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DirectoryBusiness & Technical ServicesResearch & DevelopmentChamRede Optimus Hospitalar AG
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Rede Optimus Hospitalar AG

Summary

About the company

Rede Optimus is a Contract Research Organization (CRO) specializing in clinical trials and research in the field of medicine. The company's core activities include: conducting clinical trials for the medical industry, regulatory affairs and reimbursement support, medical writing and publication of study results, post-marketing clinical follow-up (PMCF) studies, investigator-initiated research and collaborative research with industry, and support for the approval of medical devices and obtaining CE markings and FDA approvals. The company also offers services such as electronic data capture (EDC), programming, and case report forms (CRFs), and has a network of highly qualified medical centers and experienced medical professionals.

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Clinical studies for medical devices
Clinical studies with medical devices to address open medical questions, including industry-sponsored research, investigator-initiated research and collaborative research.
CRO services
Full range of CRO services for industry-sponsored research with medical devices, including study coordination, site selection, EDC, programming and Case Report Forms.
Regulatory affairs and reimbursement support
Support for regulatory affairs and reimbursement matters, including submissions to EC/IRB and authorities as well as support for CE and FDA approvals.
Medical writing
Medical writing for study protocols and study-related documentation, prepared by experienced cardiovascular surgeons and compliant with relevant standards.
Post-marketing clinical follow-up (PMCF) studies
Post-marketing clinical follow-up studies to collect MDR-relevant data for CE-marked medical devices and to support market access and reimbursement.

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Location

Alte Steinhauserstrasse 1
6330 Cham

At a glance

Legal form
Corporation
UID
CHE-216.455.548
Founded
2016 · 10 years
Last commercial register change
July 8, 2022
Employees
11 to 20

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