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Why Clinical Site Awareness Should Be Day Zero For SUSAR Reporting

Ask a handful of clinical research professional about the determination of "Day Zero" when reporting a suspected, unexpected, serious. ....

Penelope Przekop , Contract Research Organization , How Clinical Research Professionals Determine Day , European Union , Day Zero ,

6 Novel Mock BIMO Regulatory Inspection Exercises

Don't get caught on your heels. Conducting a mock regulatory inspection in preparation for an FDA, EMA, or other regulatory visit is a key. ....

Penelope Przekop , Bioresearch Monitoring Program Compliance , Monitoring Program Compliance ,

A 3-Point Strategy For Training Part-Time GCP Consultants

Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of. ....

Penelope Przekop , Fit For Purpose Process Ensuring , Require Appropriate Documentation , Part Time Consultant , Get Trapped In Your Learning Management ,

A 3-Point Strategy For Training Part-Time GCP Consultants

Global biopharma regulations and guidelines require that individuals involved in conducting clinical trials be qualified by a combination of. ....

Penelope Przekop , Fit For Purpose Process Ensuring , Require Appropriate Documentation , Part Time Consultant , Get Trapped In Your Learning Management ,

3 Strategies To Lead Clinical Research With Moral Integrity

In clinical research, perhaps our oldest code we live by is the Hippocratic oath. Our industry is more complicated today than ever before, so how can. ....

United States , Ravi Madan , Penelope Przekop , Robertm Persig , Eli Lilly , National Cancer Institute , National Cancer , Big Pharma , New Educational Opportunities , Even If It Requires Slowing Down ,