IYK
COSMOS Scientific
Accelerating Medical Device and Pharmaceutical Innovation from Concept to Market
About us
COSMOS Scientific is a Contract Research Organization (CRO) committed to advancing health through science, innovation, and collaboration. We specialize in conducting clinical trials for medical devices in Colombia and across other Latin American countries. In addition, we offer comprehensive Medical Affairs services to pharmaceutical companies worldwide.
Services
Our comprehensive range of services includes tailored solutions for medical device and pharmaceutical companies.
Clinical Trials for Medical Devices
At COSMOS Scientific we specialize in the design, management, and execution of clinical trials for medical devices across Colombia and Latin America. Our team ensures regulatory compliance, scientific rigor, and operational efficiency at every stage—from protocol development to site monitoring and data management—helping bring innovative technologies safely and effectively to market.
Medical Affairs
Our Medical Affairs services support pharmaceutical and medical device companies in building strong scientific and clinical foundations for their products. We offer expert medical writing, development of clinical practice guidelines, organization of advisory boards, and coordination of expert consensus initiatives. Our team bridges the gap between science, healthcare professionals, and regulatory requirements to ensure clarity, credibility, and clinical relevance in every project.
Training programs
At COSMOS Scientific, Inc., we offer specialized training programs designed to build capacity in key areas of healthcare innovation. Our courses cover the design and development of medical devices, entrepreneurship in healthcare, clinical research methods, clinical trial management, Good Clinical Practice (GCP), and technology transfer in medical devices. These programs are tailored for professionals, researchers, and innovators seeking to advance their skills and bring impactful health technologies to market.
Pharmacovigilance
We provide specialized pharmacovigilance services designed to meet the regulatory requirements and public health priorities of Latin America. Our team supports pharmaceutical companies, CROs, and healthcare organizations in implementing robust safety monitoring systems that ensure patient protection and regulatory compliance across the region.
Our services include:
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Collection, assessment, and reporting of adverse drug reactions (ADRs)
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Local literature surveillance and health authority reporting
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Management of serious and unexpected adverse events (SUSARs) in clinical trials
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Preparation of Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs)
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Signal detection and benefit-risk evaluations
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Support for regulatory inspections and local QPPV representation
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Compliance with national regulations (INVIMA, ANVISA, COFEPRIS, DIGEMID, ISP, etc.)
We operate in alignment with international standards (ICH, WHO, EMA, FDA) and adapt to the specific pharmacovigilance frameworks of each Latin American country, helping our clients stay compliant while prioritizing patient safety.
Clients
Client Satisfaction
