CLINMARK


Clinmark is a contract research and consulting organization with over 23 years of experience in global clinical research. They focus on turning concepts into final deliverables, offering flexible, global, and diligent services. Their mission is to support pharmaceutical and biotech companies in research, development, and clinical trials, ensuring high-quality standards and compliance with regulatory guidelines. They aim to be a reliable partner in advancing medical research and improving patient outcomes.

Industries

biotechnology
consulting
pharmaceutical

Nr. of Employees

small (1-50)

CLINMARK

Warsaw, Indiana, United States, North America


Products

Contract Research and Consulting Organisation

Clinmark offers flexible and global contract research organization (CRO) services with expertise in clinical research across multiple regions worldwide.

FSP – Contract Research and Consulting Organisation

Clinmark offers a three-pillar Functional Service Provision (FSP) model customized to Client’s needs, providing access to quality people only when needed and saving on recruitment and training costs.

CRO Services

Clinmark provides high-quality clinical research services including protocol writing, data monitoring, medical monitoring, project management, and final report preparation for medical products and medical device trials.

Medical Device Trial Conduct Services

Full service of medical device trial conduct, including protocol design and writing, data monitoring, medical monitoring, project management, and preparation of the final report.

Comparator sourcing

Procurement and sourcing service for pharmaceutical products directly from manufacturers or trusted suppliers, supplying Reference Listed Drugs (RLDs) for clinical studies worldwide.

Pharmacovigilance & Drug Safety Services

Clinmark provides comprehensive pharmacovigilance and drug safety services including adverse event reporting, safety monitoring during clinical trials and post-market, preparation of safety reports, risk management plans, and regulatory support.

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Services

End-to-end operational support for clinical trials including protocol development, monitoring, medical monitoring, data management, biostatistics and final study reporting.

Rapid-response services to recover underperforming studies, including recruitment acceleration, retention programs, quality oversight, data integrity remediation and inspection readiness.

Procurement and supply chain management for investigational medicinal products and reference listed drugs across multiple markets, delivered to GDP standards.

GCP/GMP/GXP audits, mock inspections, CAPA implementation and continuous quality oversight to support compliance and inspection readiness.

Regulatory pathway planning, CE marking/MDR and FDA support, conformity assessment assistance and due diligence for medical devices and drugs.

Training programs on ICH GCP R3 and expert reviews of clinical processes, CRF design and audit trails to optimize documentation and compliance.

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Expertise Areas

  • Clinical trial management (Phases I–IV)
  • Study design and protocol development
  • Patient recruitment and retention
  • Clinical data management and EDC
  • Show More (10)

Key Technologies

  • Electronic data capture (EDC) systems
  • Telemedicine platforms for decentralized trials
  • Wearable sensors and remote patient monitoring
  • Clinical data management systems
  • Show More (6)

News & Updates

Clinmark participated in the opening of PolTREG S.A.'s state-of-the-art cell and gene therapy manufacturing facility in Europe.

Clinmark's team participated in the first clinical trials conference for medical devices in Poland.

Clinmark was nominated as a top 10 clinical trial management consulting company in Europe 2019.

Clinmark was recognized as one of the 10 most reliable CROs to watch in 2021 by Insightscare.

Clinmark was recognized as a top Polish brand and participated in the TOP POLISH BRANDS gala.

Clinmark was recognized as one of the top 10 medical device CROs in Europe in 2022.

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