Our Mission

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.
Graph Collaborative Research
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
• Flexibility
• 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

Our
Services

Graph
Plus
Helping investigators organizing their study ideas, from A to Z.
Gear
Full range of CRO services for industry-initiated research.
Money
Regulatory Affairs & Reimbursement support:
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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

Imprint

    Legal Notice:
    This website contains offers and information of Rede Optimus.

Contact

    You feel interested? You want more information? You have a study idea? You want to join as a clinical center?
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