PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions.

International 87

International Clinical Development Clinical Trials Clinical Research 87

Advarra

MAY 26, 2023

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.

Clinical Research 52

Clinical Research Trials Clinical Trials Research 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

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.

Compliance 98

Compliance Regulations Production Trials 98

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

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.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 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. Oncology is the top therapeutic area of interest, today and tomorrow.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 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

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

AUGUST 28, 2024

The PPD clinical research business of Thermo Fisher Scientific’s expert teams have conducted over 160 immuno-oncology studies, more than 137 CGT studies and 263 early phase oncology studies, covering a wide range of tumor types and therapies. Enable every aspect of your complex oncology trial.

Trials 69

Trials Clinical Trials Drug Development Therapies 69

PPD

OCTOBER 12, 2023

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. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.

Laboratories 52

Laboratories Clinical Trials Protein Expression 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 Drug Development 52

PPD

DECEMBER 19, 2023

Read our white paper to learn the keys to successfully implementing functional service partnerships. Ready to fuel more efficient drug development? LEARN MORE The post Dedicated Roles Keep FSP Projects on Schedule appeared first on PPD Inc.

International 52

International Research Drug Development Pharmaceuticals 52

PPD

MARCH 21, 2024

A Wealth of Pediatric Clinical Trial Experience When enacting strategies to tailor pediatric clinical trials to the child’s needs, experience matters. The PPD clinical research business of Thermo Fisher Scientific has demonstrated its expertise in taking extraordinary measures to improve the lives of pediatric patients.

Clinical Trials 52

Clinical Trials Trials Drug Development Treatment 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

JUNE 17, 2024

Discover the many ways a hybrid outsourcing model that integrates our PPD FSP solutions into your new or existing FSO arrangement helps ensure the on-time, on-budget success of your clinical trials. Download our white paper The post The Power of Bespoke Hybrid FSP/FSO Solutions appeared first on PPD.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

Agency IQ

APRIL 12, 2024

ACRO’s white paper also highlights the potential for “enhanced efficiency, long-term cost savings, and faster collection of data” through risk-based monitoring and other data collection efficiencies.

Regulations 40

Regulations Trials Clinical Trials Science 40

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

FDA Law Blog: Biosimilars

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Drugs 59

Drugs FDA Hospitals Government 59

Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. The IO biomarker field is rapidly evolving—check out this white paper for the latest details regarding IO biomarkers. Below, we discuss some validated circulating oncology biomarkers, their implementation, and key operational considerations.

Clinical Trials 72

Clinical Trials Immune Response Trials Disease 72

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. Though, of course, it is a very different political climate and a different Senate than it was the first time.

FDA 57

FDA Pharmaceuticals Pharmaceutical Companies Clinical Research 57

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 is customized to meet immediate needs related to research on the novel coronavirus, but can also be used more broadly for other infectious disease clinical development efforts now and in the future.”.

Clinical Trials 52

Clinical Trials Pharma Companies Trials Hospitals 52

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 Trials International Government 52

PPD

NOVEMBER 25, 2024

Our expertise leads to your trial’s success The PPD clinical research business of Thermo Fisher Scientific has a proven track record and expertise in leveraging machine learning and other cutting-edge technologies for managing sites. Ready to gain more insights into the impacts of innovative strategies like machine learning?

Clinical Trials 98

Clinical Trials Trials Clinical Research Drug Development 98

PPD

NOVEMBER 18, 2024

There are many nuances to ensuring that the RI gathered and monitored is as effective as possible (as discussed in our recent white paper on the topic). Download our white paper The post Leveraging FSP Solutions and Expertise to Keep Up With Regulatory Intelligence Systems Monitoring appeared first on PPD.

Clinical Trials 52

Clinical Trials Regulations Compliance Production 52

PPD

JANUARY 6, 2025

For example, LLMs can efficiently summarize the content of clinical protocols or Investigators Brochures facilitating a more efficient writing process. LLMs are a useful tool for extracting dense information contained in white papers or info-rich tables, such as a schedule of assessments. LLMs assist with information extraction.

Clinical Research 52

Clinical Research Clinical Trials Compliance Engineering 52