In the News
Changing the face of the clinical trials industry
Chris Clendening and Brent Reed discuss the PPD® Laboratories Preclarus® investigator site portal and companion mobile application, which were acknowledged for industry leadership in the CenterWatch Monthly 25th anniversary special edition, which spotlights top innovators in clinical research.
PPD, Quotient Sciences pen pact to speed up therapies aimed at kids
Collaboration will enable the companies to jointly provide a one-of-a-kind offering that meets the needs of patients and regulators in the development of pediatric drug products.
PPD Partners With UK Firm To Speed Pediatric Drug Development
Karen Kaucic explains that the new program was established in response to increasing customer demand, as well the drive by regulatory agencies to promote the development of new medicines for children.
PPD, Quotient to support entire pediatric program through single contract
Karen Kaucic announces a new collaboration to accelerate pediatric drug development.
Single-Use Bioreactors Pose E&L Challenges
Derek Wood comments on the challenges posed by single-use bioreactor bags in contributing to extractables and leachables in the biomanufacturing process.
A New Regulatory Paradigm for Medical Devices in India
Vibhu Yadav, Dushyant Kumar and Nancy Mathewson outlines medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.
The Medical Device Coordination Group: A New Authority Under EU Device Regulations
This article by Robert Cumming and Nancy Mathewson discusses the organization and functions of the Medical Device Coordination Group established under the new EU Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation.
Analytical Testing – Extractables and Leachables Testing for Pharmaceutical Products
Xiaochun Yu and Derek Wood provide a detailed overview of extractables and leachables.
The Virtual Opportunity in Rare Disease Trials
In this article written by Karen Kaucic, Horacio Plotkin and Christopher Komelasky, the authors discuss how rare disease research can be solved with virtual trials and their supporting technologies.
