article thumbnail

Integrate RBQM Into Each Phase of the Clinical Trial “House”

WCG Clinical

Risk-based quality management (RBQM) isn’t something you merely add to an existing clinical trial. That is what we really should be basing the foundation of all our clinical trials on.” The “construction crew” should include more than the clinical operations team.

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. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based

Insiders

Sign Up for our Newsletter

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

article thumbnail

OncoHealth Expands Its Iris Platform for Digital Cancer Care

XTalks

During the pilot phase, 43 percent of members actively engaged with the Iris clinical team, which comprises nurses and mental health experts, with an average of 2.3 Last year, OncoHealth launched an innovative pilot program for its groundbreaking digital health service, designed to support members undergoing cancer treatment.

Nurses 98
article thumbnail

NICE backs Astellas’ oral therapy Evrenzo for anaemia in kidney disease

pharmaphorum

Evrenzo – originally developed by FibroGen – is licensed to Astellas in Europe, where it was approved by authorities in the UK and EU last year. The drug works by activating the body’s natural response to reduced oxygen levels in the blood, increasing red blood cell production.

Nurses 57
article thumbnail

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Drugs 110
article thumbnail

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

Pfizer

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g.,

Drugs 69
article thumbnail

RECOVERY Trial Data Monitoring Committee Recommends Continuing Evaluation of REGN-COV2 in All Hospitalized Patients

The Pharma Data

About the Trial The RECOVERY trial is conducted by the registered clinical trials units in the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine. The DMC letter is available here: [link]. Department of Health and Human Services under OT number: HHSO100201700020C.

Trials 52