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

Qserve has years of experience in regulatory affairs. Qserve CRO offers you the same, high level of expertise in clinical affairs. We can support all kinds of activities that will help you collect high quality, ISO14155 and regulatory compliant clinical data. Our services includes Clinical Strategy, Study start upMonitoring, Data Management, Auditing, Training, Medical Writing, regulatory submissionsProject Management.

We truly believe in a strategic, notified body proof and overall practical approach. Setting-up clinical trials tailored to your medical device specific needs.

Experience

Qserve CRO is fully medical device dedicated and aims to be as lean as possible, avoiding unnecessary administration and bureaucracy. Our clinical team gained experience working at: Notified Bodies, CRO’s and Sponsors/Manufacturers. This combination of different backgrounds, combined with Qserve’s indepth knowledge of regulatory affairs will help you design and execute an efficient and notified body proof study. Our expertise includes feasibility, pre-CE and post-market studies from class IIa/b to class III.  

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

 

We offer support in the following areas

Clinical Strategy
study design, global registration requirements, sample size 

 

Clinical Study start up
site selection,essential documentation

CA/EC submissions
submission package, EC/CA/IRB/Hospital contact

Medical Writing
protocol,ICF, IB writing review

Site Selection & (GCP) Training
ISO14155, study specific training

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

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


Clinical Auditing
site,CRO, contractor, sponsor, pre-inspection

 

Clinical Project Management
full project, investigator meetings, interim clinical affairs management

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