Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

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PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

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PPD

DECEMBER 5, 2023

By doing so, companies can augment their ongoing clinical research and sidestep the challenges of global extension, such as language barriers and compliance concerns, without the need to manage the in-country presence themselves. This facilitates smooth, on-schedule operations, de-risking the pipeline.

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Conversations in Drug Development Trends

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Our core areas of research are: Immunology.

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Vial

MARCH 27, 2024

Sponsors must also be cognizant of additional costs associated with more rigorous services such as data management and analysis, maintaining regulatory compliance, and providing individual site monitoring. Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials.

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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. As we look towards future developments in oncology and beyond, the importance of strategic regulatory planning and execution cannot be overstated.

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Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. Improving Communication Between FDA and Sponsors.

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PerkinElmer

JANUARY 25, 2023

These same challenges and needs also extend from research and discovery to clinical development. This also dovetails with the core need to meet the rigors of compliance and audit trails to help support safety for patients.” The emerging field of metagenomics in clinical research settings also shows promise.

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Molecule Blog

MARCH 17, 2023

This phase is typically executed by private biotech labs and/or contract research organizations, funded by venture capital and/or pharma balance sheets. Once an experimental medicine has undergone all clinical development phases, the company files a new drug application ( NDA  — or MAA ), which can be approved or denied by the FDA (or EMA).

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The Pharma Data

NOVEMBER 10, 2020

However, severe toxicities and poor patient compliance limit the long-term use for intravenous immunotherapies. Additionally, oral capsules provide the convenience of home use, and increase patient compliance by eliminating the need for infusions in a clinic or hospital setting. NEW YORK and LONDON, Nov.

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Agency IQ

APRIL 8, 2024

This week, the FDA announced it is finally ready to start accepting adverse event submissions in ICH E2B(R3) format and that the countdown to mandatory compliance with these requirements has begun. Sponsors will have 24 months to get comfortable submitting IND safety reports in E2B(R3) format before compliance becomes mandatory in April 2026.

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PPD

NOVEMBER 8, 2022

PPD, Thermo Fisher Scientific’s clinical research business, surveyed more than 150 biotech and biopharma leaders this year to assess trends in the drug development industry, yielding data we’ll cite throughout this blog.

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Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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