Whitepapers & Publications
Our staff is actively involved in the industry and is committed to providing information on the latest topics and trends. To view our whitepapers and recent publications, click the links below.
- Types of In Vitro Diagnostics: Clearing up the Confusion
- What could proposed changes to the Common Rule mean to sites, sponsors and IRBs?
- Risk based decision making in determining whether drug research requires an IND
- Trends and Insights in IRB Warning Letters
Cureus Article, entitled “A Framework for Navigating Institutional Review Board (IRB) Oversight in the Complicated Zone of Research”
Gretchen E. Parker, PhD, RAC, CIP
RAPS Article (Login and Password required), entitled “Types of In Vitro Diagnostics: Clearing Up the Confusion”
Heidi Hancock Strunk, RAC
RAPS.org Article (Login and Password required), entitled “Regulatory Approval of Biosimilars: a Global Perspective”.
Gretchen Miller Bowker, MS, RAC, FRAPS; Gretchen Parker, PhD, RAC; Sarah Witwer, JD, RAC
Sage Journal Article (Login and Password required), entitled “Labeling Standards for Biosimilar Products”.
Gretchen Miller Bowker, MS, RAC, FRAPS, Gregory C. Davis, PhD (Davis Consulting Services, LLC)
Factors related to immunosuppressant medication adherence in renal transplant recipients
Co-Authored by Gretchen Parker, PhD, RAC