PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

Trials 52

Trials Clinical Trials Therapies Drug Development 52

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.

Regulations 40

Regulations Trials Science Clinical Trials 40

The Pharma Data

SEPTEMBER 1, 2020

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. The patient experience is an important consideration in trial design. Innovative ways regulators are implementing new clinical practices to measure the patient perspective.

Clinical Trials 52

Clinical Trials Trials Regulations Production 52

Agency IQ

JULY 21, 2023

The assessment of this benefit typically relies upon the use of specific endpoints to measure this clinical benefit, generally within the context of a clinical trial. [ OS is an outcome-related endpoint that is defined as the time from trial randomization until death from any cause in the intent-to-treat population.

FDA 40

FDA Clinical Trials DNA Treatment 40

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.

Compliance 52

Compliance Regulations Production International 52

Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. A few months ago, one participant in a clinical trial for a CRISPR-based gene therapy for Duchenne muscular dystrophy suddenly died. It’s gonna be used for phase 3 trials of a C. .” Nature Genetics. This review is a good place to start.

Vaccine 52

Vaccine Engineering DNA RNA 52

Codon

APRIL 30, 2023

Read This paper explains how synthetic biology is regulated in Europe. A few months ago, one participant in a clinical trial for a CRISPR-based gene therapy for Duchenne muscular dystrophy suddenly died. It’s gonna be used for phase 3 trials of a C. .” Nature Genetics. This review is a good place to start.

Vaccine 52

Vaccine Engineering DNA RNA 52