PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Many of these patients’ conditions are disabling.

Trials 64

Trials Clinical Trials Therapies Drug Development 64

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

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 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 Treatment DNA 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

If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans. Read This paper explains how synthetic biology is regulated in Europe. It’s gonna be used for phase 3 trials of a C. Synthetic Biology.

Vaccine 52

Vaccine Engineering DNA RNA 52

Codon

APRIL 30, 2023

If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans. Read This paper explains how synthetic biology is regulated in Europe. It’s gonna be used for phase 3 trials of a C. Synthetic Biology.

Vaccine 52

Vaccine Engineering DNA RNA 52