Clinical Study Compliance |
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The
Compliance of a Clinical Study may depend on the capability of
interaction between the key players (Sponsor, CROs, Laboratories
etc.): these players may have their own Quality System, procedures
and organizational structure, and this might be a serious obstacle
to meet the overall compliance of the specific clinical study.
K2C act as a partner facilitating the communication between these key players, ensuring the required collaboration in all quality and regulation requirements.
We may also help your organization in finding the appropriate partners or in managing large projects, as per your requirements.
K2C consultancy services include:
Project Management
Definition/review of Quality System and associated procedures
Definition/review of Clinical Study Protocol
Data and Discrepancy Management
Data Coding
Trial Management
Biostatistics’ analysis and related reports
Computer System Validation