The Pharma Data

SEPTEMBER 11, 2020

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. Download your copy for solutions and real-life use cases from GSK and the Clinical Trials Transformation Initiative that aim to give patients a voice. Saama Technologies, Inc. ,

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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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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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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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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

JUNE 17, 2024

With FSO, all clinical trial tasks (study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) Increasingly, sponsors are looking for a hybrid approach that combines FSP and FSO models in a bespoke solution that maximizes clinical trial performance. are outsourced to the CRO.

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PPD

DECEMBER 19, 2023

As biotech and biopharma companies seek out the best solutions in increasingly competitive talent markets – and adapt to new demands, priorities and challenges – it’s important to remember that not all FSP/FSO providers are alike. Ready to fuel more efficient drug development?

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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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Codon

APRIL 30, 2023

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. A few months ago, one participant in a clinical trial for a CRISPR-based gene therapy for Duchenne muscular dystrophy suddenly died. vander Straeten et al.

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Codon

APRIL 30, 2023

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. A few months ago, one participant in a clinical trial for a CRISPR-based gene therapy for Duchenne muscular dystrophy suddenly died. vander Straeten et al.

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Agency IQ

FEBRUARY 21, 2024

In sum, the aim of the organization and its stakeholders is to develop an online environment to house everything from clinical trial data to marketing applications, to product labeling, manufacturing changes, and more.

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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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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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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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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. no[r] a marketing product” under Lanham Act). A Florida trial court, in Brookes v. Leading Market Technologies, Inc. , Paragon 28, Inc.

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