Our services

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.

Jasmin
“Qserve CRO has experts who are very familiar with identifying the correct regulatory requirements to be addressed, as well as developing an appropriate research question(s) required to fulfill the regulatory requirements.”
Jasmin Hunter / Clinical Evaluation Expert

Qserve’s team has extensive awareness of medical writing, data analysis, and broad experience as writers of CEPs 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.

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Clinical Investigation Design

Based on your clinical strategy, Qserve CRO can help you to determine the most appropriate clinical study design as a key element for a successful clinical investigation. This includes amongst others definition of endpoints, statistical sample size calculations, and patient follow-up requirements. We have experience with pilot studies, pivotal studies, and post-market studies.   

Qserve clinical studies can be designed in compliance with ISO 14155, EU MDR, applicable FDA regulatory requirements and guidance documents, MDCG guidance documents, and as required, customized to local and national regulations.  

Clinical Project Management

For a clinical investigation, dedicated project management is important to manage resources, documents, and overall study progress. The amount of time required for the management of a clinical study is often underestimated. Our customized clinical project management approach ensures adherence to the plans combined with good quality. In addition, it focuses on the minimization of any project risks. Lastly, adequate and tailored Clinical Project Management will result in a positive return on investment.

Expertise
Qserve’s experts are experienced in managing clinical investigations with medical devices from start to end. We know where to expect the pitfalls and how to keep all stakeholders on track. Our multi-national team has extensive experience in clinical affairs, study management, and project management, developing and maintaining monitor and site relations.

Clinical Project Management includes:

  • Development and management of site relationships
  • Resource management
  • Team coordination
  • Problem-solving
  • Quality and regulatory compliance
  • Progress and deadline compliance

Site Feasibility assessment, Site Selection, and Site Qualification

Country and site feasibility assessment is the foremost element in a successful clinical investigation. Proper site feasibility assessment and site selection ensure completion of the milestones and inclusion of subjects with the planned enrollment rate.

Our team can support you with:

  • Site feasibility assessment
  • Site selection
  • Site qualification
  • Plan the enrollment rate and anticipations related to the clinical investigation
  • Manage local challenges
  • CIP assessment to reduce site-specific risks

Regulatory submissions (Ethics Committees/ Competent Authorities)

Qserve CRO can support you with Ethics Committee (EC)/Institutional Review Board (IRB) and Competent Authority (CA) submission and obtaining approval for your medical device clinical investigations. Although ISO 14155 prescribes generally the sponsor’s obligations in communicating with CA and EC, there are significant differences between countries and even within countries. National laws and regulations influence the submission and reporting requirements and timelines. Our regulatory experts are continuously following the changes in all local legislation, guidelines and regulations to ensure a short as possible EC and CA review timelines.

Differences between countries in CA and EC/IRB requirements can impact study budget and planning, and choice of local study sites and should preferably be part of your clinical strategy. With our experience, we can assist in an efficient Regulatory Submission process including submission, (re-)approval, maintenance, and reporting.

Qserve can support you with:  

  • Submission planning and strategy
  • Compiling submission packages
  • Ethics Committee (EC)/IRB submission
  • Competent Authority (CA) submission
  • Local hospital board submission
  • Amendments and study termination submissions

Data management

The aim of data management is to provide high-quality data and gather the maximum amount of valuable data for analysis. In this process, data are collected, cleaned, and managed. High-quality data should be attributable, legible, contemporaneous, original and accurate (ALCOA). High-quality statistically valid data are important for the outcome of the study and can give you a head start on the competition. 

EDC Systems

Generally, electronics data capturing systems (EDCs) are used where investigators can directly upload the data in electronic case report forms (eCRFs). At the end of the clinical trial, the data set in the system is provided to statisticians for further analysis. An appropriate statistical analysis should reveal if differences in effects between two or more interventions are significant or due to chance. Data analysis must be tailored to your research questions and defined before data collection starts.

Expertise

Qserve CRO team has experienced Clinical Data managers. The data managers have experience with several data management systems and work with professional, validated electronic data capture (EDC) systems. Thereby, we can ensure the reliability of your study data and construct a compliant database for final analysis. We are also flexible and can utilize our client preferred platforms. Our team can assist with all, or part of the Data Management activities.

