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How Clinical Trial Software Helps Make Studies More Efficient

Clinical trials play a crucial role in advancing medical research and improving patient outcomes. The effectiveness of studies relies heavily on cutting-edge technology to optimize and accelerate the study build and submission processes.   In this blog, we look at some of the innovative software solutions revolutionizing the way researchers design, manage, and analyze trials. Armed … Continued

Dose Optimization Considerations for Targeted Radiation Therapies

The acquisitions of targeted radiation therapy companies (TRT) Point Biopharma by Eli Lilly and RayzeBio by Bristol Meyer Squibb have sparked investors’ interest in this therapeutic class. A growing number of companies are now developing TRTs, and GlobalData reports that venture capital deals in the field have grown 550% to $408 million in 2023.1 The … Continued

AIFA makeover: Italy’s leap into 2024

In a long-awaited development, Italy’s Medicines Agency, AIFA, underwent transformative changes on January 30th, 2024. This has been a recurrent topic of discussion, with talks of merging the Scientific Technical Advisory Committee (CTS) and the Price and Reimbursement Committee (CPR). However, the COVID-19 pandemic delayed these plans, leading to a continuous extension of the current … Continued

Understanding the Role of Your Discovery Asset’s Target Product Profile

If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly if your development program has a single asset. Unfortunately, navigating the ocean of opportunity can become more of a pain than a blessing, especially when your disease area has significant investor activity. Focusing your excitement is essential! It’s beneficial to … Continued

Answers to Drug Developers’ Frequent Electronic Common Technical Document Questions

Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using … Continued

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