Accepted uniform global standards are the basis of all national and international research projects supported by CRUise . The services provided by CRUise experts can support all research departments of the various CRUise 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, CRUise offers various proven training courses in the field of international standards.
CRUise's consulting services range from clinical services to facilities consultation, as well as specialized personnel for the optimization of planning and conduction of clinical research projects (Phase I-IV).
Quality Management is the key to clinical research and the heart of every project. By adapting proven quality management systems (QMS) of CRUise members, a high-level system can be reached in a very short time. CRUise 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.
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 CRUise members, some others by commercial companies (both large and small) with which CRUise members have good experience. CRUise can put you in contact with them, depending on your needs.
CRUise 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).
CRUise 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.
CRUise 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.
International studies require a careful and committed level of Project Management and technical oversight. Therefore, CRUise members offer solutions for data exchange and analysis.