The GermanNetPaeT offers a broad variety of consultancy and support services for all levels of paediatric clinical trials from Planning & Preparation to Implementation &
Trial Management as well as Training & Education.
We work in close collaboration with patient and parent representatives to align strategies, trial designs and paperwork with the real needs of concerned parties.
For specific service requests please contact email@example.com
The Coordinating Centers for Clinical Trials (KKS) and Centers for Clinical Trials (ZKS) provide the necessary human and logistical resources and competencies for their research partners to mutually plan, conduct and evaluate clinical trials.
At the national level, 24 academic study support structures are currently organized in the KKS-Network in order to be able to carry out an exchange and high-quality cooperation on study projects.
The study support of the members of the KKS network ranges from targeted assistance in individual sub-areas to complete supervision of studies. Services can be requested modularly and are based on the specific requirements of the client.
The KKS / ZKS offer concrete study support in the context of the development of new drugs, medical devices and therapeutic principles for national and international study projects. As scientific institutions, they provide human, spatial and logistical resources for medical research at the place of patient care, research and teaching in order to expertly accompany both science-initiated and commercial clinical studies.
The fundamental goal is to successfully coordinate and implement all processes of clinical trials with the necessary support.
The KKS ensure conformity and compliance with national and international legislation and communicate with authorities and ethics committees.
Cooperation partners benefit from the synergies within the KKS network. However, it should be noted that the core competencies and priorities may vary between different locations. In addition, the number of employees of the respective centers varies in size.
In the following, essential aspects of the different activities and tasks are presented, which can be carried out by one of the KKS / ZKS in the context of clinical studies. Due to the different orientation and structure of the individual KKS / ZKS, these are offered in different forms by the individual members of the KKS-Network.
In order to optimize and assure the quality of clinical studies, competent organization in all aspects is crucial. KKS / ZKS can take over the complete management of clinical trials.
Study planning and preparation:
Creation, ongoing update and coordination of study documents:
Management of all contracts in coordination with the involved bodies
The KKS / ZKS can undertake the biometric study planning and evaluation of prospective clinical studies in all indications.
The involvement of qualified biometrics at the earliest possible stage in study planning is decisive for high-quality studies and valid study results. The performance of statistical analysis in interim and final analyzes by qualified biometrics is also essential for valid study results. The evaluations are performed according to statistical analysis plans, which are already designed at the time of study planning.
Biometric study planning and evaluation includes the following aspects:
Data management is located at the interface between investigators, clinical monitoring and biometrics and works closely with other areas of the KKS / ZKS, such as project management, IT and quality assurance. The remit of data management extends from study planning to preparation of the data for statistical analysis. When carrying out data management, ICH GCP Guideline (ICH E6 (R2)) must be followed as well as other national laws and international guidelines. To ensure the validity of data from studies or other clinical research projects, quality management and quality control measures have been implemented in data management.
Study conduct and study closure
The continuous monitoring of clinical trials is performed by the clinical monitor. The monitor acts also on-site - at study centers - and as the link between the sponsor and the investigator. His main tasks are the supervision of investigators, the verification of collected study data and the assurance of compliance with current guidelines and laws of all staff involved in the study at site level. As part of their work, the monitors contribute significantly to the implementation of the ICH GCP guidelines in conducting clinical trials.
The scope of the monitoring includes among others:
In order to optimize and ensure the quality of the conduct of clinical studies, study nurses from KKS / ZKS support the work of the responsible investigators at some locations. The investigator team and the study nurses are qualified through certified courses and work in accordance with national and international clinical trial regulations, i.a. Good Clinical Practice (ICH-GCP) and other legal requirements.
KKS / ZKS offer support for vigilance tasks in clinical trials in accordance with the applicable legal requirements.
Exemplary services can be offered in the field of pharmacovigilance in clinical trials with medicinal products:
In general the IT infrastructures that can be used to prepare, execute and evaluate all types of clinical trials is provided by the IT Development and IT Support.
These infrastructures may include the following solutions to assist in clinical trial work:
Furthermore, the IT teams form the interface with the respective university computer center.
A quality management and assurance system is essential for the adherence to and implementation of the mentioned range of services.
In accordance with the requirements of the ICH Guideline E6 "Good Clinical Practice", the KKS / ZKS have established a standardized, risk-based quality management system, which is continuously being improved and further developed. The employees of the quality management monitor planning, execution and evaluation of the clinical trials in accordance with the respective QM system.
Most quality assurance systems are based on standard operating procedures. SOPs are important quality management tools in clinical trials. One of the first tasks of the KKS-Network was to develop harmonised SOP templates on which the current SOPs of the individual centres are still based today.
As a clinical research service institution, KKS / ZKS are subject to regular monitoring by the competent authorities within the framework of inspections.
In addition, monitoring by cooperation partners and clients takes place within the framework of vendor audits.
The conduct of clinical studies is becoming increasingly complex. Ensuring quality in clinical trials requires expertise and compliance with international standards. The courses offered by KKS / ZKS provide knowledge of the principles and methodology of clinical studies and introduce current guidelines and organizational aspects of the implementation. The topics range from planning the study, legal issues, adhering to Good Clinical Practice (ICH-GCP), creating study documents, to quality control and data management. The courses are curriculum based and certified.