Global Standards (e.g. ICH-GCP)
Accepted uniform global standards are the basis of all national and international research projects supported by the ICN. The services provided by ICN experts can support all research departments of the various ICN members in the planning and conduction of their clinical trial projects in compliance with national and local law as well as international standards (e.g. Good Clinical Practice, GCP, of the ICH). Existing expertise can be shared and experts connected. In addition, the ICN offers various proven training courses in the field of international standards.
Trial Management and Operations
The ICN's consulting services range from data management and monitoring to provision of facilities (e.g. fully equipped Phase-I-Unit for in- and out-patients), equipment and specialist personnel for the optimized planning and conduction of clinical research projects (Phase I-IV). ICN members can offer different solutions including isolated services up to fully staffed CRO services.
Quality Management is the key to happiness in clinical research and the heart of every project and clinical research infrastructure. By adapting proven quality management systems (QMS) of ICN members, a high-level system can be reached in a very short time. The ICN can not only provide support in creating quality documents but also in how to implement a QMS for all practical purposes.
If you wish, you may be audited by one of our quality controllers thereby ensuring ICH GCP is correctly implemented and you are adequately prepared for regulatory inspections.
Supporting Tools and Services
We are all aware that a key factor of success is that each center’s situation is different and we have to complement one another, i.e. support each other with top-level capabilities.
Beyond the core areas already addressed in the service portfolio, further supporting services are needed usually.
Such supporting services can be, for example, tools & technologies (such as advice to build up study approval systems or registries, data analysis tools, a system for more efficient patient recruitment, etc.) or access to sponsors of multi-center studies.
Some of these supporting services are offered by ICN members, some others by commercial companies (both large and small) with which ICN members have made good experience. The ICN can put you in contact with them, depending on your needs.
Local Standards & Regulations
The ICN connects excellence in planning and realization of clinical trial projects in compliance with local research acts, its ordinances and regulations and the international Good Clinical Practice Standards (ICH-GCP).
ICN members in your country can help you cope with local standards and regulations, via standardized services and / or individual advice.
Building up infrastructure for clinical research requires know how about regulatory requirements for infrastructure (Clinical Trial Unit, Phase I Unit, Study Sites, etc.), about the organization and capabilities of personnel, about equipment, a Quality Management System and other topics.
The ICN provides an adaptable system to build up research infrastructure and its corresponding education courses. Upon request, experts can accompany you on this path and can provide advice on building up new or strengthening existing teams.