Why sponsors say NO: $1.18B loss at one CRO

When a trial is
off-course,
we put it back
on target.

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.

Start a Rescue Assessment
Why sponsors say NO: $1.18B loss at one CRO
DATA-LOCKS: 38 DAYS AHEAD OF SCHEDULE 97% OF STUDIES ON BUDGET SOW / UAT ERRORS REDUCED: 98% SPONSOR COMPLAINTS REDUCED: 94% RIGHT-THE-FIRST-TIME ON-TIME ON-TARGET DRIFTING TRIAL RESCUE PATH OFF-COURSE
Who we help · pick your seat
SponsorsCRO oversightYour CROs, working your way CROs and VendorsRFP, bid defense, recoveryYour rescue partner, not your replacement Biotech and FSPBuild it right, no payrollFrom first trial to full FSP team Health-Tech and DataPlatform to pharmaYour data, turned into sponsor programs Sites and CROsAudit readinessReady before the inspector arrives Hospitals and Medical GroupsClinical trial program buildResearch revenue, built right
The Client Delight Framework

Why sponsors say NO. How it becomes YES.

Seven pains, ranked by sponsors, in every phase of clinical trials, Phase I to IV, and in RWE/RWD studies. Every engagement finds the ones present and removes them, because a rescue that does not fix why trust broke will break again.

Chess pieces set for play down a boardroom table, the chairs and the head seat in view, representing strategy at the executive level
The NO · Seven pains, rankedSatisfied today
  1. 1Price / CostExcessive change orders48%
  2. 2StrategyScientific, operational, and organizational gaps51%
  3. 3RelationshipsPoor partnership58%
  4. 4RetentionNo personnel plan33%
  5. 5CommunicationNo critical communication plan58%
  6. 6AccountabilityNo clear owner29%
  7. 7Executive KnowledgeGaps at the executive leadership level48%
The YES
Six disciplines. One promise kept.
Kickoff andsite activationSOW, UAT,and EDCdeliverySitemanagementData lock andaudit readinessBudgetmanagementRisk analysisand budgetreview Trust CONTROLVISIBILITYCOMMUNICATIONQUALITY
TrustControl · Visibility · Communication · Quality
Kickoff and site activationSOW, UAT, and EDC deliverySite managementData lock and audit readinessBudget managementRisk analysis and budget review
Right the First TimeEfficiency and compliance On-TimeSuperior delivery On-TargetBudget held, better decisions
Client Delight + Value + Trust = YES
$1.18BRWE bid opportunity lost in 19 months at one global provider (the principal's win-loss analysis)
69%of sponsors got a "B" team despite "A" team promises
70%worry team disruptions will stretch timelines
Satisfaction: Avoca Group, 2019 data (n = 85 to 93) · Worldwide Clinical Trials sponsor survey, 2024 (n = 140) · Ranking and mapping: the principal's Client Delight framework
Data Partnership Delay Rescue · Real-World Data, Executed

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.

Data Partners · Supply the Asset
  • Originated point-of-care data partners
  • Data infrastructure and tokenization partners
  • RWE analytics partners
Clinical TrialRx · Study Oversight Layer
  • Protocol stress-testing and feasibility
  • Site selection on real patient counts
  • Governance of monitoring and data lock
Sponsor · Receives a Delivered Study
~$800Kin sales reaching market sooner, for each day returned to the timeline (Tufts CSDD, Day of Delay white paper, 2024)
  • 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.

+27%Longer from protocol approval to first patient, 2010 to 2020
+37%Longer from first patient to last patient visit over the same years
$55,716Direct cost of one day of a Phase III trial

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.

Phase IRight patients found fast for first-in-human cohorts
Phase IIEligibility tested on real patients before the protocol locks
Phase IIISites chosen where the patients actually are
Phase IIIbLabel-expansion populations located early
Phase IV · RegistriesReal-world cohorts recruited at the point of care
Sources: Tufts CSDD, 2024 (Getz, SCOPE 2024; Smith, DiMasi, and Getz, 2024)
108 days back on the timeline Modeled per Phase III study
30days at start-up
40days of amendments avoided
38days earlier database lock

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.

