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
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Clinical TrialRx · Study Oversight Layer
- Protocol stress-testing and feasibility
- Site selection on real patient counts
- Governance of monitoring and data lock
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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)
$107M
New Business from Existing Clients
Won above plan at a top-five global CRO from existing clients who chose to do more after Client Delight delivery.
45%
Amendment Cycles Cut
Rescue-trial amendment cycles, through systematic literature review and real-world data-lake strategies.
38 days
Data Locks Ahead
Average interim and final data locks ahead of schedule.
30%
Efficiency Gain
In an underperforming clinical operations division, with 15 high-priority trials delivered in 18 months through AI-driven analytics and adaptive designs.
Delay Point 01 · Feasibility & Protocol
Feasibility and protocol design
76%of protocols are amended · Tufts CSDD, 2024
Where it breaksEligibility criteria are written for patients who are rare in practice.
What we doTest eligibility, visit burden, and endpoints against real patients before first patient in.
Delay Point 02 · Sites
Site selection
62%Only this share of sites approached ever activate · Tufts CSDD, 2024
Where it breaksSites are chosen from surveys that overstate available patients.
What we doRank sites by real patient counts and past enrollment, not survey answers.
Delay Point 03 · Enrollment
Enrollment
Where it breaksShortfalls are found after the enrollment window is already lost.
What we doForecast site-level enrollment from real-world data and flag shortfalls early. Work with partners to identify likely eligible populations near active sites, using de-identified, tokenized data under each partner's privacy, consent, and IRB-approved recruitment framework.
Delay Point 04 · Amendments
Amendments
Where it breaksEach amendment cycle runs 260 days, and one Phase III amendment carries a $535K median direct cost (benchmarks above).
What we doEvery amendment avoided at design removes a cycle from the timeline. Tufts CSDD estimates a day of delay costs about $40,000 in direct Phase II and III trial cost and about $800,000 in lost prescription sales (2024).
Source: Smith, DiMasi, and Getz · Ther Innov Regul Sci · 2024
Delay Point 05 · Rescue
Rescue
Where it breaksA late trial has no evidence of why it is late.
What we doRun the existing rescue method (VOC and Seven Pains audit, Stage-Gate governance, FSP oversight) with the data partner layer alongside it, to re-forecast enrollment, re-target sites, and reset the plan on real numbers.
Delay Point 06 · Lifecycle
RWE is not a phase
Where it breaksReal-world evidence is treated as a post-market afterthought.
What we doCarry the same real-world data from feasibility through Phases I to IV and post-market, so external controls, label expansion, safety surveillance, and payer evidence draw on one consistent evidence base. See the RWE Doctrine.
Platform to Science
The translator between the platform and the science.
Data platforms are bought for what they promise; studies are judged by what they deliver. In prior roles, the principal has taken CTMS, EDC, monitoring software, and AI/ML from purchase into live operation, including a global CTMS implementation across 21 international affiliates. In RWE leadership roles, that work extended to direct review of the underlying program data: living reviews of global registries and claims databases, and orphan-disease burden estimates built for regulatory-grade submissions.