Phidealive is a full-service Italian CRO delivering end-to-end clinical trial solutions through a tailored, atelier-based approach. We design trial success from day one by combining rigorous scientific and therapeutic landscape assessment with operational, regulatory, and clinical expertise, ensuring solid, feasible, and strategically sound study designs. Alongside comprehensive CRO services, Phidealive offers advanced optional modules — including Real-World Data integration through wearable technologies — enabling sponsors to expand the depth, quality, and strategic value of clinical evidence when required.
Our philosophy is simple: fewer claims, more decision-grade evidence. We design studies as precision instruments, built to generate results that withstand regulatory scrutiny, operational reality, and strategic evaluation.
Our operating model reveals how trials are intentionally designed from day one — aligning feasibility, endpoints, and evidence discipline into a single strategic architecture.
> Enter the Atelier.
We begin with understanding, not templates: the clinical question, the biology of the intervention, and the patient reality. From this foundation, population, endpoints, and evidence strategy are constructed as one coherent design architecture. The protocol is shaped by the decision it must support, ensuring outputs that are clinically interpretable, scientifically defensible, and audit-ready.
As a Clinical Research Atelier, Phidealive can support sponsors across the entire study lifecycle — from regulatory and protocol strategy to execution and publication — or provide highly specialized expertise for selected phases only, including regulatory affairs, clinical operations, monitoring, project management, pharmacovigilance, data management, biostatistics, and medical writing.
Founded in Milan in 2018, Phidealive was created with a clear ambition: to combine rigorous GCP discipline with an atelier-based approach to designing and delivering clinical research. Built on strong operational foundations, we evolved into a broader clinical partner by strengthening the phases where trials are truly shaped — feasibility, therapeutic landscape insight, and decision-led study architecture.
Today, Phidealive operates as a Clinical Research Atelier where scientific strategy, regulatory intelligence, and operational excellence converge. When appropriate, we offer advanced optional modules — including wearable-enabled longitudinal data, high-frequency ePRO, and real-world evidence approaches — always grounded in methodological rigor and data integrity.
Our perspective is informed by decades of clinical research culture and experience, rooted in an early-generation CRO environment and carried forward through a new model designed for today’s evidence standards. The goal remains pragmatic: credible, decision-ready evidence, delivered with responsibility at the center of every service.
Because trials are strategic assets, not operational tasks.
Sponsors choose Phidealive when they need more than execution — when they need a partner able to design, lead, and successfully deliver studies that generate credible, decision-ready evidence.
Phidealive partners best with organizations that see clinical research as a strategic decision-making tool — not just a regulatory step.
Because trials are strategic assets, not operational tasks.
Late-phase execution: operational control, RBQM, inspection readiness, and scalable delivery.
Early-stage decision support: endpoint strategy, feasibility-first design, credible evidence packages.
Investigator-initiated trials: governance, compliance support, and publication-grade evidence.
Academic / University: governance, compliance support, and publication-grade evidence.
Academic / Food supplements: governance, compliance support, and publication-grade evidence.
Medical devices: governance, compliance support, and publication-grade evidence.
We design trials from decision logic and execution realities — then structure the service model to ensure they run smoothly and reach completion without avoidable rework..
Tell us where you are. We’ll help define the path forward
Begin yoursFor late-phase and complex programs, success depends on disciplined execution: predictable delivery, risk-based oversight, and evidence packages that remain interpretable under pressure.
Milestone discipline, proactive risk tracking, and amendment minimization.
Risk-based quality oversight with documented rationale and escalation pathways.
Centralized review loops to protect endpoint integrity and reduce surprises.
Audit trails, controlled documents, and consistent decision logs.
Supporting complex clinical programs across Europe
Add a continuous, patient-centric data stream (activity, sleep, cardiometabolic signals) without changing the core trial structure— as exploratory endpoints or supportive evidence.
Objective trends that contextualize visit-based outcomes.
Fatigue/performance markers aligned with real-life function.
Governed pipelines and analysis-ready features.
Designed for early programs where the first study determines the next round.
