Our Services
Study Design & Protocol Development
CRA Service
- Assistance in writing study protocols, informed consent forms, and case report forms (CRFs)
- Regulatory strategy and scientific consulting
- Feasibility assessments (including patient recruitment projections)
Regulatory Support
CRA Service
- IND/IDE submissions (FDA, EMA, etc.)
- Ethics Committee/IRB submissions
- Audit readiness and regulatory compliance guidance (GCP, ICH, etc.)
Site Selection & Management
CRA Service
- Identification and onboarding of clinical trial sites
- Site contract negotiation and budget management
- Site training and monitoring support
Patient Recruitment & Retention
CRA Service
- Development of patient recruitment strategies
- Use of digital marketing, EHR databases, and referral networks
- Patient engagement and retention tools
Clinical Trial Operations
CRA Service
- Study startup services
- Project management and coordination
- Monitoring (remote and onsite), data entry, and query resolution
Data Management & Biostatistics
CRA Service
- EDC (Electronic Data Capture) system setup and management
- Data cleaning and validation
- Statistical analysis and reporting
Technology Enablement
CRA Service
- ePRO (electronic patient-reported outcomes) platforms
- Wearables, remote monitoring, and decentralized trial technology
- Clinical trial management systems (CTMS)
Funding & Partnerships
CRA Service
- Support in grant writing, investor pitches, and strategic partnerships
- Access to venture capital, accelerators, or public-private partnerships
- Collaboration opportunities with academia and pharma companies
Training & Education
CRA Service
- Good Clinical Practice (GCP) training
- Investigator and coordinator training
- Workshops or courses in clinical research operations
Quality Assurance & Risk Management
CRA Service
- Quality Management System (QMS) setup
- Risk-based monitoring planning
- Audit support and CAPA (Corrective and Preventive Action) plans
What We Do
-
01
End-to-End
Clinical Trial Support -
02
Local Expertise
Global Standards -
03
Site & Patient
Access -
04
Innovation
Enablement -
05
Regulatory & Data
Services -
06
Accelerate
with Purpose
End-to-End Clinical Trial Support
We offer full-service operational support to help you plan, initiate, and manage clinical trials with precision and speed. From protocol development to patient follow-up, our experienced bilingual team ensures compliance, efficiency, and data integrity every step of the way.
Local Expertise, Global Standards
We navigate the complex regulatory environments of Latin America—COFEPRIS (Mexico), ANVISA (Brazil), INVIMA (Colombia), DIGEMID (Peru)—with deep regional knowledge and a commitment to ICH-GCP and international best practices.
Site & Patient Access
Through our growing network of certified clinical research sites and hospitals, we connect sponsors with treatment-naïve, diverse patient populations and high-performing investigators. We optimize recruitment and retention using culturally adapted, community-driven engagement strategies.
Innovation Enablement
We integrate digital tools and decentralized trial models tailored for Latin America’s realities—offering eConsent, ePRO, telemedicine, mobile health units, and real-time data dashboards to streamline your research and reach underserved areas.
Regulatory & Data Services
We manage submissions, ethical approvals, and site contracts while ensuring your trial data is secure, compliant, and submission-ready. Our team also provides data management, biostatistics, and medical writing support with local and global regulatory alignment.
Accelerate with Purpose
Whether you're launching a Phase I oncology trial or scaling a Phase III infectious disease study, we accelerate your timeline while reducing cost and complexity—helping you bring life-changing therapies to patients in Latin America and the world.
Add your request and get valuable feedback from our talented consultants.
Submit your request and receive valuable feedback from our team of experienced consultants. Whether you're facing a challenge, looking for advice, or seeking fresh perspectives.