors say NO is dragging it, and the governed path back to On-Time, On-Target.
Clinical Trial and RWE RescueWhy sponsors say NO. How it becomes YES.
Seven pains sponsors report, ranked in the principal's Client Delight framework, in every phase of clinical trials, Phase I to IV, and in RWE/RWD studies. The best fix is prevention: set the study up right the first time, and the pains are designed out from the first day. When a study is already off track, every engagement finds the ones present and removes them, because a rescue that does not fix why trust broke will break again.
- 1Price / CostExcessive change orders52%
- 2StrategyScientific, operational, and organizational gaps49%
- 3RelationshipsPoor partnership42%
- 4RetentionNo personnel plan67%
- 5CommunicationNo critical communication plan42%
- 6AccountabilityNo clear owner71%
- 7Executive KnowledgeGaps at the executive leadership level52%
The data partner brings the asset. Clinical TrialRx makes sure the study delivers.
Delays show up in real-world data long before they show up on a timeline. Clinical TrialRx tests the protocol, the sites, and the enrollment plan against real patients first.
- Originated point-of-care data partners
- Data infrastructure and tokenization partners
- RWE analytics partners
- Protocol stress-testing and feasibility
- Site selection on real patient counts
- Governance of monitoring and data lock
- One accountable plan
- One bid, one delivery team
- Evidence built for the use it must survive
The enrollment play, every phase: start where the patients already are.
Real-world data shows where eligible patients are before a single site is chosen. Sites are selected on verified patient counts, not phantom feasibility numbers, so studies are positioned to start and finish on schedule.
Model: the start-up gain is a conservative estimate against median site activation of 4.4 to 8.1 months (WCG, 2023); amendments apply the principal's 45% fewer amendment cycles to about 90 days of schedule time an amended protocol loses (Tufts CSDD; the 260-day figure is the full approval window, not lost schedule time); database lock is the principal's documented average in prior roles. Value at about $800K per day in sales (Tufts CSDD, Day of Delay white paper, 2024). A model, not a guarantee.
Three rescue patterns. One result each.
Sponsor and asset names are withheld. Each pattern is drawn from the principal's documented record in prior roles, and every figure is reported as recorded.
The incumbent CRO was not performing.
Rescues brought back under Stage-Gate governance and CRO performance metrics.
Clinical operations · Portfolio15 in 18 moA division behind on its priority trials.
High-priority trials delivered, with a 30% operational efficiency gain.
Rescue trials · Multiple therapeutic areas45%Amendment after amendment.
Fewer amendment cycles, with evidence packs submissible to FDA, EMA, PMDA, TGA, and HSA.
Your CROs, working your way. Measured every month.
From the principal's documented record in prior roles.
Dashboard metrics reach the sponsor in real time at every Stage-Gate review.
Start-up metrics from the day of award: study team assembled, award briefing, expectations meeting, kickoff planned versus actual, schedule baselined, contract executed, and study plans signed off.
Prevention at every gate, from SOW to close-out.
Each gate catches errors while they still cost little to fix, so the data that reaches your final dossier is data you can use.
Protocol and SOW reviewed before the price is set
Team, scope, and schedule baselined
Sites, training, and risk log ready
Reviews at every enrollment milestone
Data cleaned and queries closed early
Audit-ready file and lessons learned
Every side of the table.
"Very simply, [the principal] was brilliant at damage control and developing solutions that could fix the worst of projects."
Senior Clinical Project Manager who reported to the principal, top-five global CRO
"Not only did [the principal] and this model help me to recover a failing project and move the project's [risk status] away from red, but also, I applied his model to my other projects and those projects have stayed green for over 16 months!!"
Senior Clinical Project Manager who reported to the principal, top-five global CRO
"[The principal] made an immediate impact on the business and was able to quickly understand the complexities of our organization, mobilize the team, and deliver results."
Project Management Supervisor who reported to the principal, leading global central lab
Your next database lock, 38 days sooner.
The principal's documented average across prior roles. What would that mean for your next readout? Start with a no-obligation assessment, whether your study is starting, under way, or off course.
Pittsboro, IN 46167