Not generic end-to-end services. Concrete outcomes sponsors care about in early-stage programs. Pragmatic protocol and endpoint choices that reduce avoidable amendments. Evidence built to support go / no-go decisions—without unnecessary complexity. Defensible endpoints and measurement plans aligned with likely EMA/FDA questions. Operational models designed for constrained resources and evolving timelines. Share your program goals. We’ll respond with a focused set of next steps.What you get (commercially clear)
Fewer redesigns
Earlier clarity
Regulator-aware
Feasible execution
How we work
Talk to us
Define evidence route (clinical investigation, literature, equivalence, PMCF) with clear rationale and gaps mapping.
Keep performance/safety claims consistent with intended purpose, risk class, and available evidence strength.
Feasible protocols for device performance: endpoints, comparators, workflow integration, and bias control.
Use-related risk framing, validation planning, and documentation that supports safe use in real settings.
Post-market plans, registries/RWE options, and signal review workflows aligned with ongoing compliance.
Clinical evaluation report inputs, study reports, traceability matrices, and decision logs suitable for audits and NB review.
Ideal when you need smoother notified body dialogue and a stronger, coherent clinical evaluation narrative.
Universities and research hospitals run complex studies with limited operational bandwidth. We provide a pragmatic support layer that strengthens ethics/regulatory readiness, data integrity, and reproducibility—without turning academic work into “CRO bureaucracy”.
We design study deliverables built for ethics approval, scientific credibility, and publication.
Roles, SOP-lite documentation, oversight plans, and decision logs that are auditable.
Clinically readable endpoints, feasible schedules, and analysis-ready definitions.
eCRF design, edit checks, traceability, and review workflows to prevent post-hoc fixes.
Submissions packs, amendments discipline, and rationale trails for committees and authorities.
Pre-specified analysis plans, missingness strategy, and publication-ready outputs.
Registration, structured results, and documentation consistent with open science expectations.
Ideal when your study must be robust enough for high-impact publication, funder scrutiny, or future sponsor interest.
IITs require the same discipline of sponsor-led trials—without the same infrastructure. We support investigators and institutions with compliance-grade operations, data integrity, and publication-ready evidence packages.
Roles, responsibilities, oversight plans, and controlled documentation.
Feasible design, defensible endpoints, and analysis-ready definitions.
CRF/eCRF logic, auditability, traceability, and data review workflows.
Submissions support, amendments discipline, and clear rationale trails.
Site processes, monitoring approach, risk-based quality controls.
CSR-like reporting structure aligned with journals and transparency.
Built for IITs that must stand up to sponsor, regulator, and journal review.
Food supplements win when formulation, endpoints, and communication are aligned with what is defensible. We support brands and manufacturers with pragmatic evidence strategy, compliant claim framing, and study packages that reduce regulatory and reputational risk.
Translate positioning into compliant language, consistent with ingredient roles and evidence strength.
Structured landscape review: what exists, what is credible, and where the gaps are for your formulation and target population.
Feasible protocols for real-life use: endpoints, duration, adherence, and confounder control without overengineering.
Traceable rationale for composition, dose, and safety; change control logic and supplier/document consistency.
eCRF/ePRO setup, edit checks, and analysis-ready datasets to avoid “last-minute” reporting crises.
Clear outputs: protocol synopsis, statistical plan, and readable reports suitable for internal QA and external dialogue.
Ideal when you need to launch/scale with fewer regulatory surprises and a stronger evidence narrative.
We do not sell a “long list of indications”. We apply the same operating discipline across areas: feasibility-first design, clinically readable endpoints, and governance that protects evidence quality.
Endpoint clarity, trial feasibility, supportive evidence with RT-RWE layers.
CV outcomes, rhythm burden, functional capacity and patient-centric metrics.
Longitudinal burden, functional endpoints, digital markers where relevant.
Inflammatory pathways, pragmatic endpoints, variability-aware design.
Time-critical feasibility, evolving standards, operational speed with control.
Adherence-sensitive measures, QoL proxies, real-life function alignment.
Small populations, high variance, endpoint robustness and interpretability.
Symptoms-to-function linkage, between-visit visibility when appropriate.
The therapeutic area changes details—not the discipline.
Send your indication and phase; we’ll reply with a focused fit assessment.
Send a short note. We respond with focused feedback — not generic replies.
If you work in clinical operations, data, statistics, medical writing, or digital endpoints, send a short profile and what you want to build.
