Compliance

Regulations we apply to clinical research

HIPAA, 21 CFR Part 11, GDPR, and FISMA. How Trialinx meets each, ethics committee documentation, and checklists for legal teams.

HIPAA

US protected health information.

Estados Unidos

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21 CFR Part 11

FDA electronic records and signatures.

Estados Unidos (global FDA)

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GDPR

EU personal data protection.

Unión Europea / EEE

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FISMA

US federal security controls (NIST).

Estados Unidos (gobierno federal)

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Need the package for your ethics committee or DPO?

Contact us and we'll send all the documentation your ethics committee or data protection officer needs.

Request documentation