How we work

Are you looking for a partner for medical device clinical services? Qserve CRO is specializes in medical device clinical trials, clinical evaluation and PMCF surveys.  Our clinical, regulatory, and quality experts work collaboratively with your team to design and conduct medical device clinical trials ensuring quality and compliance with a focus on the European market.

Qserve dedicated clinical and regulatory team will help guide you in selecting the optimal regulatory pathway to success. Made up of the CRO, the medical writing team and medical device consultancy team, our experts specialize in pre-CE investigations/trials, clinical writing, clinical evaluations (CEP/CER), registries, retrospective data collection, and PMCF surveys. Using experience of former Notified Bodies reviewers and regulatory experts, the team is quipped to perform efficient medical device clinical trials, while fostering relationships with the clinical trial sites to ensure key milestones are achieved.

Qserve CRO uses a practical approach when executing medical device clinical trial activities guaranteeing the project is delivered as planned – high-quality, on time and within budget. The team’s strong regulatory, clinical, and quality knowledge is used to further support customers in developing strategies for efficient and compliant clinical trials and clinical evaluations.  

Armel Plaine
“We are a full-service medical device dedicated CRO, therefore we know the regulatory requirement of this industry and the struggles of medical device manufacturers to obtain and maintain CE-marking under MDR.”
Armêl Plaine / Sr. Clinical Project Manager

Do you want to learn more about how our regulatory and clinical expertise can benefit your medical device study?
Contact us and our team will answer your questions about our services and agree on the perfect project plan.  

Contact us

As your clinical service partner, our experienced team of clinical project managers, clinical research associates, clinical trial assistants, statisticians, and data managers will:

  • Work on a clinical/regulatory compliant strategy for your medical device
  • Develop a strategic planning and budget overview
  • Begin the process of creating essential documents and maintain your trial master file
  • Help select and/or communicate with study sites throughout Europe
  • Ensure your study is fully ISO 14155 compliant
  • Educate and train staff on Good Clinical Practice (GCP)
  • Support statistical analysis and data management
  • Provide guidance with your Electronic Data Capture system (EDC)
  • Manage study progress and perform site management
  • Ensure the clinical study is completed in a compliant manner
  • Analyze the data and write a clinical investigation report

== As ethics, scientific validation, and compliance are essential, we always ensure GCP (ISO14155) compliance is supported by our ISO9001 and ISO14155 compliant QMS.

Qserve CRO, the full service, medical device dedicated CRO

Clinical Evaluation

To be able to initiate an activity of clinical data collection, the clinical evaluation needs to be in place. A good clinical evaluation clarifies where clinical data gaps do exist and what further data are required to be obtained for your device. Together we can formulate the questions that need to be answered to reach full conformity for your device.

Clinical strategy

The clinical questions that originate from the clinical evaluation feed into a more detailed clinical strategy. Parts of a clinical strategy involve; selecting the patient population, device regulatory status, long-term strategies, formulating endpoint and statistical justification. This phase of strategy development includes scoping and decision making. Qserve CRO is your experienced partner, guiding you through this challenging process.  

Project Planning

Based on a well-developed clinical strategy, the operational part can be initiated. Planning involves the set-up of essential documents, allocation of resources and selection of partners.  Essential documents include; a study protocol (CIP), informed consent form (ICF), case report forms (CRFs). Partners to be selected include; an electronic data capture (EDC) system provider, study sites and monitors. Submission to an ethics committee (EC) or independent review board (IRB) for approval is mandatory. In some cases, the competent authority needs to be notified as well. At Qserve CRO we have an internal team of experienced clinical research associates (CRAs) and clinical project managers (CPMs) to perform these tasks for you, or support your internal team where necessary.

Study Conduct

Operational excellence is in our DNA. In the phase of conducting your clinical activities the study sites will be initiated, first patients will be enrolled and clinical data is collected. Qserve CRO will help you manage progress, sites and monitors in compliance with GCP (ISO14155).

Clinical data

At Qserve CRO we have data managers and statisticians that will analyse the clinical data points collected and provide you the results. Developing the clinical investigation report (CIR) that captures the outcomes is the final steps in completing your clinical activities.

Clinical evaluation Report

The output of your clinical activities feeds into your clinical evaluation, closing the clinical gaps. A final clinical evaluation report (CER) based on sufficient clinical evidence completes your technical documentation. Initial CE-mark, or confirmed performance and safety of products in post-market phase, own clinical data safeguards your CE-mark.

At Qserve CRO we are pleased to be your experienced and dedicated, clinical partner.

QServe-phase-clinical data

Qserve CRO, the full service, medical device dedicated CRO

QServe-phase-clinical data

Clinical Evaluation

To be able to initiate an activity of clinical data collection, the clinical evaluation needs to be in place. A good clinical evaluation clarifies where clinical data gaps do exist and what further data are required to be obtained for your device. Together we can formulate the questions that need to be answered to reach full conformity for your device.

Clinical strategy

The clinical questions that originate from the clinical evaluation feed into a more detailed clinical strategy. Parts of a clinical strategy involve; selecting the patient population, device regulatory status, long-term strategies, formulating endpoint and statistical justification. This phase of strategy development includes scoping and decision making. Qserve CRO is your experienced partner, guiding you through this challenging process.  

Planning

Based on a well-developed clinical strategy, the operational part can be initiated. Planning involves the set-up of essential documents, allocation of resources and selection of partners.  Essential documents include; a study protocol (CIP), informed consent form (ICF), case report forms (CRFs). Partners to be selected include; an electronic data capture (EDC) system provider, study sites and monitors. Submission to an ethics committee (EC) or independent review board (IRB) for approval is mandatory. In some cases, the competent authority needs to be notified as well. At Qserve CRO we have an internal team of experienced clinical research associates (CRAs) and clinical project managers (CPMs) to perform these tasks for you, or support your internal team where necessary.

Conduct

Operational excellence is in our DNA. In the phase of conducting your clinical activities the study sites will be initiated, first patients will be enrolled and clinical data is collected. Qserve CRO will help you manage progress, sites and monitors in compliance with GCP (ISO14155).

Clinical data

At Qserve CRO we have data managers and statisticians that will analyse the clinical data points collected and provide you the results. Developing the clinical investigation report (CIR) that captures the outcomes is the final steps in completing your clinical activities.

Clinical evaluation Report

The output of your clinical activities feeds into your clinical evaluation, closing the clinical gaps. A final clinical evaluation report (CER) based on sufficient clinical evidence completes your technical documentation. Initial CE-mark, or confirmed performance and safety of products in post-market phase, own clinical data safeguards your CE-mark.

At Qserve CRO we are pleased to be your experienced and dedicated, clinical partner.

Our services

QServe-CRO-Clinical Strategy

Clinical Strategy

  • Clinical/ regulatory strategy
  • Endpoints
  • Geographic focus
  • Feasibility
  • Clinical development plans
QServe-CRO-planning

Planning

  • Essential documents development (CIP/ICF/CRF/IB)
  • Study site qualification and selection
  • EDC Selection
  • CA submission/ notification
  • EC submission
  • Clinical Investigation support (Pre-CE)
  • PMCF activity support (Post-market)
  • Statistics
  • Data analysis plan
QServe-CRO-conduct

Conduct

  • Site initiation
  • Monitoring
  • Site management
  • Recruitment
  • Safety reporting
  • Project Management
  • Data Management
  • Document management
QServe-CRO-close-out

Other services

  • Audits
  • Interim solutions
  • Remediation of ongoing studies
  • Medical writing
  • Consultation