CERES Service

Good project management ensures seamless coordination between the sponsor, investigation site, principal investigator (PI), monitor, ethics committee (EC), competent authority (CA) and medical writers. Our project management ensures that all critical decisions and documents are thoroughly reviewed and guarantees that quality and timelines are reliably met.

Whether in the pre-market or the post-market phase – a clinical investigation can be useful across all different product life cycle stages. We plan and execute the different investigation designs in accordance with the respective stage of your medical device in the clinical product life cycle: exploratory, confirmatory or observational. Our core skills encompass the capability of providing the carefree package of all the different clinical investigation types: first in human, feasibility, pivotal, post-market observation, registry, interventional or non-interventional investigations. Included in our full-service clinical investigation package are project management, medical writing services, the statistical analysis plan and report, data management, monitoring as well as vigilance and safety. If you do not need the whole clinical investigation package, book our modular service individually. We take charge of your current situation – whether you need to obtain or maintain market access. We are your strategic partner at eye level.
Our clinical investigation procedures follow the requirements of the 2017/745 Medical Device Regulation (MDR) Articles 61-82 as well as national requirements.

The biostatistician supports clinical investigations by determining the
appropriate sample size, developing statistical analysis plans (SAPs) and conducting data analyses upon study completion. The resulting statistical analysis report (SAR) ensures data integrity and compliance with regulatory requirements. Whether for regulatory submissions or scientific publications, biometricians tailor statistical methodologies to align with study endpoints and hypotheses, providing robust and reliable results.

Safety refers to the reporting of any (serious) adverse events with a
causal relationship with the device under investigation and/or any device
deficiencies that could potentially have led to an (serious) adverse event had no appropriate action been taken. In addition, the handling of medical device complaints is also included.

Monitoring is the means to oversee the progress of a clinical investigation and to ensure its accordance with the clinical investigation plan. This guarantees that the conduction, recording and reporting are uniform, plausible and correct and that the investigational site files are kept up to date. Monitors verify the source data and ensure the recruitment and patient informed consent procedures are followed appropriately. The monitors, clinical research associates (CRAs), are the first point of contact for the investigational sites. Monitoring supports both sites and data management in clarifying any questions that may arise.

Data management is responsible for reliable date, recording and processing of data as part of a clinical investigations. For this purpose, case report forms (CRFs) are created in accordance with the protocol. The quality of your data is ensured by reviewing and clarifying open questions. In addition, data management maintains and archives the associated databases and manages the various user accesses for investigators, monitors, etc.