article thumbnail

How AL/ML based solution can help extract clinical data from Source and CRF documents in a clinical study

Cloudbyz

Understanding Source and CRF Documents Source documents refer to any documentation that provides original information about a patient, including medical records, physician’s notes, laboratory reports, and radiology reports. On the other hand, CRFs are electronic forms used to collect and manage clinical data in clinical trials.

article thumbnail

Key Items Auditors Look for When Reviewing an Investigator Site File

Advarra

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct is complicated. Investigator Site Files The ISF contains essential documents permitting evaluation of a clinical trial’s conduct. Remember, some staff may not need protocol-specific training.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Hypoxia-Inducible Factor-2 Alpha (HIF-2?) Inhibitor WELIREG™ (belzutifan) for the Treatment of Patients With Certain Types of Von Hippel-Lindau (VHL) Disease-Associated Tumors

The Pharma Data

The WELIREG label contains a boxed warning that exposure to WELIREG during pregnancy can cause embryo-fetal harm. The major efficacy endpoint for the treatment of VHL-associated RCC was ORR measured by radiology assessment using RECIST v1.1 As an inhibitor of HIF-2?, WELIREG reduces transcription and expression of HIF-2?

article thumbnail

The Utility of Liquid Biopsy in Oncology Clinical Trials

XTalks

“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinical research organization (CRO) Medpace.

article thumbnail

Sequana Medical Appoints Two Additional Experts as Heart Failure Scientific Advisors

The Pharma Data

He is Director of Cardiovascular Research at the Duke Clinical Research Institute and Vice-Chief for Clinical Research in the Division of Cardiology. Udelson, MD is Chief of the Division of Cardiology at Tufts Medical Center and Professor of Medicine and Radiology at Tufts University School of Medicine.

article thumbnail

COVID-19 Pandemic Coverage

XTalks

“Vaccine Nationalism” Could Prove the Undoing of COVID-19 Containment. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. Continuing trends suggest the worst may be over provided the outbreak is contained over the next few months.