A solid study design is the most important prerequisite for obtaining reliable and meaningful clinical data. Together with you, we define the objectives of your clinical trial and support you in the selection of optimal methods and relevant endpoints. In this way, you obtain results that are not only reliable, but also informative.

We ensure that all trials are conducted in accordance with the Clinical Trial Regulation and ICH-GCP (Good Clinical Practice) guidelines to ensure the quality and integrity of your research.

From the early findings of Phase I and II to the refinement and development of your study plans for the later study phases – we are with you every step of the way to get your clinical research on the road to success.

The development up to CE certification and market launch of medical devices requires a high level of expertise and compliance with strict legal requirements. We offer comprehensive support in the planning, implementation, evaluation and publication of clinical trials and other studies to collect relevant data in accordance with the EU Medical Device Regulation (MDR), ISO14155, the Medical Device Law Implementation Act (MPDG) applicable in Germany and other international and national regulations.

In close cooperation with you, our regulatory experts and the notified body, we ensure that all regulatory documents required for CE certification are available and that all safety and quality requirements are met. In this way, we ensure that your medical device successfully makes its way to market launch, offers users real added value and lasts throughout the entire product cycle.

In contrast to medicinal products, the clinical testing of medical devices does not take place in separate phases I-IV. Depending on the risk class of the medical device, clinical trials are necessary as part of the so-called conformity assessment procedure in order to substantiate the basic safety and performance requirements formulated in the intended purpose with evident clinical data. The clinical data is summarized in a product-specific “clinical evaluation report”, which must be kept up to date even after CE certification. This means that further clinical trials may be necessary even after a successful market launch.

Clinical trials of both medicinal products and medical devices are characterized by strict specifications and controls of the patient population through inclusion and exclusion criteria and specifications regarding the course of treatment.

We plan and supervise non-interventional studies (NIS) such as observational studies, case-control studies, cohort studies and registry studies with expertise and precision. The focus of such studies is on valid data collection and the analysis of the therapeutic success – and possibly the further course of the disease – of a treatment in everyday clinical practice in a larger patient population. These studies can therefore only be carried out after approval. Data is collected without specific interventions by defining strict inclusion and exclusion criteria and can therefore cover a larger patient population during the course of treatment.

The data for this come from existing (retrospective) or starting (prospective) routine treatments in accordance with the approval and are planned, structured, conducted, processed and analysed by us just as carefully as phase I – IV studies or performance trials.

Non-interventional studies are an essential part of pharmacovigilance and contribute significantly to the further development of drugs or forms of therapy. They provide practical findings that optimize the use and safety of treatments in the long term.

In a non-interventional study, a patient is examined in accordance with the approval and taking into account the applicable treatment guidelines; this means that no additional x-rays, blood samples or other stressful measures are taken that are not provided for in the approval of a product. If, on the other hand, a clinical project deviates from the approval and, for example, an additional blood sample is taken or more frequent X-rays are taken, additional interventions are carried out from a legal point of view and thus automatically constitute an interventional study.

The distinction between interventional and non-interventional studies is also reflected in the respective regulatory requirements. The approval process for interventional studies is significantly more complex. Among other things, the approval status of the product, its type (medicinal product or medical device), the purpose of the study (scientific or commercial) and the classification of medical devices (class I-III) play a role here. After approval, various reporting obligations must also be fulfilled. Non-interventional studies are generally subject to notification requirements. Even if this process is less complex than for interventional studies, the correct classification of the study (e.g. as an observational study, non-interventional safety study, etc.) and compliance with the relevant regulations remain crucial for the success of the entire procedure.

With our many years of expertise, we are always on hand to advise you on how to classify and choose the right strategy.

In addition to the creation of the study design, project management in clinical trials makes a decisive contribution to the efficiency and scheduled execution of clinical trials. As an experienced Clinical Research Organization (CRO), we coordinate and control the entire process of clinical trials – from the careful planning of the trial design to the selection of suitable trial sites and contract management. We act as an interface for communication between all parties involved – from the sponsor, the principal investigator and the other study sites to the responsible authorities and ethics committees.

Our project management acts as a single point of contact for all information and control elements for your study.

Careful monitoring is essential to ensure data quality in clinical trials. Monitoring is therefore a mandatory quality assurance measure in accordance with international and European legal requirements (GCP and EU CTR). Even before the start of the clinical trial, we coordinate the internal and external processes and train the trial staff during on-site initiation visits. In this way, we ensure that the study is started according to protocol and that the technical and organizational preparation is optimal.

During the course of each clinical trial, we continuously monitor and document compliance with the trial protocol and legal requirements in accordance with Good Clinical Practice (GCP). In close coordination with the study sites, we check the clinical data collected on site or remotely using electronic Case Report Forms (eCRF). In the event of inconsistencies or incomplete data sets, rapid intervention or correction is possible to ensure data quality and completeness.

After completion of the study, we take care of all necessary formalities as part of the close-out process and ensure that the study results are archived in a legally compliant manner – even for non-interventional studies.