See all six delay points and how each is fixed

Results · Anonymized

Three rescue patterns. One result each.

Sponsor and asset names are withheld. Every figure is reported as recorded.

Phase I to IV and RWE · Multiple therapeutic areas30+

The incumbent CRO was not performing.

Rescues brought back under Stage-Gate governance and CRO performance metrics.

 Clinical operations · Portfolio15 in 18 mo

A 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.
For Sponsors · CRO Oversight

Your CROs, working your way. Measured every month.

The metrics senior leadership sees
Right the First Time
98%fewer SOW and UAT set-up errors
Measured by% of SOW and UAT set-ups flawless
On-Time
38 daysdatabase locks ahead of schedule, on average
Measured bySite activation, enrollment, and first patient inSite visits to completed visit reports uploadedDays interim and final data sets and database locks land against schedule
On-Target
97%of studies closed within approved budget
Measured by% of studies within budget
Voice of the Client
78%rise in Voice-of-Client ratings
Measured by% increase in approval ratings

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.

See the full CRO oversight model

Right the First Time · 5-Stage-Gate Review System

One path from SOW to data lock. Every study, every month.

SOW
Pre-award
SOW and Bid

Protocol and SOW reviewed before the price is set

G1·G2
Award · KOM + 4 wks
Strategy and Plan

Team, scope, and schedule baselined

G3
First patient − 4 wks
Readiness

Sites, training, and risk log ready

G4
25% · 75% · last patient
Enrollment Checks

Reviews at every enrollment milestone

G4n
Data lock − 3 months
Lock Readiness

Data cleaned and queries closed early

G5
eTMF final − 4 wks
Close-Out

Audit-ready file and lessons learned

Weekly internal core teamWeekly client meetingWeekly budget review with financeMonthly review with leadership
SPONSOR SITE CRO THE PRINCIPAL

Every side of the table.

SponsorSelected and onboarded the CRO vendors
CROLed delivery and bid defense at top-five CROs and a leading central lab
SiteBuilt four research programs, all global top enrollers

"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
Donald Ray Cook, Principal Consultant at Clinical TrialRx
Donald Ray Cook, M.S., ML
Ed.D. Candidate
Principal Consultant and Strategic Client Advocate. Engaged directly on every sponsor partnership.
Principal Consultant · Head of Global Clinical Operations · RWE/RWD Rescue Practice

The sponsor's advocate at the table. Clinical TrialRx does not replace your CRO or do the work. The principal makes sure the work is done right, holding every partner to the plan you bought: Right the First Time, On-Time, On-Target, across Phase I to IV and RWE/RWD.

He has led Phase I to IV and RWE programs across 24,623+ patients, 1,092+ sites, and 30 countries, drove $302M in revenue growth in 19 months (a company record), and authored the system every engagement runs on: Service Value Added Model (SVAM) · Business Acquisition Process (BAP) · Business Execution Process (BEP) · 5-Stage-Gate Review System · Client Delight COE.

Sponsor, CRO, and site experience in one seat, delivered remotely with global remote teams, and on site whenever the engagement calls for it. Ed.D. Candidate, Leadership and Innovation, Purdue University. M.S., Management and Leadership, Purdue University.

54 / 157Direct / Dotted-Line Reports
Managed Globally Across FSP
27PIP-Graduates Mentored
to Full Performance · 100% Retention
4 + 4PM Centers of Excellence and
Clinical Trial Programs Built · All Programs Top Enrollers
FDA · EMA · PMDA · TGA · HSAFive Regulatory Authorities Engaged
Across Global Submissions
4 Start-Ups · 2 AcquiredStart-Up Advisory Record
Salesforce and Oracle Portfolios · Series Funded
AI/ML AdvisorLead Advisor · Global IP
First-Mover AI/ML Predictability Platform
Engage Clinical TrialRx

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 rescue assessment.

Start a Rescue Assessment Email Leadership Directly
Headquarters
2 East Main Street
Pittsboro, IN 46167
Remote delivery worldwide · on site when needed
Office
+1 (317) 799-0212
Direct: +1 (317) 491-2150
Leadership
drc@clinicaltrialrx.com