New global IIT guides
July 10, 2014
Novartis Pharmaceuticals has
released new global guidelines for
Investigator Initiated Trials (IIT),
tightening its internal processes and
governance measures.
An IIT may be a clinical
or non-clinical study and is
conducted without the company’s
participation, where the sponsor
asks Novartis to provide either
funding, drug product or both.
The new guidelines were based
on six principles including robust
governance systems within
Novartis, global training on the
guidelines for Novartis associates,
including the rules of independence
of third party investigators or
supporters, financial transparency
on funding support and
requirement for third party
sponsors to publish findings and
safety information, the company
said.
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