Advarra

MARCH 14, 2023

AMCs and Health Systems Integrating a clinical trial management system (CTMS) enables the regulatory team to pull protocol details and place them into eReg. With this integration, staff won’t have to log into the IRB system, download the documents from that system, and re-upload them into eReg.

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Alta Sciences

APRIL 17, 2024

Planning a First-In-Human Clinical Trial? blussier Wed, 04/17/2024 - 20:52 HTML Unique FIH Solutions for Small and Large Molecules Advancing your molecule to first-in-human (FIH) clinical trials is a major milestone. DOWNLOAD Speak with one of our experts. Access the eBook here to learn more.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

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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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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

SEPTEMBER 27, 2023

The PPD clinical research business of Thermo Fisher Scientific has surveyed more than 150 drug developers around the globe to gather annual data on trends in pharmaceutical research and development. Directors, compared to vice president or C-suite respondents, were more likely to report trial complexity as the top challenge.

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The Pharma Data

JANUARY 12, 2021

a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor.

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Conversations in Drug Development Trends

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. The post Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations appeared first on Worldwide Clinical Trials.

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PPD

JUNE 13, 2023

Clinical trials for COVID-19 vaccines changed how all vaccine trials are conducted. DOWNLOAD OUR GUIDE The post Seven Strategies to Avoid Common Pitfalls in Vaccine Development appeared first on PPD Inc. This increase in activity means the vaccine space will be fiercely competitive in the coming years.

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Vaccine Clinical Trials Clinical Research Trials 52

PPD

JULY 16, 2024

Throughout this tremendous growth, our FSP PV team provided regulatory intelligence updates and proactive guidance on the requirements of new countries onboarding for clinical trials and post-approval expansion.

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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

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Conversely, large companies reported nearly the exact opposite, with 48% saying trial timelines are shortening.

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PPD

JULY 13, 2023

Site and patient recruitment vendors are vital in supporting clinical trial operations across all phases and therapeutic areas. Their services help engage a suitable participant pool, facilitate clinical trial participation, ensure that selected sites have the resources to support clinical trial activities and more.

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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

Advarra

MAY 25, 2022

Compliant, efficient document management during the various phases of a clinical trial is essential. As clinical research continues to move towards a remote environment, centralizing and integrating your regulatory management process and technology is vital to your institution’s success. Current eReg Integrations.

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The Pharma Data

JANUARY 27, 2021

“Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular. View original content to download multimedia: [link]. VERONA, Italy , Jan. ” About CROMSOURCE. For more information, visit www.cromsource.com. Source link.

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The Pharma Data

JANUARY 6, 2021

With the IND approval, UNION is granted permission to advance oral orismilast into Phase 2b trials in humans with moderate to severe plaque psoriasis to evaluate the safety and efficacy of orismilast. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

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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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Clinical Trials Clinical Development Trials International 52

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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The Pharma Data

JANUARY 22, 2021

” The approval of voclosporin is based on data taken from two positive pivotal trials — the AURORA Phase 3 study and the AURA-LV Phase 2 study. Among the more than 40 funded research grants focused specifically on lupus nephritis, many have laid the groundwork for critical advances in therapeutic development.

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The Pharma Data

DECEMBER 2, 2020

Research funding is being provided by a grant from Eli Lilly and Company. Lilly is honored to support this research because it is critical in furthering our efforts to improve treatment options for people living with metastatic breast cancer.” View original content to download multimedia: [link].

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The Pharma Data

DECEMBER 16, 2020

Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. This is the most extensive controlled phase 3 study in active lupus nephritis, demonstrating that Benlysta could make a clinically meaningful improvement.

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Alta Sciences

DECEMBER 31, 2024

One of the most important factors to consider during the course of your early-phase clinical research is drug-drug interactions (DDIs), which occurs when one drug alters the effect of another, either by reducing its effectiveness or elevating systemic concentrations to potentially dangerous levelsultimately causing side effects.

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The Pharma Data

NOVEMBER 10, 2020

The therapy has also been included in Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial version 7 and 8), and Diagnosis and Treatment Protocol for Severe and Critical Cases of Novel Coronavirus Pneumonia (Trial version 3), released by National Health Commission & State Administration of Traditional Chinese Medicine.

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Hospitals Clinical Trials Treatment Therapies 52

The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. STOCKHOLM , Dec. In addition, tablets and/or insulin can be required.

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Agency IQ

APRIL 8, 2024

In 2012, the passage of the FDA Safety and Innovation Act (FDASIA) created a new requirement for sponsors to submit all drug submissions, including clinical trial applications, in an electronic format as specified by FDA guidance. This was an area that FDA investigators recently interviewed by the U.S.

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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. , Saama Technologies, Inc. ,

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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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PPD

NOVEMBER 4, 2024

The PPD clinical research business of Thermo Fisher Scientific has conducted a comprehensive survey involving 150 drug developers from around the world. This year’s findings reveal a nuanced landscape where rising clinical trial costs, complex protocol designs and patient recruitment issues have emerged as significant challenges.

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PPD

JANUARY 21, 2025

This decrease brings into sharp focus the growing challenges facing the field: Clinical trials now demand greater complexity, as well as increased data and diversity requirements. Trend 1: Scenario modeling will allow companies to evaluate entire trial timelines, revealing potential bottlenecks that help them achieve optimal outcomes.

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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

MARCH 19, 2025

Bespoke solutions are critical for successful drug development because each clinical research project has unique goals and challenges. Download the 2025 FSP Trends report The post Successfully Implementing an FSP Partnership in Todays Clinical Development Landscape appeared first on PPD.

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The Pharma Data

MAY 13, 2021

Replace some of those empty calories with whole foods and you’ll feel fuller sooner and be less likely to overeat… *This program will be delivered to you by instant download as interactive eBook and audio program. based weight loss intervention in adults with obesity: A randomized clinical trial. Effects of a mindfulness?based

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Drug & Device Law

JULY 31, 2023

mentioned with approval an unappealed trial court ruling that, as to “strict liability,” a cellphone “app was not a product, and thus a products liability theory of recovery was not legally viable.” A Florida trial court, in Brookes v. [Defendant] has not argued, let alone shown, that [plaintiff] cannot prevail under that theory.

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