PPD

MARCH 21, 2024

When participating in clinical trials, pediatric populations require distinct considerations for their safety and well-being — which can present unique challenges for drug developers. Ready for more insights into putting the child at the heart of your pediatric clinical trial?

Clinical Trials 52

Clinical Trials Trials Drug Development Treatment 52

The Pharma Data

SEPTEMBER 11, 2020

Starpharma experimenting with Gilead’s antiviral drug for easier administration. Melbourne-based Starpharma has announced it has applied its novel DEP drug delivery technology to create a long ? Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease.

Clinical Trials 52

Clinical Trials Pharma Companies Hospitals Trials 52

The Pharma Data

OCTOBER 16, 2020

With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely. BetterLife conducts patient centric study via a fully remote clinical trial. All of these technologies can be used on a variety of devices.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Clinical Research 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. At a February 2024 joint workshop with the U.S.

Regulations 40

Regulations Trials Science Clinical Trials 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. This research ultimately influenced the creation of a new submission process for the client.

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Compliance Regulations Production International 52

Conversations in Drug Development Trends

MARCH 1, 2024

To help determine if a master protocol could be a good fit for your study, check out this white paper for a more comprehensive overview of the appropriateness of master protocols in different contexts. Here are some relevant factors below: What Are the Advantages of a Master Protocol? Contact us.

Trials 78

Trials Disease Drug Development Clinical Trials 78

PPD

DECEMBER 19, 2023

According to industry figures, the use of FSP models grew from 28% to 41% in just three years (2018-2021); by 2022, our internal research shows that nearly two-thirds of outsourcing budgets were allocated to FSP or hybrid FSP/FSO models. Ready to fuel more efficient drug development?

International 52

International Research Pharmaceuticals Drug Development 52

PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. This requires an expert RA team capable of processing large volumes of routine submissions to support any changes to manufacturing, market expansion, or safety and quality reporting — for every drug or device in the company’s portfolio.

Compliance 52

Compliance Production Clinical Research Marketing 52

PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

Agency IQ

FEBRUARY 21, 2024

In essence, it consists of five modules: 1) Region-specific information (essentially administrative/process-related documentation), 2) Application summary, 3) Quality information, 4) Nonclinical information, and 5) Clinical information. The format and organization of the CTD is outlined in the ICH M4 Guideline. CMS in the United States ).

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. Smith rejected plaintiff’s analogy between books and drug package inserts. Demuth Development Corp. Merck & Co. , 990 (E.D.N.Y. Libertelli v.

Production 52

Production International Trials Government 52