How we work

Qserve CRO strongly believes in the value of a dedicated and practical approach for your medical device clinical activities. Clinical data can be collected in very diverse ways and the method of data collection needs to suit your device classification, risk profile and product lifecycle. Qserve CRO is your experienced partner for pre-CE clinical investigations, PMCF studies, registries, retrospective data collection and surveys.

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 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.

Loes Pelgrim Qserve CRO

How we work

Qserve CRO strongly believes in the value of a dedicated and practical approach for your medical device clinical activities. Clinical data can be collected in very diverse ways and the method of data collection needs to suit your device classification, risk profile and product lifecycle. Qserve CRO is your experienced partner for pre-CE clinical investigations, PMCF studies, registries, retrospective data collection and surveys.

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 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.

Loes Pelgrim Qserve CRO

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.

FAQ

1. How much does a pre-CE clinical investigation cost?

This really depends on the size and complexity of your study. Key drivers of the overall costs are the number of sites, patients, assessments and time.

  • One site in Germany or 10 sites worldwide to be initiated, managed, monitored?
  • 20 patients or 200? All easy to enroll or a very specific, hard to find population?
  • One follow-up visit for each patient with a QoL questionnaire, or 10 monthly follow-ups including a CT-scan for each patient, each visit?
  • Running a study for 3 months or 3 years?
2. I do not know how to formulate a good endpoint?

Formulating an endpoint can be complex. Key aspect is to make sure the endpoint is measurable and clearly formulated. A good clinical evaluation is the starting point. After searching the literature, summarizing all data, putting together all tests and validation; which question is still unanswered? Can you formulate an endpoint that will answer that question?

3. What sample size do I need?

In any situation, pre- or post-marked the sample size needs to be calculated by a statistician. It needs to be justifiable why the number of patients is sufficient. The sample size depends on the certainty in performance and/or safety you are looking for, and the standard deviation of the population. At Qserve CRO we have statisticians available to support your statistical justification.

4. Do I need monitoring?

Monitoring is an important tool to assure quality compliance. The need for monitoring can be best determined case by case. Risk based. Within monitoring there are a lot of options differentiating from classic on-site source data verification (SDV) till remote monitoring with a risk-based frequency. 

5. How do I find sites to participate in my study?

Maybe you have a network of physicians or some key opinion leaders (KOL) that are willing to participate in your study. If not, or not sufficient we can qualify sites for you that fit your clinical activity. Maybe you are looking for a specific population, or you are still looking for that one, big, academic hospital to complete a differs group of sites. We have experience in how to approach and motivate sites and can rely on our network to bring your project up to speed

6. Would a survey be sufficient PMCF for my product that is in post-market phase?

Which type of clinical activity is suitable depends on the need. Again, we have to start with the clinical evaluation. What question needs to be answered? How big is the clinical data gap? Looking at all options; post-market study, registry, retrospective data collection, surveys, which method seems most suitable? Qserve CRO can help you consider, weighing the pros and cons.

7. Do you know a good EDC provider for my registry?

At Qserve CRO our monitors and CPMs work with multiple EDC providers on a daily basis. Selected by the study sponsor or based on our experience and suggestions. Therefore, we know the systems from the inside out. We work with preferred partners and can help you select the vendor that suits you best.  

8. Can Qserve CRO review my study protocol?

Yes, this is frequent request. Our review includes all aspects from clear endpoints, unambiguous language, till GCP (ISO14155) compliance.

9. I do not have budget for a study, are there other solutions?

Maybe there are other solutions. If you have a class III, pre-CE device we have to disappoint you. A clinical study is a regulatory requirement. But for lower risk devices and in post-market clinical follow-up (PMCF) together we can explore other, more economical options.

10. We do not have sufficient resources and experience in-house to run a study, what can we do?

Qserve CRO provides interim solutions, trainings, on-site or remote support. Please contact us and we can discuss your needs.

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