Clinical Research Regulations White Paper 
PPD
NOVEMBER 18, 2024
Effective monitoring of regulatory intelligence comes with big challenges The challenges inherent to PV RI encompass more than just regulatory complexity — though complexity is a major factor, given regulations are continually created, updated or revised, at all levels (regional, national and global), often all at the same time.
PPD
OCTOBER 2, 2024
Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.
PPD
JULY 16, 2024
Our recent white paper explores the many ways in which a functional service provider (FSP) engagement delivers key pharmacovigilance (PV) capabilities necessary across the product life span and across different geographical regions. Working with a committed and experienced FSP PV partner is often the best way to achieve success.
PPD
AUGUST 28, 2024
Regulators and payors also demand a higher volume of data collection for these studies. The PPD clinical research business of Thermo Fisher Scientific’s expert teams have conducted over 160 immuno-oncology studies, more than 137 CGT studies and 263 early phase oncology studies, covering a wide range of tumor types and therapies.
Agency IQ
APRIL 12, 2024
Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. At a February 2024 joint workshop with the U.S. Next, the U.S.
Agency IQ
FEBRUARY 21, 2024
Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.
Drug & Device Law
JULY 31, 2023
It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. at 77 (citation omitted).
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