First Integrated Network · Ibero-America

The future
of care delivered
today.

The largest integrated clinical research site network in Ibero-America - one SOP, one unified CTMS, one governed quality system across 10 countries. Not a marketplace of contracted sites. One network, one oversight model.

30+
Precision medicine centers
10 countries
Active trial operations
80+
Principal investigators
13+
Active Tier-1 sponsors
ICH E6(R3)
GCP aligned · all sites
21 CFR Part 11
Data platform standard
≤48h
Feasibility response time
Phase I–III
Trial capability
ES / EN / PT
Language support
Why Celerity

Built on integration, governance and depth - not headcount.

Not a marketplace of contracted sites. One network, one oversight model - a single SOP, one unified CTMS, and one governed quality system across every country at once.


No subcontracted site networks. No quality gaps between countries. One point of contact for your entire program.

Integration
Your monitor meets the same processes and the same documentation in every country. One operating standard end to end - no protocol-variation surprises between borders, no relearning each site.
Governance
Not subcontracted. The standard is enforced across the network rather than hoped for site by site - exactly what closes the quality gaps fragmented engagements leave open.
Depth
An anchor in oncology and precision medicine, backed by a real, active multi-therapeutic portfolio - so the network can carry a program, not just a single indication.
The problem we solve

Multi-country trials shouldn't mean multi-country risk.

Contracting individual sites across several countries leaves a sponsor holding several quality systems, several data trails, and the oversight burden ICH E6(R3) now expects them to actively manage. Celerity removes the seams.

Fragmented sites
The status quo
  • A different SOP, training standard and audit trail at every site
  • Quality gaps between countries the sponsor must detect and close
  • Disconnected systems - no single source of truth for oversight
  • Each contract, submission and timeline negotiated in isolation
One integrated network
The Celerity model
  • One SOP and one training standard applied at every site
  • One governed quality system - no gaps between countries
  • One unified CTMS as the single system of record
  • One point of contact coordinating submissions in parallel
One standard, in practice

What a single governed system gives you.

Unified SOP Framework
One set of standard operating procedures across all countries. Same training, same documentation, same audit trail regardless of where a site sits.
One Unified CTMS
A single system of record across the network - enrollment, queries and deviations visible in one place, so oversight doesn't depend on stitching reports together.
Owned, Governed Network
No subcontracted site chains. The quality standard is enforced centrally, which is precisely how the gaps between countries get closed.
Site Network

10 countries.
One standard.
One network.

Every Celerity site operates under the same SOP framework, the same training standards, and the same reporting infrastructure. Your monitor visits every country with zero protocol variation surprises.


View full site directory →
Chile
Chile
Peru
Peru
Colombia
Colombia
Mexico
Mexico
El Salvador
El Salvador
Ecuador
Ecuador
Spain
Spain
Argentina
Argentina
Bolivia
Bolivia
USA
USA
30+
Precision medicine
centers active
80+
Principal investigators
across network
1
SOP framework
across all sites
7
Regulatory agencies
managed in-house
Europe · Expansion

A bridge from Ibero-America to the European standard.

Celerity's network is expanding into Europe through Spain, giving sponsors a governed on-ramp to the EMA standard under the same single quality system that runs across Ibero-America. Deployment begins in Málaga through agreements with HM Hospitales, a national hospital group.

Why it matters

High-volume Pacific and Andean enrollment and a European bridge to EMA-standard data - combined under one network and one oversight model. A footprint built on integration, not assembled per study.

Note: Spain is presented as an expansion of the site network and a clinical bridge - not as a CRO service offering.

Quality & Compliance

Built for sponsors who don't accept excuses.

Metric
Standard
Status
Feasibility Response
≤48 hours
Active
GCP Compliance
ICH E6(R3)
Aligned
Data Platform
21 CFR Part 11
Compliant
Monitoring
On-site + Remote
Hybrid
Language Support
ES / EN / PT
All sites
Regulatory Affairs
In-house per country
All 7
Pharmacovigilance
Integrated reporting
Active
What this means for you

Every process documented.
Every site auditable.

