What we do

Together, 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 ISO9001 and ISO14155 compliant QMS. We ensure GCP (ISO14155) compliance in a practical way.

“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 affairs creates efficient and compliant clinical trials. “
Jorn van Binsbergen / Clinical Writer
Jorn van Binsbergen

Qserve’s team has extensive awareness of medical writing, data analysis and broad experience as writers of CEP’s and CERs, we can support any medical  device manufacturer. Contact us and our team will answer all your questions about our services, solutions and budgets.

Contact us
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 consider the feasibility of operational plans on budget, timelines, and marketing requirements.

A professional clinical strategy meets the following requirements:

Identification of specific regulatory requirements to be addressed

Evaluation of suitable countries to run your clinical activities

Evaluation of suitable sites / health care professionals to involve

Connecting risk management activities to your protocol

Identification of project risks

Evaluation of clinical claims and how your clinical protocol can be supportive

Verify the need to collect additional/other clinical data. Endpoint formulation

QServe-CRO-Planning

Study Start-Up

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

Study Management

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

Analysis and Reporting

After completing the clinical investigation, data will be cleaned, locked, analyzed and reported in a clinical investigation report. Depending on the design, the endpoints and the follow-up timelines for the clinical investigation, also an interim report can be written.

QServe-CRO-Clinical Strategy

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

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:

Identification of specific regulatory requirements to be addressed

Evaluation of suitable countries to run your clinical activities

Evaluation of suitable sites / health care professionals to involve

Connecting risk management activities to your protocol

Identification of project risks

Evaluation of clinical claims and how your clinical protocol can be supportive

Verify the need to collect additional/other clinical data. Endpoint formulation

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

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:

Fixed price EUR 2450 (per product)

Share your product CER, PMCF plan and related PMCF activity documentation

Qserve CRO clinical consultant reviews and provides valuable comments

Review includes: suggestions for improvements, sharing experience we gained, regulatory and clinical compliance to MDR and other relevant standards (MDCG/ISO/…etc.)

Read more