Whitepapers and 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.

Whitepapers

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 

Publications

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 publication, entitled “Global Medical Device Regulatory Strategy”

  • Contributor Gretchen 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)

ACRP Monitor ArticleHuman Research Protection:  Not Just an Obligation, a Careerpage 21-22.

  • Gretchen Miller Bowker, MS, RAC
  • Craig B. Caldwell, MBA, PhD

Factors related to immunosuppressant medication adherence in renal transplant recipients

  • Co-Authored by Gretchen Parker, PhD, RAC