Monitoring and Project Management
Cardinal Systems - Bio International Convention - May 4-6, 2010 @ Chicago
Services
Cardinal Systems' portfolio of services range from conception and realisation of the different aspects of a clinical trial through to exploitation of the results and their presentation for submission to the appropriate regulatory authorities and/or publication.
In particular, we provide the following services:
- Advice on methodology or statistical analysis (study design, statistical analysis plan, review of the investigator’s brochure, regulatory issues)
- Monitoring (including the management of specialist technologies and resources) and project management (complete management of the project including contract specifications, hiring/management of external specialists and monitoring/reporting)
- CRF design and data management (data entry, validation)
- Installation and maintenance of Internet applications (e.g. InfoGate®, a company innovated electronic workflow solution for eMonitoring, EDC and eCTD)
- Statistical analysis
- Preparation of ICH E3 study reports, their annexes and eCTD
- Randomisation and logistics centralised by a vocal or a web server (IVRS/IWRS (IxRS))
- Medical Imaging services, designated to standardise acquisition and evaluation
Our services also include conception and realisation of surveys (classic or by Internet).
