Rede optimus was founded by interventional cardiovascular and peripheral surgeons to conduct highly relevant clinical trials with medical devices to address the unanswered questions in medicine.
To that end, Rede Optimus will focus on trials to identify the best way to treat patients, targeting to improve or expand existing therapies, separating responders from non-responders and eventually developing new reimbursement models. A network of high-quality medical centers, led by innovative and leading specialists is ensuring the adequate volume and scientific rigour needed for relevant clinical studies.
In a challenging landscape with new technologies, doctors, hospitals and changing health reimbursement systems, we want to define best treatment therapies for each indication. Our goal is finding the best possible treatment for our patients.
What do we offer?
• Full range of CRO services for industry initiated research for all medical devices
• Investigator Initiated Research
• Collaborative Research with industry
• Regulatory Affairs and Reimbursement support
• Medical writing
• Post-Marketing Clinical Follow-up (PMCF) studies
Why work with us?
• Large network of high-volume scientific centers
• Milestone payments
• Proven track records
> 85 years of experience in clinical research
> 140 clinical studies conducted
> 20 countries involved in clinical studies
• Facilitation of presentation / publication of the study results
Helping investigators organizing their study ideas, from A to Z.
Full range of CRO services for industry-initiated research.
Regulatory Affairs & Reimbursement support:
Post-Marketing Clinical Follow-ups (PMCF) studies
Expert medical advisors
Select the right sites with both therapeutic expertise, ensuing enrollment success
Electronic Data Capture (EDC), Programming, and Case Report Forms (CRFs) geared to meeting ISO 14155 & Medical Device Requirements
Submission to EC/IRB and CA/FDA
Ensuing transparent, clear communication, and on-time & on-budget
Expert medical writing by experience cardiovascular surgeons compliant with CFR 812, ISO 12155 & MedDev 2.7/1 Rev 4
Protocol creation with expert medical expertise
Core lab services
Gathering MDR required PMCF data on CE marked devices
Guiding companies in obtaining CE approval and supporting them in obtain CE mark/FDA approval or reimbursement on their device
This website contains offers and information of Rede Optimus.
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