Sponsors & CROs
A clinical execution partner on two continents
From feasibility to study close-out, we provide prepared sites, experienced teams and high-quality data for your clinical programs.
Services
Phase I–IV studies
Study execution from first-in-human safety trials through post-marketing studies.
Phase I and bioequivalence
Studies in healthy volunteers, pharmacokinetics and comparison of generics against the reference product.
Feasibility
Analysis of available populations, competing studies and regulatory timelines by country before committing to targets.
Site selection and activation
Assessment of investigators and infrastructure, contracts, budgets and site initiation visit.
Recruitment and retention
Proprietary databases, physician referrals, community outreach and participant support.
Site management (SMO)
Standardized coordinators, investigators, pharmacy and documentation across the entire network.
Regulatory affairs
Preparation of submissions to FDA, COFEPRIS, INVIMA and ARCSA, and management of amendments.
Ethics committees / IRBs
Coordination of submissions, renewals and reports to ethics committees and IRBs.
Data and monitoring
Electronic data capture (EDC), timely query resolution and readiness for monitoring and inspections.
Pharmacovigilance
Recording and reporting of adverse events within regulatory timelines.
Hybrid studies
Home visits, telemedicine and digital tools when permitted by the protocol.
Investigational product logistics
Importation, cold-chain storage and sample shipment, in synergy with Nexus Global Group.
Site capabilities
- Dedicated research exam rooms
- Controlled storage: ultra-low freezer, freezer and refrigerator
- Centrifuges and sample processing
- 12-lead electrocardiography
- Life-support equipment and CPR-certified staff
- Physician available 24 hours a day for participants
- Staff trained in Good Clinical Practice (GCP)
- Backup power generator
Why Nexus Medical?
A single point of contact
We coordinate every site in the network so that you work with a single counterpart.
Confidentiality from day one
A confidentiality agreement before the protocol is shared, with access to information limited to the essential team.
Diverse populations
Access to Hispanic patients in the United States and Latin America for more representative studies.
Consistent quality
Standard operating procedures and internal quality controls in every country.
Planning a clinical study?
Let's talk feasibility, timelines and target populations. We sign confidentiality agreements before receiving any information about your protocol.