We’ll focus on earning approval so you can bring your device to market faster.

Medical Devices

Full-Scope Services

Medical Device Feasibility Platform

Cohortias’ team of monitors, auditors and experienced clinical research professionals provide comprehensive support, from planning to post-market data collection.

Full-Scope Services

Phase 1

Before – Study Strategy

Clinical trial compliance starts with a strong strategy. Cohorias assist our Sponsors by establishing study protocols, developing a risk-based study plan and training the study team to ensure human subject protection and data integrity.

Phase 1

Phase 2

During – Study Management

Managing all the moving parts of a medical device trial can be stressful. Cohortias take on the load by assisting with monitoring, data entry, vendor management, safety management and more.

Phase 2

Phase 3

After – Study Conclusion

Cohortias provides your study with final audits, data lock & analysis and any corrective action if your study receives action items/warnings from regulatory entities.

Phase 3

Experience

Methodology

Cohortias is medical device CRO with proven experience ensuring patient protection, data integrity and regulatory compliance at every stage in the clinical research process.

Experience

Clinical Services at Every Stage

Feasibility
Platform

As a full-service medical device CRO, Cohortias  assists sponsors with conducting well-controlled, compliant, clinical research studies.  We are proud to contribute to the clinical research community with our infrastructure in Latin America, which allows Sponsors to conduct their studies for a fraction of the cost compared to the US medical device CRO market.

Our platform was developed to guide and manage teams through the entire clinical trial lifecycle. Our team assists with specific tasks at any point in the process, providing independent monitoring, regulatory filing, auditing, consulting, data management and safety compliance services.

Services Included

01

Site Management

02

Regulatory Filing

03

Monitoring & Data Management

04

Auditing & Safety Monitoring

Therapeutic Area Expertise

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