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.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. 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.

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Clinical Trials Pharmacy Clinical Pharmacology FDA 80

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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Clinical Trials Trials FDA Drug Development 52

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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Therapies Engineering Production FDA 59

Conversations in Drug Development Trends

JULY 29, 2024

Clinical development programs must acknowledge the complexity and variability of obesity as a condition. 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.

Clinical Research 52

Clinical Research Research Clinical Trials Treatment 52

Conversations in Drug Development Trends

NOVEMBER 21, 2023

As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.

Disease 78

Disease Treatment Clinical Trials Clinical Development 78

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.) across protocols, medicinal products, a portfolio of studies or the entire company.

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Clinical Trials Clinical Development Trials International 52