Medical Device CRO

Qserve, your full-scope CRO for Medical Device Clinical Trials

CRO

Full scope for Medical Device CRO

Clinical trials are a keystone during the development and life cycle of your medical device. Compliance with the Medical Device Directive, and in the near future the Medical Device Regulation, is vital to be able to obtain and/or maintain CE-marking.

Performing a clinical study is a serious and costly undertaking for every medical device manufacturer, requiring a strategic and practical approach.


 

 

Experience

Qserve CRO is a full medical device dedicated and experienced in all kinds of indications including urology, neurology, dental, cardiovascular, orthopaedics, ophthalmology, imaging, etc. We truly believe in a strategic, notified body proof and overall practical approach. Setting-up clinical trials tailored to your medical device-specific needs. Our clinical team gained experience working at Notified Bodies, CRO’s and Sponsors/Manufacturers. This combination of different backgrounds, combined with Qserve’s in-depth knowledge of regulatory affair creates efficient and compliant clinical trials. Our expertise includes feasibility, pre-CE and post-market studies from class I to class III.  

Because of our regulatory expertise, we are able to provide our practical approach, leading to very tailored trials. The advantage is that the design of the trial will be cost-effective.

Qserve has years of experience in regulatory affairs. Qserve CRO offers you the same, high level of expertise in clinical affairs. We support all kinds of trials for Class I Class III medical devices, to help you collect high quality, ISO14155, compliant clinical data. Our services include:

SUPPORT

We offer CRO support in the following areas

Clinical Strategy
Study design, global registration requirements, and sample size.

Clinical Study startup
Site feasibility/selection and essential documentation.

CA/EC submissions
Submission package and EC/CA/IRB/Hospital contact.

Medical Writing
Protocol, ICF, and an IB report.

ISO14155 & (GCP) Training
ISO14155, training, site initiation, and study-specific training.

Monitoring
CRAs, on-site (initiation, interim, close-out), remote, and risk-based.

Clinical Data Management
(e) CRF, EDC, safety monitoring, and statistical analysis.

Clinical Auditing
Site, CRO, contractor, sponsor, and pre-inspection.

Clinical Project Management
Full project management, investigator meetings, and interim Clinical Management.

How can we help you? Contact us