Our CRO services for Medical Devices

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.

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

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

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

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.

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 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 a 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).

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

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 timely manner to appropriate parties.

The clinical investigation is concluded with the writing of the clinical investigation report. This will be written based on the data collected in the clinical investigation and the statistical analysis report.

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.

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

PMCF data collection is important to understand the safety and performance of your device in “real-world” use. Prospective PMCF activities, such as a registry, follow the same process as a clinical investigation although not all requirements apply as the device already has market authorization.

Qserve also can support with PMCF surveys. In a high-quality PMCF survey, patient-specific clinical data are obtained based on a PMCF survey plan. In this plan, the following is covered:

• Clear scope
• Appropriate design including endpoints and acceptance criteria
• Evaluation of potential sources of bias, including measures to reduce bias as far as possible
• Statistical justification for the sample size
• Questionnaire covering at least the defined endpoints
• Methods for data collection and data analysis

The questionnaire in the survey will be completed by end-users based on the information documented in a patient chart.

With your input, Qserve will write the PMCF survey plan and design the questionnaire. After finalization of the plan, the questionnaire will be programmed in an electronic data capturing (EDC) system followed by deployment of the survey. The incoming completed surveys will be reviewed and managed. When all surveys have been collected, data will be analyzed, including statistical analysis to support that the endpoints of the survey are met, and a PMCF survey report will be written.

Services
Qserve provides the following services:

• Survey plan development
• Determine feasibility of survey execution
• Delivery of electronic survey
• Data management
• Data analysis and reporting
• Assistance with communication with Notified Body

As part of our medical device CRO services, we offer writing of clinical evaluations. In addition, the team is skilled for 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.

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