Noncompliant Clinical Trial Transparency

Posted by Thomas Wicks on Jun 6, 2017 10:07:55 AM


OVERVIEW:

Regulatory Risk is the possibility that changing regulations will significantly affect the organization, requiring additional investments, changes in operations, or other adjustments to address competitive and compliance issues.  The related Compliance Risk is the potential that your organization is in violation of regulatory requirements leading to fines, reputational impacts, and even delays or denials of regulatory approvals.   In the context of clinical trials transparency, this means anticipating, interpreting, and tracking global regulatory requirements, continuously monitoring compliance, and coordinating disclosure across departments, partners, and affiliates.


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Topics: Clinical Trial Disclosure, clinical trial transparency