Alta Sciences

OCTOBER 28, 2024

White Paper: Whole Genome Sequencing, Proteomics, and Function Characterization of the Sinclair Nanopig™ Discover how the Sinclair Nanopig™ is transforming nonclinical safety assessments. Read the white paper. This fact sheet highlights how our expertise in site selection directly contributes to your clinical trials.

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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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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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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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Conversations in Drug Development Trends

FEBRUARY 21, 2024

We recently published a white paper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study. The post Why Proactive AME Studies are Critical to Accelerating Your Approval Journey appeared first on Worldwide Clinical Trials.

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PPD

OCTOBER 21, 2024

Our white paper on the topic examines reasons biotech companies use the functional service provider (FSP) model to support their clinical development activities and the value that FSP engagements bring to these organizations. With FSO, all tasks for a clinical trial are outsourced. are outsourced.

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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.

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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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Conversations in Drug Development Trends

APRIL 4, 2024

Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research. To take a deeper dive into these guidelines, read our Q&A white paper , where industry-leading experts answer some common questions on bioanalytical guidance.

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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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EG Life Sciences

FEBRUARY 15, 2023

It is without a doubt that 2022 predicted change and opportunity in biopharma and biotech clinical trials in 2023. Thanks for connecting with us, and we invite you to continue checking in to the EG Life Sciences Content Library for additional interesting blogs, white papers, and more.

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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

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.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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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 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. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

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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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Conversations in Drug Development Trends

NOVEMBER 21, 2023

We thought, thousands of drugs haven’t been researched for thousands of other indications, so how can we disrupt the model? Dr. Fajgenbaum was determined to live, so he set out to leverage his limited medical training, scouring existing research literature and studying his body to find a treatment.

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Conversations in Drug Development Trends

AUGUST 14, 2024

Recent Advancements in Biomarker Research The latest advancements in biomarker research have further elevated the biomarker’s role in disease diagnosis, treatment, and monitoring. Check out our white paper to learn more about our services, or contact our team to find out how we can help support your oncology drug development program.

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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. ,

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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.

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Agency IQ

JULY 21, 2023

The assessment of this benefit typically relies upon the use of specific endpoints to measure this clinical benefit, generally within the context of a clinical trial. [ OS is an outcome-related endpoint that is defined as the time from trial randomization until death from any cause in the intent-to-treat population.

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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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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. Nucleic Acids Research. Nucleic Acids Research. ” Nucleic Acids Research. . ” Nucleic Acids Research. PLOS Computational Biology.

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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. Nucleic Acids Research. Nucleic Acids Research. ” Nucleic Acids Research. . ” Nucleic Acids Research. PLOS Computational Biology.

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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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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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