Clinical Research

Development for medical technologies can be challenging without the right people, processes, evidence and insights

Clinical studies are the essential step in ensuring your product is safe and effective, and that it fulfills its intended use.
Fervor offers clinical solutions for today’s dynamic medical device and diagnostics industry.

Combined with experience and expertise for providing best quality and cost effective time bound solutions, we ensure you stay on time and on budget for your pre-market to post-market product lifecycle.

What can we offer?

With decades of experience conducting medical device clinical studies to European requirements. We offer a turnkey CRO solution and manage end to end post-market medical device clinical studies.

Fervor global clinical experts:

Bespeak Proof of Principle or First in Man (FIM) studies.
Demonstrate Clinical safety and performance /effectiveness for CE Marking.
Procure post-market clinical evidence data with CE Marking.
Conduct HEOR and derive to generate scientific evidences.
Generates clinical evidence for marketing claims

Right from preparation of your clinical study strategy to completion of study report, we manage every aspect in compliance with all applicable quality aspects. Integrity is the key for our deliverables.

Medical Device Clinical Trial Inception and Management

How we do:

Project management
Study start up activities including Investigator and site selection/recruitment
Clinical Writing including Study design input/review - optimization of endpoints
Vendor identification, control and management (e.g., central lab etc.)
Clinical Study insurance support
Competent Authority and Ethics Committee submission and liaison.
Regulatory Compliance management
Study monitoring
Data management services
Clinical writing (Protocol, CSR, CER, study related documents and tools etc.)
Trial Master File maintenance
Quality Control

Overseeing progress of the clinical trial to ensure the study protocol is being followed and compliance with GCP and ISO 14155 is being implemented.
Reviewing documents to verify that reports, submissions, and other documents are accurate and up to date.
Monitoring of adherence to the clinical investigation plan and ensuring consistency of data collection and patient treatment across multiple sites.
Ensuring that adverse events are reported in accordance with GCP, the protocol, independent Ethics Committees, and any regulatory mandates.

Our project management and monitoring services include, but are not limited to:

Our team expertise covers a wide range of devices and study types, including but not limited to FIM studies, prospective CE Marking RCT (blinded or not), and Post-Marketing Clinical Follow Up (PMCF) studies. Under the MDR, the latter will be mandatory in an ever-wider scope of products, with similar initiatives emerging in the US (Real Life Data) and Japan