Global Clinical Partners, Inc. "GCP - not just who we are, but what we do."

Educational programs, seminars/webinars and pdf slide sets available upon request. Topics include, but are not limited to:

1.	Responsibility: the Key to uncompromised Data PI Responsibility as ICH prescribes PI Responsibility as FDA prescribes The Certified Physician Investigator (CPI)
2.	Human Subject Safety Ethics in Clinical Research - Protecting Human Subjects - An overview
3.	Informed Consent - the Process - what it is and how it is essential
4.	Oversight in Clinical Research - How Important - IRB, REB, IEC by any name The IRB and Human Subject Protection
5.	Clinical Trail management - putting it all together Understanding 21 CFR Part 11 - Overview of Computer use in Clinical Research Protocol Deviations / Violations - Why this is important to know
6.	Recruiting Study Participants - What are the steps
7.	Health Insurance Portability and Accountability Act of 1996: HIPAA overview
8.	FDA Audit / Inspection - What to expect and how its done FDAs Role in Drug / Device development
9.	Regulatory Control of Drug Development - How and why Comparing ICH with the FDA CFR
10.	Importance of SOPs - What are they - how are they set-up
11.	Adverse Event Reporting in Clinical Research - Importance and the algorithm needed Adverse Device Effects / UADE - Importance MedDRA Overview Risk Management in Clinical Research
12.	Laboratory Data as AE's - Understanding Lab data as AE's Good Laboratory Practices (GLP) Overview
13.	Drug-induced Hepatotoxicity - How to identify it & what is its role in drug safety
14.	Pharmacovigilance (Post Marketing drug Safety) - why it is important
15.	Data and Safety Monitoring - How Important are DSMP's and DSMB's
16.	Confined Studies: Phase I and IIa - What are they and how are they set up
17.	Phase I - "First-in-Man" - What is special about early trials with a new drug
18.	PK / Metabolism / Interactions for Investigators - Basic overview
19.	GCP, an Investigators update - the elements of GCP
20.	Documentation in Clinical Research - Importance and how to do it
21.	Conflict of Interest Guidelines (CoI) - the importance of having a system