Our services

We work together with you to develop the clinical studies and post-market clinical follow-up (PMCF) activities that fit your specific needs. As a medical device dedicated CRO, we know the regulatory requirements and the struggles of medical device manufacturers. We provide practical solutions, fit to budget, especially in areas where there is limited guidance from the regulator. We always ensure GCP (ISO14155) compliance in a practical way.

Sufficient clinical evidence is required to obtain – and keep – market approval for your medical device. Our goal is to help you obtain the quality and amount of data that is needed to satisfy the regulatory requirements.

Iris Verboven Qserve CRO

Our services

We work together with you to develop the clinical studies and post-market clinical follow-up (PMCF) activities that fit your specific needs. As a medical device dedicated CRO, we know the regulatory requirements and the struggles of medical device manufacturers. We provide practical solutions, fit to budget, especially in areas where there is limited guidance from the regulator. We always ensure GCP (ISO14155) compliance in a practical way.

Sufficient clinical evidence is required to obtain – and keep – market approval for your medical device. Our goal is to help you obtain the quality and amount of data that is needed to satisfy the regulatory requirements.

Daan Pelgrom-CRO-Qserve
QServe-CRO-Clinical Strategy

Clinical Strategy

A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence.  The Clinical Evaluation is a critical element in the CE marking pathway for a new medical device on the European market.

We will always take into account the feasibility of operational plans on budget, timelines, and marketing requirements.

A professional clinical strategy meets the following requirements:

QServe-CRO-Clinical Strategy

Clinical Strategy

A good clinical strategy gives you a competitive advantage, by bringing your device to market faster and supporting unique claims with solid clinical evidence.  The Clinical Evaluation is a critical element in the CE marking pathway for a new medical device on the European market.

We will always take into account the feasibility of operational plans on budget, timelines, and marketing requirements.

A professional clinical strategy meets the following requirements:

QServe-CRO-Planning

Planning

Study start-up is a dynamic phase in which it is important to manage cost and quality while keeping the time to site activation as short as possible. Qserve will manage the various elements on the path to site activation in parallel and go the extra mile to get your study started as soon as possible. Having country and site intelligence we can advise accurately on expected costs and timelines.

QServe-CRO-Planning

Planning

Study start-up is a dynamic phase in which it is important to manage cost and quality while keeping the time to site activation as short as possible. Qserve will manage the various elements on the path to site activation in parallel and go the extra mile to get your study started as soon as possible. Having country and site intelligence we can advise accurately on expected costs and timelines.

QServe-CRO-Conduct

Conduct

A clinical investigation requires a dedicated team for the management of resources, documents, and overall study progress. The amount of time necessary for adequate study management, and the influence it can have on costs, timelines, and data quality is often underestimated. Medical device clinical trial management requires project oversight, experience in medical device clinical investigations, operational management, effective communication with sites and monitors.  A hands-on approach.

QServe-CRO-Conduct

Conduct

A clinical investigation requires a dedicated team for the management of resources, documents, and overall study progress. The amount of time necessary for adequate study management, and the influence it can have on costs, timelines, and data quality is often underestimated. Medical device clinical trial management requires project oversight, experience in medical device clinical investigations, operational management, effective communication with sites and monitors.  A hands-on approach.

QServe-CRO-ClouseOut

Other services

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 backgrounds, combined with Qserve’s in-depth knowledge of clinical and regulatory affairs will offer you a comprehensive, objective, and compliant solution.

QServe-CRO-ClouseOut

Other services

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 backgrounds, combined with Qserve’s in-depth knowledge of clinical and regulatory affairs will offer you a comprehensive, objective, and compliant solution.