Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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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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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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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

NOVEMBER 21, 2023

In partnership with our experts, Every Cure will prioritize the list by considering unmet medical need, drug accessibility, disease severity, and other relevant factors. The post How Worldwide and Every Cure Are Using AI To Unlock New Rare Disease Treatments appeared first on Worldwide Clinical Trials.

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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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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. Often our clients are keen to retain oversight and control, even as they take advantage of FSP models.

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Conversations in Drug Development Trends

AUGUST 14, 2024

However, at Worldwide, we have a proven track record of successfully utilizing biomarkers in oncology development. 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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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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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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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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PPD

DECEMBER 19, 2023

Ready to fuel more efficient drug development? Read our white paper to learn the keys to successfully implementing functional service partnerships. LEARN MORE The post Dedicated Roles Keep FSP Projects on Schedule appeared first on PPD Inc.

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PPD

NOVEMBER 25, 2024

Clinical trials are critical for advancing medical research and bringing new treatments to market. However, a significant challenge drug developers face is that of non-enrolling sites. This allows sponsors to make timely adjustments to their strategies, ensuring sustained improvements in site performance throughout the trial.

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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. Issue 41 of The Altascientist focuses on bioanalytical testing for immunomodulatory drugs. Watch it now.

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Conversations in Drug Development Trends

APRIL 7, 2025

Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention? Integrate Biomarkers Where Possible Biomarker integration is crucial in solid tumor clinical trials, though more research is needed before fully validated assays become the norm across solid tumor indications.

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