What counts
The result is better decision value
Activity is not an outcome. The relevant question is whether the program reaches its next decision with a more credible design, a more interpretable dataset, a more realistic execution path and a clearer basis for capital allocation.
+42%
faster FPI
Representative start-up acceleration in governed hub-and-spoke execution.
-28%
lower screen-fail rate
Representative improvement where protocol assumptions, site reality and patient selection were realigned.
5
continents
Multi-region experience connected through one governance logic.
Selected case snapshots
Six recurring points of exposure
Client identifiers are removed. Each case is summarized around context, constraints, intervention, outcome and the strategic implication.
Early development
Neurodegeneration readiness
Built an integrated path from early safety, biomarker and pharmacodynamic data to Phase II/III decisions, with explicit risk and evidence gates.
Pivotal design
Rare disease and complex CNS
Aligned endpoints, estimands, regulatory expectations, payer evidence, operational guardrails and differentiation into one pivotal architecture.
Trial rescue
Multi-country Phase II/III
Reset feasibility, country and site mix, activation cadence, vendor oversight and RBQM to stabilize enrollment and protect interpretability.
Evidence quality
RBQM reset for complex endpoints
Converted passive dashboards into actionable monitoring, site triage, rater control, escalation and sponsor-vendor decision rights.
Lifecycle evidence
Long-term safety and HEOR
Connected safety, durability, real-world evidence, patient burden and payer questions in a pragmatic post-treatment evidence roadmap.
Capital readiness
Financing and partnering
Built an integrated risk, evidence and mitigation narrative that contributed to financing and value-inflection discussions exceeding $50M across engagements.
The common failure mode
A protocol exists. The evidence architecture does not.
Across development stages and therapeutic areas, the same pattern recurs: medical rationale, regulatory strategy, payer logic, commercial positioning, safety governance and operational execution were never joined into one testable operating logic.
- Diagnose the assumption that most threatens decision value.
- Redesign the evidence path before activity compounds the error.
- Align decision rights, milestones and capital release.
- Govern execution so the answer remains interpretable at database lock.
Client and colleague perspective
The pattern others describe
The comments below concern Manolo’s contribution and working style. They are not claims that every mandate will produce the same quantitative outcome.
His contribution, commitment and professionalism have been truly outstanding.
Dr. Angelico Carta, MD
President & Co-Founder, Worldwide Clinical Trials
He quickly earned the reputation of the go-to expert.
Ram Yeleswarapu
Co-founder and past President/CEO, Navitas Life Sciences
A highly respected medical expert with deep, practical operational insight. Extremely rare and valuable.
Steve Galen, PhD
Former Global Head, Clinical Division, Navitas Life Sciences
Excellent European medical direction and guidance. I would work with him again in a heartbeat.
Arianna Pesci
Clinical Team Manager, Strategic Solutions
He stands out thanks to his originality of thinking and outstanding ability to give scientific contributions.
Mauro Manconi, MD, PhD
Head, Sleep & Epilepsy Center, Neurocenter of Southern Switzerland
Full collection
Read the anonymized case snapshots
The downloadable collection provides the context, constraints, interventions, outcomes and strategic implication for all six cases.
A decision-grade next step
Use the evidence before the next clinical money is committed.
Start with the decision or execution risk that most threatens the program’s next value gate.