Biostatistics

Biostatistics are used for a statistically sound design of the clinical investigation. Based on the design of the clinical study, a statistical analysis plan is developed. After completion of the study, a statistical analysis report will be made that provides all statistical analysis performed for the study.

Our services for Biostatistics:

  • Design of the clinical investigation
  • Sample size calculation
  • Statistical analysis planning
  • Statistical analysis report

Monitoring

Monitoring of clinical study sites ensures that your clinical study is conducted in compliance with Good Clinical Practice (GCP) and ISO 14155. Qserve has experienced clinical research associates (CRAs) within their team and abroad worldwide network of monitors. Our CRA team (internal or outsourced) is strategically located geographically to cover a broad range of site locations.  

When you delegate your monitoring activities to Qserve, we will create a tailored monitoring plan and allocates dedicated monitors/CRAs to your study and site(s). This will establish a good site relationship and the CRA serve as the site’s primary point of contact. The monitor’s in-depth knowledge of the protocol, ICF, CRFs, and operational and procedural plans results in efficient and compliant monitoring. Qserve supports site selection and initiation, interim monitoring, close-out visits, (re-)training of sites, file reviews, query resolution and support of follow-up actions. Our monitors are comfortable with remote monitoring and risk-based monitoring, as well as 100% on-site source data verification (SDV).

Training

We offer a comprehensive program of training courses on a wide range of clinical topics. Our courses are delivered by our experts and are suitable for professionals at all stages of their career

Our training courses:

  • Clinical Evaluation under the MDR
  • Literature Search for Medical Device Design
  • Literature Search for IVDs
  • PMCF
  • Clinical Surveys
  • ISO 14155 GCP

CEC and DMC activities

The data monitoring committee (DMC, also called DSMB) is established by the sponsor. The DMC monitors progress of the clinical study and reviews safety and performance data to advise the sponsor on continuing, suspending , modifying or stopping the clinical data. A Clinical Events Committee (CEC) is a committee of independent experts that takes decisions on safety and performance endpoints. The ultimate goal of the CEC is to have a high-quality standardized outcome for relevant endpoints.

We are able to:

  • Develop DMC and CEC charters
  • Create documentation for DMC and CEC review
  • Support in scheduling/organizing DMC and CEC meetings

Safety Reporting

Qserve team manages and coordinates safety reporting according to applicable regulations such as Medical Devices Regulation (EU) 2017/745 (MDR), FDA regulatory requirements, and MDCG guidance (2020-10/1) together with local/country-specific regulations. Adverse events are reported in a reasonably timely manner to appropriate parties.

Clinical Investigation Documentation

Clinical investigation documentation, including but not limited to Clinical Investigation Plan (CIP), Investigator Brochure (IB), Informed Consent Form (ICF), and Clinical Investigation Report(s) can be written In accordance with Good Documentation Practice, ISO 14155 requirements and applicable local requirements by Qserve. We have experience with the development of all the essential documents for clinical investigation on behalf of manufacturers. Medical writing will be involved in creating and reviewing the essential documents as medical writing is an art and a skill. As part of our medical device CRO services, we offer medical writing of other clinical documentation, such as scientific publications, investigator newsletters, promotional materials or training slide decks. In addition, Qserve can support with writing of technical documentation to support clinical investigations. We always ensure regulatory compliance.

In addition, we can prepare, manage and maintain the Trial Master File (TMF) during clinical investigations ensuring compliance to ICH-GCP and ISO 14155.

Clinical Auditing

Clinical Auditing according to ISO 14155
Collaborations and delegation of tasks among several stakeholders is common in clinical studies. However, as a sponsor you have the obligation to keep oversight, and to take responsibility for regulatory compliance, ethical conduct and the quality and integrity of your clinical data. Auditing is a valuable tool to evaluate compliance with the protocol, the procedures, International Standards and the applicable regulatory requirements.

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 audit.

Auditing your vendors, external- and/or internal processes by Qserve auditors gives an independent and systematic overview of the study compliance and the data quality. We provide clear and concise audit reports and can help write and implement corrective and preventive actions (CAPAs) when needed.

Qserve can perform all types of audits tailored to your expectations. Among others we offer:

  • Study site audit
  • Sponsor internal audit
  • CRO audit
  • Subcontractor audit
  • Trial master file audit
  • Inspection readiness audit