Evidence that holds up, from protocol to publication.
Evidence programmes work best when protocol, conduct and publication sit in one governed ecosystem. We run the full arc on ECS®, our validated virtual research ecosystem, so sponsors get one accountable partner, one dataset and one defensible dossier.
Sponsors come to us for three things: evidence that holds up, timelines that hold, and a dossier they can take to market with confidence.
One team, named and accountable, from protocol to publication.
Research happens where people meet.
A participant who agrees to share part of their life. A clinician who listens before measuring. A scientist who decides what the data means. Those three meetings are the study. Our services exist to serve them, and they are delivered by people who chose this work and stayed in it — and the people accountable for your study stay with it from kick-off to close.
Before, during and after the study.
Most CROs start when the protocol is set and stop when the last patient leaves. We work the whole arc. Each entry links to the page where the full depth lives.
Shaping the evidence.
Defensible claims and defensible protocols start long before enrolment. We define what needs proving, and design the path to prove it.
- Evidence strategy & study designMap the evidence path, position the product scientifically, and design protocols and endpoints across every domain and product class.
- Protocol development & scientific writingTurn your idea into a regulator-ready protocol, rigorous, defensible, submission-grade.
- Regulatory strategy, submission and market accessRoute to approval and route to reimbursement: feasibility, EMA/FDA and MDR/IVDR pathways, submissions, HEOR and payer dossiers.
- GCP training, sites & sponsor staffICH E6(R3) training and site readiness for clinical sites and their investigators and coordinators, plus sponsor study teams, including nutrition & CHC.
- Claim strategy & substantiationDefensible claims and the evidence they require, aligned to EFSA/FDA and consumer-health frameworks.
- Advisory boards & KOL / HCP managementCurated expert panels, KOL mapping and scientific advisory, where clinical insight shapes design.
- AIRA insight, advisory & AIThree service lines: Advisory, Insight Generation and AI Applied, from research strategy to AI-assisted reads.
Conducting the study, where the participant is.
Interventional and post-market studies run end-to-end on ECS®, with monitoring, safety & vigilance and quality built in.
- Clinical Trials (interventional, DCT / hybrid)Interventional and post-market studies run end-to-end, centralised, hybrid or fully virtual.
- Real-World Evidence & observationalRetrospective, prospective and ambispective studies · patient registries · EHR-based research · observational and PSPs, on ECS®.
- Direct-to-Participant & decentralised servicesHome delivery, home visits, telehealth and remote eConsent, investigator-supervised via ViSA.
- Patient recruitment & retentionPHYGITAL-CROWD and the Armonia Research Community turn engaged people into enrolled participants.
- Patient experience & concierge supportLucaH®, white-glove participant support and continuous engagement, from interest to last visit.
- Monitoring & RBQMQuality by design across the whole study, not monitoring alone: risk assessment, on-site, remote and centralised oversight against your risk plan, corrective actions tracked on ViSA.
- Safety, vigilance & quality by product classSafety monitoring and vigilance, pharmacovigilance, materiovigilance, cosmeto- and nutrivigilance applied per product class, with ISO 9001 quality assurance across the study lifecycle.
- IP & study supplies managementInvestigational product and supplies, GMP labelling, IRT, release, chain-of-custody and reconciliation, governed on ECS®; distribution via qualified GDP depots.
One D-T-P network across hospitals · community HCPs · pharmacies · home · communities. How the Direct-to-Participant model works →
Turning results into evidence.
Results are not evidence until someone can act on them. We write, submit, publish and defend.
- Biostatistics & data managementSample size, SAP, statistical programming and clean, analysis-ready CDISC data.
- Medical & scientific writingStudy reports, manuscripts, abstracts, lay summaries and dossiers, with publication planning and scientific communication that carries the evidence forward.
- AI Applied, synthetic & external control armsModel-generated cohorts, historical comparators and AI-assisted reads, governed for regulatory defensibility.
Named specialists on the study, from the first meeting to the final report.
One accountable team follows the study across initiation, conduct and closing, extended by a qualified vendor and partner network, all resting on our QMS and digital infrastructure.
Study initiation
Core roles
Business development, start-up success manager, lead medical writer, lead data manager, lead biostatistician, regulatory specialist, EDC developer.
Study conduct
Core roles
Clinical research associates, enrolment specialist, remote data monitor, concierge service lead, quality assurance manager.
Study closing
Core roles
Medical writer, clinical research associates, lead medical writer, lead data manager, lead biostatistician.
Three ways to work with us.
Evidilya runs the study end-to-end on ECS®, from protocol to publication. One accountable partner.
Fit: A new evidence programme, Direct-to-Participant by design
You keep your systems and your sites; our senior specialists run the study, or embed inside your team (FSP) for named functions, or advise as a defined consultative engagement.
Fit: An in-flight study, or a decision to de-risk before committing to one
Your team runs the study; ECS® is the validated, supported virtual research ecosystem underneath. No full-service required.
Fit: Sponsor or CRO with in-house operations
You have the idea. We give you the CRO engine, à la carte, to design, run and publish.
Every step of the participant journey, visible to your team, in real time.
Because it runs on ECS®, awareness, pre-screen, referral, consent and retention live in one dashboard, live as the study runs.
Some of our work is public. The rest lives under NDA, ask us.
Published composites show how we design and run studies, with no client named and no exact metric disclosed. Under NDA we walk you through the programmes closest to yours: design, cohort, retention and what we'd do differently.
Tell us about your study.
We'll bring the team, the sites and the methods, and run it on ECS®.