Clinical trial and RWE programs, set up right, kept on course, or rescued back on target.
For sponsors, CROs, emerging biotech leaders, medical device companies, hospitals, and research sites.Independent set-up, oversight, and recovery that holds every study to the plan that was bought, whether you are the sponsor, the delivery partner, or the site.
Why sponsors say NO: $1.1B+ in bid opportunity lost at one CROWhat 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 and which of the seven reasons sponsors say NO is dragging it, then chart the governed path back to On-Time, On-Target.
Clinical Trial and RWE RescueWhy sponsors say NO. How it becomes YES.
Seven Sponsor Pains, ranked in the principal's Client Delight framework, appear 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 ordersMeasured: adherence to agreed budget52%
- 2StrategyScientific, operational, and organizational gapsMeasured: strategic expertise and advice49%
- 3RelationshipsPoor partnershipMeasured: responsiveness to issues42%
- 4RetentionNo personnel planMeasured: staff turnover on projects67%
- 5CommunicationNo critical communication planMeasured: communicationLowest score in the report: provider proactivity, 71% not satisfied42%
- 6AccountabilityNo clear ownerMeasured: quality oversight and governance53%
- 7Executive KnowledgeGaps at the executive leadership levelMeasured: attention from senior staff52%
Teams operating at full potential, at maximum speed, at highest efficiency.
$1.1B+ is the principal's win-loss analysis in a prior role. It counts the first award only. It excludes the expansion, repeat, and reference business each lost bid defense closed the door on.
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 months (independent sites) to 8.1 months (academic centers and hospitals), WCG, 2023; the amendment gain applies the principal's 45% reduction in amendment cycles to the roughly 90 days of schedule time an amended protocol loses (Tufts CSDD; the roughly 260 days an amendment takes from need to final approval is the full approval window, not lost schedule time); data 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, 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.
Dashboard metrics reach the sponsor every week, and are reviewed in full at every Stage-Gate.
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 data 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