In regulatory medical writing, we prepare all documents and documentation required by the various parties involved in the various stages of a clinical trial.

 Ahead of the clinical trial, we prepare the documents for submission to the ethics committee. We formulate detailed study protocols and investigator brochures which, alongside the patient informed consent documents, form the basis for conducting the clinical trial.

 Once the study has been completed, we prepare the final report in accordance with the relevant regulatory standards:

• Clinical Study Report (CSR) for medicinal products – in accordance with the ICH E3 guidelines.
• Clinical Investigation Report (CIR) for medical devices – in accordance with the ISO 14155 standard and the requirements of the MDR (Medical Device Regulation, EU 2017/745).

Compliance with the relevant guidelines is crucial for the successful and rapid approval of the product or the extension of an existing approval.

The statistical and data management processes make a decisive contribution to obtaining legally compliant, relevant clinical data of the highest quality and statistical significance for meaningful results.

We provide you with comprehensive support in statistical planning and data management, analysis, interpretation and summarization in the final report so that you comply with these regulations.

 To this end, we already consider the conformity of the data to be collected with standards and regulations when drawing up the study protocol: By calculating the number of cases, defining and formulating the endpoints, selecting the statistical strategy and statistical procedures and the data collection, processing and standardized methods of data collection and data management based on these.

The handling of highly sensitive clinical data – from planning and collection to analysis and publication – is subject to strict regulations, including those laid down by the European Medicines Agency (EMA) and the US FDA.

 We support the study sites in the secure and efficient electronic compilation of raw data from various sources into the database system used. With the support of our qualified monitors, our experienced statisticians check the collected data for completeness and plausibility, clean it up, prepare it and evaluate it in accordance with the study protocol.

 The data collected as part of a clinical study is not only valuable in terms of an individual clinical study report. Even after the clinical study has been completed, additional insights can often be gained from the available data – for example by differentiating between specific subgroups (post-hoc analysis), pooling or meta-analyses.

We create concepts for the design of individual Case Report Forms (CRF) to record patient-based examination data – both analog (on paper) and in electronic form (eCRF). One advantage of the electronic version is its greater efficiency and reliability, as results do not have to be manually transferred to the database. This eliminates potential transcription errors. Another advantage is that all data is available directly in the database and results can be monitored in real time. The processing of events (see also pharmacovigilance) is also much faster and more reliable with an eCRF.

Thanks to our in-depth expertise in data management, we design and program GCP-compliant, logically structured and, above all, user-friendly eCRFs with all the necessary interfaces to ensure seamless integration and effective management of study data.

All these arguments speak in favour of electronic data collection. There are only a few cases, for example studies with very low case numbers/case statistics depending on the indication and the patient clientele (e.g. patient diaries in geriatrics), where we recommend data collection on paper.