ANI Pharmaceuticals (ANIP)

[Just the facts maam]

Yodle, just wanted to point out something about Linda Andrews, this was her Linkedin work history before she changed it, while still working at Abbott Labs. Now in my conversation with Simes he said he did not remember, nor would she of had anything to do it changes to clinical trials. Her highlighted work history in its original form contradicts this statement.

Document Specialist/Editor
BioSante Pharmaceuticals
November 2009 – March 2010 (5 months)

Ensured regulatory document compliance with IRB, FDA, OSHA and ICH regulations and site level Safety SOPs (standard operating procedures) and policies

Liaison between sites and sponsor, fielding questions and concerns

Prepared documentation for FDA Regulatory Submissions (i.e., new investigators, CVs, protocols, amendments, newsletters, correspondence, source document worksheets and CRFs)

Created, designed, reviewed and distributed monthly Study Newsletters to sites and CRAs

Performed Clinical Trial Management System (CTMS) database administrator activities:

Assisted in implementation of the new CTMS database to maintain and track documents

Renamed historical regulatory documents using new naming convention
Ensured accuracy by linking regulatory documents in the database (i.e., IRB and site approvals, 1572s, Medical and DEA Licenses, correspondence, etc.)

Reviewed CTMS for missing or expired documents and resolve discrepancies
Communicate with outside vendors regarding issues or discrepancies
Ensure the secure receipt, storage, tracking, maintenance and retrieval of all confidential regulatory documents, according to ICH, GCP, GMP and GDP guidelines.

Maintained hard copy files in support of electronic files. Perform file audits to ensure accuracy.

Along with the statement that the safety trial was not measuring efficacy, that is two contradictions that I can attribute to Simes during our conversations. This was possibly a big mistake, since it confirmed I was onto something and only encouraged to me continue digging deeper.