Marketing, Regulations, Research and White Paper

Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

OCTOBER 2, 2024

A recent white paper from the PPD™ clinical research business of Thermo Fisher Scientific details how these functions have evolved over the years, moving from capabilities that were previously built up and maintained in-house, to the multiple outsourcing models available today.

Clinical Trials

Clinical Trials Clinical Development Clinical Research Trials

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

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

Regulations Trials Science Clinical Trials

Compliant Science: The Critical Role of Compliance for Medical Affairs

H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

Compliance

Compliance Science Regulations Pharmaceutical Companies

Patient-Centric Strategies for Successful Oncology Trials

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Researchers often employ cell therapy studies for oncology indications, and the U.S. Regulators and payors also demand a higher volume of data collection for these studies.

Trials

Trials Clinical Trials Therapies Drug Development

How to reach a fully integrated production environment by transforming labs

The Pharma Data

SEPTEMBER 9, 2020

In order to capture and manage large amounts of data while conforming to regulations, laboratories need to transform and be digitalized by unifying data capture and providing an intuitive way of interacting with it. Transition to advanced analytics platforms to accelerate a product’s time-to-market.

Production

Production Laboratories Compliance Government

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Agency IQ

JULY 21, 2023

In 2019, the advocacy organization, Friends of Cancer Research (FOCR) organized a multi-stakeholder initiative comprised of industry, government, and academia to find out. In parallel, FOCR developed a white paper that provided an overview of the potential regulatory applications for ctDNA in oncology.

FDA

FDA Clinical Trials Treatment DNA

Expert Interpretation and Analysis of Regulatory Intelligence Are Key to FSP-Delivered Pharmacovigilance

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

Compliance Regulations Production International

Article FDA Thank You FDA holds the line on remanufacturing definitions in newly finalized guidance

Agency IQ

MAY 10, 2024

The new guidance maintains the agency’s existing definitions of remanufacturing and servicing, but adds a new section that provide a high level overview of the medical device regulations – primarily for those “less familiar.” Also this year, the FDA finalized its new rule on overhauling the medical device quality system regulations.

FDA

FDA Regulations Compliance Production

Analysis Life Sciences Thank You CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

Agency IQ

NOVEMBER 10, 2023

However, FDA’s vision for OPQ to serve as a “single, agency-wide quality oversight program that applies a uniform set of standards to all regulated products, and which integrates quality review, evaluation, and inspection activities under one authority” was first publicized more than a decade earlier.

Pharmaceuticals

Pharmaceuticals Small Molecule Science FDA

Codon Digest: Vaccine Printer Go Brrrrr!

Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. 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.

Vaccine

Vaccine Engineering DNA RNA

Codon Digest: Vaccine Printer Go Brrrrr!

Codon

APRIL 30, 2023

This study sheds light on how, exactly, AI-generated text differs from the real stuff, and how it could be used to (soon) write entire research papers. 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.

Vaccine

Vaccine Engineering DNA RNA

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

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Leading Market Technologies, Inc. ,

Production

Production International Trials Government

Drug Discovery Digest

Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

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

Trending Sources

Compliant Science: The Critical Role of Compliance for Medical Affairs

Patient-Centric Strategies for Successful Oncology Trials

How to reach a fully integrated production environment by transforming labs

Article FDA Thank You The next chapter in the ctDNA story: Still promising, not ready for prime time

Expert Interpretation and Analysis of Regulatory Intelligence Are Key to FSP-Delivered Pharmacovigilance

Article FDA Thank You FDA holds the line on remanufacturing definitions in newly finalized guidance

Analysis Life Sciences Thank You CDER’s Office of Pharmaceutical Quality to reorganize, citing need to address ‘pain points’

Codon Digest: Vaccine Printer Go Brrrrr!

Codon Digest: Vaccine Printer Go Brrrrr!

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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