Know-how for clinical trials
Central elements of the services offered by the ZKS Münster are, in addition to a cross-institutional quality management program, a comprehensive and GCP-compliant data management concept, an excellent pharmacovigilance system, a Central Study Management, competent monitoring and auditing as well as in close cooperation with the Medical Association of Westphalia-Lippe and recognized by the ethics committees, always up-to-date and continuous further education and training.
Consulting at the highest level
The successful implementation of clinical research projects requires sound planning and preparation. The central task of the consulting service is to support the implementation of scientific questions in drug and medical device studies as well as in biomedical research projects. In addition to the co-development of the study design and advice on regulatory aspects, it also includes support for funding proposals (et.al. DFG, BMBF, EU, German Cancer Aid, etc.).
Central Study Management
The Central Study Management offers study directors of science-initiated studies support throughout the entire course of study. Depending on requirements, only individual, but also all tasks of the study management can be taken over: From the preparation of the trial protocol to the application to the competent and local authorities, as well as to the ethics committees, to the final report ZKS Münster supports in a timely study execution and the achievement of the recruitment goals.
Established Safety Desk for Pharmacovigilance
The ZKS Münster has special competence in the field of safety management. The Safety Desk has been in existence almost a decade and is equipped to support large-scale, international studies through safety monitoring and the fulfilment of reporting obligations. It has established structures and an E2B-compliant database that enables electronic SUSAR reporting. It supports both drug and medical device studies over their entire project duration in accordance with the respective legal requirements. This begins with the preparation of the trial protocol and SAE registration forms, includes, among other things, the processing of SAE reports and the preparation of annual safety reports during the study period and includes a comparison of the study and SAE database at the end of the study. Qualified MedDRA coding is of course also part of the portfolio.
Comprehensively integrated Data Management
The data management of the ZKS Münster supervises the entire process of GCP-compliant data collection and processing from the planning phase to the completion of studies. Studies can be conducted both paper-based and as EDC studies (Electronic Data Capture) with web-based online randomization. Here, data management works closely with internal ZKS functional areas such as monitoring, pharmacovigilance and central study management as well as with investigators, study leaders and external biometricians. Quality assurance and quality control processes are used to check the study data and to ensure its validity as well as to support central monitoring. Extensive data processing in SAS to prepare the biometric evaluation will also be carried out.
Monitoring is an essential instrument of quality control by the sponsor, which is explicitly required by the ICH-GCP Guideline. The monitoring division of the ZKS Münster has been working for many years for internal and external clients of a wide variety of studies in various indication areas. Qualified and experienced employees carry out trial site initiations, regular monitoring visits during the study and final close-out visits at the end of the study. In addition, the flexible and highly motivated team of the division has experience in carrying out monitoring abroad.
Current and continuous Training and Education of study staff
The qualification of the personnel involved in clinical trials is required by the legislator and is one of the basic prerequisites for the successful conduct of clinical studies. The ZKS Münster therefore regularly offers courses for study staff of various functions. Many events are held in cooperation with the Medical Association of Westphalia-Lippe. All courses aimed primarily at investigators are certified by the Medical Association of Westphalia-Lippe, awarded further training points and recognized by the ethics committees. In addition to the regular range of courses, the ZKS Münster also carries out tailor-made training measures in the trial sites on site or as part of study initiations.