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Ethimark — Rooted Ethics Through Generation

Our services

End-to-End Clinical Development Support

Integrated expertise across the entire clinical research and drug safety lifecycle, from first protocol to post-marketing safety.

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Clinical Development

Development planning, protocol design, medical writing, KOL engagement and statistical planning.

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Clinical Operations

Phase I–IV trial operations from feasibility and site start-up to monitoring, recruitment and close-out.

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Project Management

Dedicated project managers who own planning, risk, vendor oversight and transparent reporting.

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Regulatory Affairs

Regulatory strategy, submissions and lifecycle management across global health authorities.

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Pharmacovigilance

Case processing, literature monitoring, aggregate reports, signals, risk management, QPPV and PSMF.

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Medical Device Safety

Vigilance and post-market surveillance for device and IVD manufacturers under EU MDR, IVDR and FDA.

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Medical Writing

Scientific and regulatory medical writing for clinical research, from study documentation to clinical reports and publication support.

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Third-Party Medical Monitoring

Independent medical oversight to support participant safety, clinical decision-making and protocol compliance.

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Protocol Writing

Structured clinical study protocols designed around study objectives, endpoints, participant safety and regulatory requirements.

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Biorepository & Sample Management

Organized biospecimen handling, processing, storage and retrieval to support clinical research requirements.

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Third-Party Archival Facility

Secure storage, organization and retrieval of essential clinical research records and study documentation.

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Quality Control

Quality checks and documented review processes to support accurate, consistent and compliant clinical research activities.

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Quality Assurance

GCP and GVP audits, QMS development and inspection readiness for clinical and PV activities.

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Flexible engagement models

Built Around Your Goals

We adapt to the way you work. Whether you need a single specialist, a dedicated functional team or complete ownership of a multi-country program, our engagement models are built around your goals, timelines and budget.

End-to-End Delivery

One accountable partner managing your study from design and start-up through close-out and reporting.

Functional Outsourcing (FSP)

Dedicated, trained resources embedded in your processes, giving you continuity and control while we handle recruitment, training and oversight.

Expert Consulting

Senior advisors for specific challenges: development strategy, regulatory pathways, safety system design, audit readiness and more.

Let’s work together

Ready to Start Your Next Study?

Tell us about your program and our experts will get back to you with a tailored approach and proposal.

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