Qserve is a medical device dedicated, ISO 14155 compliant, full service contract research organization (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.
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 Clinical Strategy, Study start up, Monitoring, Data Management, Auditing, Training, Medical Writing, EC/CA/IRB communication, Project 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.
Qserve CRO is a fully medical device dedicated and experienced in all kinds of indications including urology, neurology, dental, cardiovascular, orthopedics, ophthalmology, imaging, etc. 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.
"For several years, I worked as a Monitor/Clinical research associate (CRA) for both manufacturers and CROs. Practical implementation of protocols is often a hurdle, leading in worst cases to delays, slow enrollment or low-responsive sites. My everyday goal at Qserve is to bring the clinical trials of our customers to life. In the end, it is all about people who deliver and support science based, quality medical care."
study design, global registration requirements, sample size
Clinical Study start up
site feasibility/selection,essential documentation
submission package, EC/CA/IRB/Hospital contact
protocol, ICF, IB report
ISO14155 & (GCP) Training
ISO14155, training, site initiation, study specific training
CRAs, on-site (initiation, interim, close-out), remote, risk-based
Clinical Data Management
(e) CRF, EDC, safety monitoring, statistical analysis
site,CRO, contractor, sponsor, pre-inspection
Clinical Project Management
full project management, investigator meetings, interim clinical management
This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD, and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.