Fierce BioTech

JANUARY 26, 2024

Blueprint for Modern Patient Recruitment Every day, a clinical trial is delayed due to recruitment planning issues. Discover how leading sponsors are redefining the approach to patient recruitment in clinical trials. mahart Fri, 01/26/2024 - 14:53 Every day, a clinical trial is delayed due to recruitment planning issues.

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The Pharma Data

SEPTEMBER 1, 2020

Explore how emerging trends in clinical trial investigations are bringing patients closer to medicine making them more patient-centric. The patient experience is an important consideration in trial design. Download your copy today to find out how to digitally transform your clinical trials. Download Your Copy.

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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 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

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

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

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.

Clinical Research 52

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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

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” You can learn more about biomarkers and how to use them in oncology studies in this white paper.

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Conversations in Drug Development Trends

APRIL 4, 2024

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. The post Demystifying the ICH M10 Bioanalytical Method Validation Guidelines appeared first on Worldwide Clinical Trials.

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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

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. Dr. Francis S.

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Conversations in Drug Development Trends

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. These data emphasize the need for precise and meaningful body composition endpoints in T2D and obesity clinical trials.

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Clinical Research Research Clinical Trials Treatment 52

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.

Compliance 52

Compliance Regulations Production 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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Laboratories Protein Expression Clinical Trials Pharmacokinetics 52

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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Clinical Trials Clinical Development Trials International 52

Conversations in Drug Development Trends

MARCH 1, 2023

Sustaining a strategic approach during the turmoil of joining two companies has proven difficult, and many sponsors have felt the impact of the fallout from such a union on their trial. 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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Clinical Research Clinical Trials Science Trials 52

The Pharma Data

NOVEMBER 26, 2020

The uncertainty raised by the Covid-19 pandemic has forced the pharma industry to turn its resources toward strengthening clinical trial supply chains and improving patient access to care. For further information on how we process and monitor your personal data, and information about your privacy and opt-out rights, click here.

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Conversations in Drug Development Trends

NOVEMBER 21, 2023

Worldwide will then run the clinical trials for the repurposed assets, leveraging our extensive clinical trial experience and relationships with thousands of sites and clinical experts all over the world.

Disease 78

Disease Treatment Clinical Trials Clinical Development 78

Conversations in Drug Development Trends

AUGUST 14, 2024

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. The post The Role of Oncology Biomarkers in Personalizing Hematology Treatment Plans appeared first on Worldwide Clinical Trials.

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Treatment Therapies Disease Protein Expression 78

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.

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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.

International 52

International Research Drug Development Pharmaceuticals 52

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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The Pharma Data

DECEMBER 8, 2020

. Almost 98 per cent of respondents surveyed for The Veeva 2020 unified clinical operations survey report revealed they needed to unify clinical applications to increase efficiency, quality and speed in clinical trials. . Achieve real-time, end-to-end visibility and oversight of clinical trial processes.

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Science Clinical Trials Compliance Trials 52

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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Regulations Trials Clinical Trials Science 40

Codon

APRIL 30, 2023

A few months ago, one participant in a clinical trial for a CRISPR-based gene therapy for Duchenne muscular dystrophy suddenly died. It’s gonna be used for phase 3 trials of a C. Note: I’m employed by the company and a co-author on the paper.) Read (Also see a summary on Twitter by one of the authors.)

Vaccine 52

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Codon

APRIL 30, 2023

A few months ago, one participant in a clinical trial for a CRISPR-based gene therapy for Duchenne muscular dystrophy suddenly died. It’s gonna be used for phase 3 trials of a C. Note: I’m employed by the company and a co-author on the paper.) Read (Also see a summary on Twitter by one of the authors.)

Vaccine 52

Vaccine DNA Engineering RNA 52

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.

Science 40

Science Regulations International FDA 40

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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