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The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinicaldevelopment activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinicaldevelopment functions.
Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinicaldevelopment functions.
During clinicaldevelopment, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. We recently published a whitepaper discussing the value of proactive AME studies, best practices, and lessons we’ve learned over the years to help optimize your study.
You can learn more about biomarkers and how to use them in oncology studies in this whitepaper. Optimize Your Oncology Program with Worldwide Matt Cooper and our global team of oncology experts have dedicated their careers to oncology clinicaldevelopment programs.
As a provider of end-to-end clinicaldevelopment 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 clinicaldevelopment to support drug approval and commercialization.
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.
Our PPD FSP solutions help biotech and biopharmaceutical companies meet their timelines by providing top-tier functional expertise that complements existing capabilities and helps companies tackle their unique clinicaldevelopment challenges.
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Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinicaldevelopment. The clinical studies are just a few examples of this critical activity, which emphasizes flexibility and minimizes delays to generate scientifically sound results.”.
The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinicaldevelopment of gene therapy products for rare diseases in February 2023.
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