Why Colombia, offers Unparalleled Benefits For MedTech Clinical Studies
Subject Recruitment
+52 million population with access to the best universal healthcare system in Latin America ensures a large and diverse subject pool with high enrollment rates.
Competitive Costs
Savings of about
%
Over trials costs in the US or Europe
Regulatory Pathway
MoH INVIMA takes
Days (after IRB/EC approval)
Clinical Research
Over 140 active ICH/GCP-certified research sites with world-class infrastructure, technology, and equipmentaspecto. Fast, Reliable and High-Quality
We offer comprehensive support throughout all research phases
Phase 1: Initial Assessment
We work closely with researchers and sponsors to design safe and effective study protocols in this initial phase. We provide:
- Guidance on selecting initial dosages.
- Rigorous safety monitoring.
- Detailed data management to evaluate pharmacokinetics and pharmacodynamics.
Phase 2: Preliminary Efficacy Evaluation
We continue to support researchers and sponsors in assessing the efficacy and safety in patients with the target disease. We offer:
- Data management to assess treatment response.
- Monitoring of side effects and clinical response.
Phase 3: Confirmation of Efficacy and Safety
We coordinate multicenter trials and ensure compliance with all regulations and Good Clinical Practices (GCP). We provide:
- Large-scale data management.
- Rigorous study quality monitoring.
- Support in data collection to support regulatory approval.
Phase 4: Post-Approval Studies
We collaborate on post-approval studies to monitor the long-term safety and effectiveness of treatments in real clinical practice. We offer:
- Ongoing assessment of long-term safety.
- Identification of rare or delayed side effects.
Furthermore, we provide a suite of specialized healthcare services to address a wide spectrum of clinical research needs.
Protocol Design
We create detailed study protocols
Site Selection
Participant Recruitment
Data Management
We ensure high-quality data
Rigorous Clinical Trial Monitoring
Regulatory Compliance
Ethics and Participant Safety
We subject the protocol to thorough ethical review
Reporting and Publication of Results
With Investigators
With Sponsors
Effective Communication, Resource Management, Regulatory Compliance and Detailed Reporting
With Allies or Partners
Effective Coordination, Utilization of Shared Resources, Synchronization Meetings
Allies
