We provide you with full support in determining the clinical performance of your IVD product, from determining gaps in the available clinical evidence to study planning, execution and evaluation.
Our Consulting Services at a Glance
Strategic Planning for Your Market Goals
In an interactive process, we help you lay the groundwork for a successful market entry. We identify main regulatory requirements, define and roadmap study and submission milestones, and outline the associated costs, efforts and timelines, ensuring an efficient and streamlined path for your IVD to reach international target markets.
Streamlining of Clinical Performance Evaluation
In collaboration with our scientific affairs team, we evaluate available performance data, peer-reviewed literature and data gained by routine diagnostic testing to determine whether the available clinical evidence is sufficient or whether a clinical performance study or PMPF is necessary. We consider optimal sources for samples and associated clinical data, whether from commercially available biobanks, left-over samples from previously conducted clinical studies or prospective patient enrollment.
Study Design
We support you through the study design process to generate compliant, sufficient clinical evidence tailored to your IVD’s intended purpose. This includes selecting qualified clinical sites for target patient group enrollment, sample size calculation, definition of the appropriate diagnostic reference, study flow and endpoints as well as data to be captured. We prepare key documents such as the Clinical Performance Study Plan (CPSP) and the Statistical Analysis Plan (SAP).
Compliance and Ethics
We assist you in compiling comprehensive and complete applications for independent ethics committee (IEC)/ institutional review board (IRB) study approval and, where required, competent authority authorization or investigational device exemption (IDE) approval with the FDA. We ensure that your documentation is complete and compliant and that all communication with IECs and health authorities is performed correctly.
Clinical Site and Study Management
As a CRO, we act as a central point in sponsor/study site communication. We initiate study sites, develop and implement a comprehensive electronic data capture (EDC) system to ensure data integrity and validity and perform study close-out. We provide on-site and remote clinical study monitoring services. Our team controls adherence to schedules and timelines and reports to you at regular intervals so that you are informed on the progress of your study.
Data Analysis and Result Evaluation
Study result analysis and assessment concludes the clinical performance evaluation. We provide statistical analysis services and assist you in generating a clinical performance evaluation report (CPRP). In collaboration with the scientific affairs and compliance teams, we ensure that your performance evaluation report (PER) is comprehensive and ready for the notified body review.
How Can We Help You?
Rely on our expertise to determine the clinical performance of your IVD product successfully and efficiently.
Contact us, and we will be happy to provide expert guidance.
Julie Tantau, AuD
Head of Clinical Operations
Alicja Ritz, PhD
Senior Expert IVD
©
2025
ISS AG, Integrated Scientific Services