Clinical Research and White Paper - Drug Discovery Digest

Does the Drug Shortage White Paper Fall Short?

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

Drugs FDA Hospitals Government

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

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

Clinical Trials Immune Response Trials Disease

What Sponsors Need to Know About Medicare Coverage Analysis

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

Clinical Research Trials Clinical Trials Research

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

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

Trials Disease Drug Development Clinical Trials

Transformational Relationships: How a Consultative Approach from a CRO Adds Value to Your Development Program

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

Clinical Research Clinical Trials Science Trials

Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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

Clinical Trials Trials FDA Drug Development

How Pharmacogenomics Can Benefit Your Clinical Trial

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

Clinical Trials Trials Compliance Treatment

Informed Design of Bioanalytical PCR Assay Testing Parameters

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

Laboratories Protein Expression Clinical Trials Pharmacokinetics

The Power of Bespoke Hybrid FSP/FSO Solutions

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

Clinical Trials Clinical Development Trials International

Top 10 Drug Discovery Trends at the Top 20 Pharma

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

Biochemical Assays Drugs Small Molecule Pharma Companies

Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs

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

Clinical Trials Trials Drug Development Treatment

Dedicated Roles Keep FSP Projects on Schedule

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

International Research Pharmaceuticals Drug Development

Keeping tabs on Covid-19: BetterLife embraces virtual clinical trials and Novan shares positive results from in vitro antiviral technology against SARS-CoV-2

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

Clinical Trials Trials Pharma Companies Clinical Research

Keeping tabs on Covid-19: Starpharma creates slow release remdesivir nanoparticl…

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

Clinical Trials Pharma Companies Hospitals Trials

The Once and Future FDA Commissioner

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

FDA Pharmaceuticals Pharmaceutical Companies Clinical Research

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

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

Regulations Trials Science Clinical Trials

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

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

Science Regulations International FDA

How the Fifty States View Electronic Data as a “Product”

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

Production International Trials Government

Drug Discovery Digest

Does the Drug Shortage White Paper Fall Short?

Making Informed Decisions in Your Oncology Study: Understanding Biomarkers

Trending Sources

What Sponsors Need to Know About Medicare Coverage Analysis

Considering Master Protocol Use in Your Trial: Evaluating Basket and Umbrella Trial Designs

Transformational Relationships: How a Consultative Approach from a CRO Adds Value to Your Development Program

Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

How Pharmacogenomics Can Benefit Your Clinical Trial

Informed Design of Bioanalytical PCR Assay Testing Parameters

The Power of Bespoke Hybrid FSP/FSO Solutions

Top 10 Drug Discovery Trends at the Top 20 Pharma

Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs

Dedicated Roles Keep FSP Projects on Schedule

Keeping tabs on Covid-19: BetterLife embraces virtual clinical trials and Novan shares positive results from in vitro antiviral technology against SARS-CoV-2

Keeping tabs on Covid-19: Starpharma creates slow release remdesivir nanoparticl…

The Once and Future FDA Commissioner

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

How the Fifty States View Electronic Data as a “Product”

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