Payal Cramer

Welcome to the Future: HHS Releases Final Rule to Modernize Protections for Clinical Trial Participants

By Kyle Gregory and Payal Cramer on February 2, 2017 Posted in Uncategorized

The Federal Policy for the Protection of Human Subjects, or the “Common Rule,” governs the ethical conduct of research involving human subjects and is funded through various federal agencies. On January 19, the U.S. Department of Health and Human Services in collaboration with 15 other federal agencies (the Agencies) issued a Final Rule to update the Common … Continue Reading

More Than the Leaves Are Changing: Clinical Trial Research Regulations and Policies Get a Fall Makeover

By Payal Cramer and Ernessa McKie on October 24, 2016 Posted in Uncategorized

These changes represent a new season of responsibilities for those who manage and oversee clinical trials. The Food and Drug Administration (FDA) and National Institutes of Health (NIH) have recently finalized or signaled intent to finalize numerous proposals that promise to change the landscape of clinical trial reporting, clinical researcher responsibility and Institutional Review Board … Continue Reading

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

By Payal Cramer and Greg Fosheim on June 24, 2015 Posted in Uncategorized

“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether involving a patient, provider, or industry, the government closely scrutinizes quid pro quo arrangements when the government foots the bill. Clinical trial sponsors … Continue Reading