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.

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Conversations in Drug Development Trends

MARCH 12, 2024

For a more in-depth look at biomarkers, check out our white paper. These markers can inform treatment response and help reduce patient radiation exposure by reducing the need for repeated imaging assessments in clinical trials. How will your biomarkers be collected, and are the timelines feasible?

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Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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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

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The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

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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. Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs 1.

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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.

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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.

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Clinical Trials Clinical Development Clinical Research Trials 52

Conversations in Drug Development Trends

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Clinical Trials Trials FDA Drug Development 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. , Saama Technologies, Inc. ,

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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.

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PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. DOWNLOAD OUR WHITE PAPER Learn more about how PPD® Laboratory services can enhance your CGT projects.

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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.) This approach enables unbroken continuity of support and resources across clinical trial operations.

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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.

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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 ).

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PPD

NOVEMBER 25, 2024

Clinical trials are critical for advancing medical research and bringing new treatments to market. These trial locations, despite being activated, fail to enroll participants, leading to increased costs, delays and potentially compromised trial outcomes.

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Conversations in Drug Development Trends

APRIL 7, 2025

Solid tumors present a significant challenge to clinical research due to their complex and heterogeneous nature. Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention?

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PPD

NOVEMBER 18, 2024

For example, a biotech developer creating a new antiviral drug could miss a change in one aspect of a regulatory requirement, only to discover at the end of the process that they must restart a clinical trial or resubmit portions of their data.

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PPD

JANUARY 6, 2025

Clinical trials need to move faster. PPD Functional Service Partnership (FSP) Medical Writing solutions experts explored the potential benefits of LLM tools in clinical and regulatory documentation. Sponsors need more efficiency. LLMs assist with information extraction.

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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. A Florida trial court, in Brookes v. Defendant] has not argued, let alone shown, that [plaintiff] cannot prevail under that theory. Jane Doe No.

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