The Pharma Data

MARCH 20, 2021

After a year of unprecedented disruption in the clinical research industry, 2021 is set to be another transformative year for sponsors and contract research organizations (CROs), according to John Reites, president of Thread, a technology and service provider focusing on decentralized clinical research.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

XTalks

JUNE 4, 2024

Cohen says this new infrastructure has been unveiled at Fortrea’s Leeds location in the UK and expanded to a couple of US clinics to include new Current Good Manufacturing Practice (CGMP) pharmacies. This is all done to protect the safety and well-being of research subjects, which is always paramount.

Clinical Development 110

Clinical Development Development Clinical Trials Clinical Trials 110

Advarra

JUNE 28, 2022

Using nonclinical data or manufacturing information that doesn’t adequately support the clinical protocol hurts the IND application. It’s critical to ensure all nonclinical data supports the clinical design and provides adequate justification of the desired labeling claims – including basic exposure data.

Regulation 52

Regulation Drugs Manufacturing Development 52