Qserve CRO’s Commitment to Excellence in Action

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 plan and budget overview
  • Ensure your study is fully ISO 14155 and MDR compliant
  • Support the preparation or review of your clinical trial protocol
  • Gen…nic Data Capture System (EDC)
  • Help select and/or communicate with study sites throughout Europe
  • Educate and train staff on Good Clinical Practice (GCP)
  • Conduct monitoring visits including site initiation visit and close-out visit
  • Support data management
  • Manage study progress and site management
  • Support with safety reporting
  • When applicable support and arrange a DSMB/CEC committee
  • Ensure the clinical study is completed in a timely and compliant manner
  • Analyze the data and write your 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

Qserve 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.


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.


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 CRO

Qserve CRO specializes in:

Qserve CRO

Clinical Strategy

  • Clinical/regulatory strategy
  • Endpoints
  • Geographic focus
  • Feasibility
  • Clinical development plans
Qserve CRO


  • 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


  • Site initiation
  • Monitoring
  • Site management
  • Recruitment
  • Safety reporting
  • Project management
  • Data management
  • Document management
Qserve CRO

Other services