Our services

Together with you we develop a clear strategy, planning and cost proposal for the clinical study or post-market clinical follow-up (PMCF) activity you would like to outsource to our team. . Our team is fully ISO14155 trained and we work in accordance with an ISO9001 and ISO14155 compliant QMS. We ensure GCP (ISO14155) compliance in a practical way.

Rachel Derksen

Our services

Together with you we develop a clear strategy, planning and cost proposal for the clinical study or post-market clinical follow-up (PMCF) activity you would like to outsource to our team. . Our team is fully ISO14155 trained and we work in accordance with an ISO9001 and ISO14155 compliant QMS. We ensure GCP (ISO14155) compliance in a practical way.

Rachel Derksen
QServe-CRO-Clinical Strategy

New: 360° PMCF Strategy Review

Qserve CRO reviews your PMCF strategy and provides suggestions for improvement, shares experience, and reviews for regulatory and clinical compliance.

Conditions:

Read more
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-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-Clinical Strategy

New: 360 degrees PMCF Strategy Review

Qserve CRO reviews your PMCF strategy and provides suggestions for improvement, shares experience, and reviews for regulatory and clinical compliance.

Conditions:

Read more
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-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.