Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. Based on previous studies, a single marker may be insufficient, and therefore, research points to the need for a “composite biomarker” made up of multiple markers meaningfully combined to inform the current disease state.

Clinical Trials 72

Clinical Trials Immune Response Trials Disease 72

Conversations in Drug Development Trends

MARCH 1, 2023

The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. See how to unlock the full power of your CRO partner in our white paper, Optimal Outcomes in Clinical Research and Product Development.

Clinical Research 52

Clinical Research Clinical Trials Science Trials 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

Conversations in Drug Development Trends

MARCH 7, 2024

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

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.

Compliance 52

Compliance Regulations Production International 52

PPD

AUGUST 28, 2024

Researchers often employ cell therapy studies for oncology indications, and the U.S. A seasoned provider of contract research organization (CRO) solutions will infuse hybrid and decentralized solutions into studies, with experts that provide the breadth and depth of experience required to deploy mobile sites, wearables and more.

Trials 64

Trials Clinical Trials Therapies Drug Development 64

PPD

OCTOBER 12, 2023

Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance. In this uncharted landscape, it is critical that clinical trial teams possess familiarity with past regulatory guidance as well as new technologies and methods for reducing regulatory risks.

Laboratories 52

Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

Conversations in Drug Development Trends

MARCH 20, 2024

To learn more about these various genes and how they can affect your clinical trial participants, as well as to understand the full extent of the power of pharmacogenomics, check out our white paper. The post How Pharmacogenomics Can Benefit Your Clinical Trial appeared first on Worldwide Clinical Trials.

Clinical Trials 52

Clinical Trials Trials Treatment Compliance 52

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. Read our white paper to learn the keys to successfully implementing functional service partnerships.

International 52

International Research Drug Development Pharmaceuticals 52

The Pharma Data

SEPTEMBER 11, 2020

Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease. The Covid-19 command center was created to provide sponsors of clinical trials pursuing in-house Covid-19 research with an AI-powered data analytics platform. Saama Technologies, Inc. ,

Clinical Trials 52

Clinical Trials Pharma Companies Trials Hospitals 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. Source link.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Clinical Research 52

PerkinElmer

FEBRUARY 18, 2021

A PerkinElmer White Paper offers a detailed look at the findings. Top 10 trends in pre-clinical drug discovery at top 20 Pharma 1. These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. Small molecules are making a comeback.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

PPD

JULY 9, 2024

A unique flex hub model that delivers global solutions at scale At the PPD clinical research business of Thermo Fisher Scientific , a typical FSP RA engagement designates a single team to provide oversight across a client’s many products and throughout all their markets. Let’s connect.

Compliance 52

Compliance Production Clinical Research Marketing 52

PPD

MARCH 21, 2024

Partnering with a contract research organization (CRO) that has deep experience in pediatric clinical trials enables drug developers to successfully implement these strategies, which also have the potential to enhance study startup time, ease the burden on pediatric patients and their caregivers, and ultimately improve retention rates.

Clinical Trials 52

Clinical Trials Trials Drug Development Treatment 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

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 Clinical Trials Science 40

Eye on FDA

NOVEMBER 18, 2021

Media coverage regarding the nomination has been largely focused on concerns expressed by some about Dr. Califf’s past work with pharmaceutical companies in clinical research. Secondly, one actually wants someone who knows research and understands the industry to be the head of FDA.

FDA 57

FDA Pharmaceuticals Pharmaceutical Companies Clinical Research 57

Agency IQ

FEBRUARY 21, 2024

Given the widespread use of CDISC for clinical research and HL7 for electronic health record (EHR) data, the two organizations have partnered to create mapping guides to streamline the flow of data from EHRs to CDISC submission-ready datasets, and vice versa. 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. From these exercises we concluded that a 50-state survey on intangibles as “products” for product liability purposes would be both doable and useful.

Production 52

Production International Trials Government 52