Our Services

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.

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.

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 clinical investigation plan serves as the foundation for the
intended clinical investigation. The CIP is written by our experts with extensive know-how in the design and execution of clinical trials. The trial planning is carried out according to the purpose and objective of the clinical investigation, from the feasibility study to approval and market surveillance. The CIP details how the product characteristics are to be validated, confirmed or identified in terms of safety, performance and risk-benefit assessment.

The clinical investigation plan serves as the foundation for the intended clinical investigation. It is developed by qualified professionals with expertise in study design and execution. The plan is structured to validate or challenge the manufacturer’s claims concerning safety, performance and risk-benefit assessment.

The investigator´s brochure is based on the technical documentation and compiles all clinically and non-clinically relevant information on the medical device under investigation. It is designed to support investigators and site teams in safely managing the device while minimising risks to study participants.

The clinical investigation report (CIR) is prepared upon completion of the study. It consolidates the collected data, compares study outcomes with predefined objectives and evaluates the safety and performance of the device. The CIR is submitted to regulatory bodies and made publicly available in the appropriate databases.

The clinical evaluation plan (CEP) outlines the strategy and methodology a manufacturer uses to demonstrate the safety and performance of a medical device. This essential document is required under MDR Article 61.

The clinical development plan (CDP) is a key component of the clinical evaluation plan. It includes relevant information on past, ongoing, and planned clinical investigations of the medical device, as well as associated documents such as clinical evaluation or investigation plans, reports, or study synopses.

We use extensive literature databases to research and identify publications that are relevant to your device. These include Embase and Medline. Search criteria to be considered may include: patient population, intervention, comparison, equivalent and similar devices and outcome.
Various databases can also be used to identify complaints as well as recalls that are related to the product, device or application in question.
The research allows evaluations to be carried out, the market situation and changes to be monitored and PMCF measures to be implemented.

The clinical evaluation report (CER) is the written compilation of all available evidence on the safety and performance of a medical device and is crucial for obtaining approval. The CER identifies equivalent devices and outlines a gap analysis. It addresses key points such as suitability for the intended purpose, positive benefit-risk profiles and non-inferior safety and performance objectives derived from the SOTA.

A post-market clinical follow-up (PMCF) report encompasses a continuous update of the clinical evaluation as outlined in the post-market clinical follow-up plan on the device in question. This plan specifies the methods and procedures to actively collect and evaluate clinical data of a CE marked device. The ultimate goal is to confirm the safety and performance of the device. The analysed data are then outlined in a post-market clinical follow-up report.

The periodic safety update report (PSUR) is an observation of the benefit-risk profile over time, providing a critical assessment at defined intervals after the device’s approval. The document is a critical analysis, encompassing new safety information emerging when the device is used as intended.

A post-market clinical follow-up (PMCF) report encompasses a continuous update of the clinical evaluation as outlined in the post-market clinical follow-up plan on the device in question. This plan specifies the methods and procedures to actively collect and evaluate clinical data of a CE marked device. The ultimate goal is to confirm the safety and performance of the device. The analysed data are then outlined in a post-market clinical follow-up report.

To plan, continuously conduct, and document a performance evaluation,
the manufacturer must establish a performance evaluation plan (PEP).
The PEP defines the performance evaluation process and outlines key
parameters, taking into account the intended purpose and use of the IVD, the specification of the analyte to be determined, the target patient groups, clear indications, possible contraindications, and limitations. Additionally, the PEP should detail the intended methods and statistical tools used to evaluate the analytical and, if applicable, clinical performance of the IVD.

A state-of-the-art (SOTA) service goes beyond literature research. It provides insights into current treatment options for the condition the device addresses and how the new device improves treatment outcomes.

The performance evaluation report (PER) combines all elements of clinical evidence and constitutes the key document for the IVD´s performance evaluation. As far as beeing applicable, it should include the scientific validity report, analytical performance report, and clinical performance report, along with an assessment of these reports to demonstrate clinical evidence, including a justification for the chosen approaches. The PER is continuously updated – annually for Class C and D IVDs, and as needed for Class A and B IVDs, based on new clinical data, post-market surveillance findings, or significant changes in the SOTA.

Clinical performance studies must be conducted unless a valid justification is provided for relying on alternative sources of clinical performance data, as stated in IVDR Annex XIII. These studies aim to establish or confirm aspects of device performance that cannot be determined through analytical performance studies, literature review, or previous experience from routine diagnostic testing. For example, they assess whether the device can accurately detect or measure the specified analyte within the intended environment and target patient populations.

In clinical affairs, manufacturers are advised on the development and implementation of clinical affairs strategies, covering all aspects of the device´s clinical application, including the planning, generation, collection and reporting of clinical evidence.

Manufacturers receive assistance in setting up and implementing risk management plans, including identifying risk analysis and the intended purpose of the device. A thorough risk assessment is integral to the process.

A technical documentation (TD) is a prerequisite for the conformity assessment and approval of medical devices. In consulting, manufacturers are guided in establishing comprehensive technical documentation and ensuring all necessary components are covered.

The implementation of a QM system is a fundamental requirement for medical device manufacturers. We support manufacturers in optimizing and developing an efficient QM solution that complies with international standards; in particular ISO 13485. Our QM service helps to identify requirements and suggests necessary adjustments.