24-hour audit notice accepted at any site. Single source of truth across all 10 countries.

Real-Time Sponsor Dashboard
Enrollment progress, query resolution, and protocol deviations visible 24/7 - without waiting for weekly reports.
Central Lab Coordination
Pre-negotiated agreements with regional central labs. Sample logistics, cold chain, and LIMS integration handled in-house.
ICH E6(R3) - Aligned & Ready
Built to the current GCP standard: Annex 1 (interventional trial conduct) in force since July 2025, and Annex 2 (decentralized trials, real-world data & RBQM) adopted June 2026 - applied uniformly network-wide.
Regulatory Landscape

Approval timelines across our network.

Each country has distinct requirements. Our in-house teams navigate them so you can focus on science.

ISP · ChileActive
Instituto de Salud Pública
60–90d
Typical approval timeline
Network headquarters and fast-start regulatory jurisdiction.
DIGEMID · PeruActive
Dirección General de Medicamentos
90–120d
Typical approval timeline
High-volume market operated from Lima.
COFEPRIS · MexicoActive
Comisión Federal para la Protección contra Riesgos Sanitarios
TBD
Timeline pending verification
High-volume market operated from CDMX.
INVIMA · ColombiaActive
Instituto Nacional de Vigilancia
90–120d
Typical approval timeline
High-volume market. Oncology & immunology focus.
MSP · EcuadorActive
Ministerio de Salud Pública · Comités de Ética
60–90d
Typical approval timeline
JV with SOLCA Ecuador adds oncology infrastructure depth in Quito. Guayaquil & Cuenca expanding.
AEMPS · SpainEMA Gateway
AEMPS · CEIm · CTIS
EU CTR
National CTA via CTIS · EMA-standard data
Celerity's bridge to EU market access, via HM Hospitales starting in Málaga.
Therapeutic Areas

Where we operate.

Full specialties list →
Oncology
Solid tumors, hematologic malignancies, immuno-oncology. Largest patient pool in the network. Phase I–III capability with experienced investigators.
Core specialty · Phase I–III
Cardiometabolic
Cardiovascular, type 2 diabetes, MASH/NASH, obesity. High-prevalence treatment-naive pools across Latin America.
High enrollment potential
Immunology
Autoimmune diseases, IBD, psoriasis, rheumatoid arthritis. Investigators with international advisory board experience.
Active Phase II–III
CNS & Respiratory
Schizophrenia, depression, COPD, asthma, idiopathic pulmonary diseases. Specialist infrastructure across key sites.
Expanding capacity
Study Process

From feasibility to first patient in.

Streamlined, transparent, and sponsor-managed at every stage.

01
Feasibility Request
Submit protocol synopsis. Response within 48 hours with site-level enrollment estimates and regulatory timelines per country.
02
Site Selection
Pre-qualification packages, PI CVs, facility specs. Parallel submission readiness across all selected countries from day one.
03
Regulatory & IEC
In-house regulatory teams manage country-specific submissions. IEC/IRB tracking visible in the sponsor portal.
04
Site Activation
Standardized SIV protocol. Staff training, IMP receipt, lab kit distribution. Activation metrics tracked in real-time.
05
Enrollment & Close
Pre-screened patient activation, continuous monitoring, query management. DBL support and CSR contribution on request.
Start Here

Submit your protocol.
We respond in 48h.

Our feasibility team will respond within 48 hours with site-level enrollment estimates, investigator profiles, and regulatory timelines across your selected countries.

Feasibility response in ≤48 hours
Site-level enrollment estimates per country
Investigator CVs and facility documentation
Regulatory timeline by country
Confidential - NDA-ready on request
No obligation to proceed
Request Feasibility Assessment
For sponsors, CROs, and biotech partners.
Request received.
Our feasibility team will respond within 48 hours with enrollment estimates and regulatory timelines.
Ready to evaluate your feasibility
across Ibero-America?
Request Feasibility → Download Capabilities Deck