Medical Devices

Clinical Research for Medical Devices

Pharmaxi is a full-service contract research organization (CRO) that specializes in organizing and conducting clinical trials for medical devices and medical-grade software.

These trials are essential for devices specifically designed for medical applications. They may also include consumer-grade devices with potential medical applications, such as diagnostic or therapeutic components. Additionally, the scope extends to software solutions capable of interpreting data from wearable devices, sensors, and measurement tools.

Our Expertise

Pharmaxi conducts clinical research on medical devices with a confirmed safety profile. To evaluate the efficacy of medical devices, obtaining regulatory approval from governing bodies and local ethical committees is mandatory.

As a trusted medical device clinical research organization, we handle all aspects of clinical trial preparation and management, including:

• Developing core documentation (Protocol, Informed Consent Form, Case Report Form).

• Collecting and compiling required documents from the manufacturer.

• Securing approval for the clinical trial in Poland and Ukraine.

Comprehensive Services Offered

As a leading medical device CRO company, Pharmaxi provides the following services:

1. Project Design.
   Tailored study designs aligned with your objectives and expectations.
2. Document Preparation.
   Development of essential documentation, including protocols, CRFs, and informed consent forms.
3. Regulatory Approval.
   Obtaining authorization from regulatory bodies and ethical committees.
4. Feasibility and Site Selection.
   Identification and evaluation of medical centers suitable for the study.
5. Data Collection and Analysis.
   We use validated Electronic Data Collection systems to collect reliable clinical data in the most efficient way. Planning, execution, and monitoring of data gathering procedures, followed by statistical analysis.
6. Reporting.
   Preparation of a comprehensive statistical report and final study documentation.
7. Archiving.
   Systematic archiving of trial data for future reference.
8. Vendor Management.
   Contract negotiation and oversight of third-party providers (insurance, logistics, customs).

Specialized Support

As a trusted device CRO, Pharmaxi offers expertise in handling the unique challenges of medtech clinical trials. From regulatory compliance to logistics, we ensure every phase of your trial runs smoothly.

Have questions about planning or conducting clinical trials for medical devices? Contact us at +38 067 548-01-69 or fill out the contact form on our website. Additionally, we offer a free 30-minute consultation to address any inquiries related to clinical research for medical devices.

Pharmaxi: Your partner in clinical research for medical devices and medtech innovation.

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