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Medical device eCRF

Finally, clinical trials eCRF for medical device manufacturer

ECLEVAR MEDTECH is a global medical device CRO, headquartered in Paris. We support medical device manufacturer in the MDR and IVDR transition.

Why ECLEVAR MEDTECh eCRF?

Approach data capture with confidence

  • Store sensitive personal and research data within EU Certified Server 
  • Compliant with GDPR 
  • ISO27001 and ISO9001 compilant.

Implement and oversee your trial with ease

  • User-friendly platform for sites and investigators
  • Proactive support team to help ensure your study is successful

OUR HEALTHCARE DATA CAPTURE TEAM

Our team is led by former notified body and competent authority leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR.

OUR SERVICES:

At the end of a clinical trial, there is usually limited knowledge of the medium and long-term safety and performance of the device. The medium- and longer-term safety and performance of a device is estimated on the basis of premarket trial durations, that are generally inadequate to validate extrapolation hypothesis in real life, particularly implant longevity hypotheses. 

The aims of collecting RWE data as part of PMCF activities are: 

  • Study population that represents the entire population indicated in the IFU.  
  • Does not involve experimental exposure.  
  • Aiming to cover the “entire lifetime of the device 
  • Is conducted at all types of clinical site, not just specialist units  

ECLEVAR can help in collecting the clinical data required and provide long-term clinical strategy that support your business in EU, UK and Australia.

Benefits of Using an Electronic Data Capture System in Clinical Trials​

Collect scientifically valid and MDR compliant PMCF data using our platform:

Easy GDPR compliance.
Easily comply with GDPR requirements for informed consent and data protection. Our in house data protection officer monitor the compliance for all the studies

Pre-validated and compliant data platform: Our platform is compliant with ISO14155:2020 requirements and GDPR. 

Fully documented data traceability. All data inputs automatically include automatic user identification to ensure fully documented traceability from source to sponsor via using State of The Art technology Blockchain

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A management team with 20+ years experience and CRO expertise focused on medical devices and IVD​

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30+ years in Health Sciences providing industry leading and regulatory compliant technology to acquire, manage & analyze data​

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Unparalleled expertise to execute your trials with assured quality and to bring safe and innovative therapeutics to patients​

If you want know more, Get In touch with OUR Global Chief commercial OFFICER:

EDMUND WHITE

Within 3 years, ECLEVAR delivered transformative solutions.

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CASE STUDIES

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As shown by the Clinical Evaluation Report, intended claims on clinical safety and performance are not sufficiently supported with existing clinical evidence. In order to maintain “Vascular device “ in the European market, client has to conduct a PMCF study to generate sufficient clinical data in accordance with “Chapter VI – Clinical Evaluation and Clinical Investigations, specifically sections 62 – 82”. As well as ISO 14155:2020 

Objectives 

  • Confirming safety and performance of the Vascular device throughout its expected lifetime and both anatomic location: Carotid and femoral. 
  • Identifying and analyzing emergent risks on the basis of factual evidence, 
  • Ensuring the continued acceptability of the benefit- risk ratio referred to in EU MDR 
  • Identifying possible systematic misuse or off-label use of device X, with a view to verifying that the intended purpose is correct. 

Methodology  

A Sponsor conducted RWE multicentre study to collect clinical data for Vascular device. The objective was to examine short and long-term outcomes of using the device when exposed to a larger and more varied population. 

All data were retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery. 

300 subjects were evaluated from 3 different sites. 150 subjects were evaluated in carotid location and at least 150 in femoral location. 

Benefits 

  • Contribute to a larger body of evidence being developed: 
  • Representative population 
  • Accepted by the notified body for MDR certificate.  

Limitation: Incomplete long-term evidence.  

Solution: Implementation of European vascular registry  




TAP INTO THE ECLEVAR KNOWLEDGE CENTER

The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark.

In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD.

Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively.

OUR MEDICAL DEVICE PARTNERS AND ASSOCIATION