Selecting the right sites for a radiopharmaceuticals clinical trial is crucial for ensuring seamless study startup, enrollment, and execution. Given the radioactive nature of the investigational medicinal product (IMP), it is important for sponsors and contract research organizations (CROs) to design site feasibility questionnaires that confirm sites have the specialized credentials and capabilities needed to...
Selecting the right sites for a clinical trial is one of the most important determinants of successful clinical trial recruitment. In an increasingly competitive clinical trial environment where study designs have become more complex and sites are more selective about the studies they take on, sponsors and CROs are tasked with making the site selection...
Partnering with the right sites is crucial for study success and yet efficient site selection continues to be an industry-wide challenge. As the clinical trial landscape grows more competitive and studies increase in complexity, the process of site selection has become even more challenging. However, by taking a disciplined approach to site selection, sponsors can...
Product development from translation to registration has become increasingly more difficult and costly. Ambitions are high but success rates are low. If development is a tough path, commercialization is even harder. In 2022, the average year one sales per branded product were a mere $65MM. In 2021, 45% of all prescriptions were rejected or blocked....
Developing a new biopharmaceutical product is a lengthy, high-stakes journey. It takes, on average, at least 10 years and more than $2 billion to successfully bring a new drug to market, and only 10 to 15 percent of products ultimately receive regulatory approval. A comprehensive plan and the right regulatory and therapeutic expertise can significantly...
Expert Solutions from Concept to Commercialization Across the development lifecycle, our integrated solutions and cross‑functional team provide customized support for your program—Built for Biotech declares our mission and our mantra. Our all‑encompassing and all‑in perspective blends strategic thinking with hands‑on experience across every aspect of development, helping biotech, specialty pharma, and MedTech innovators turn brilliant...
March 19th, 202411 a.m. EDT Product development from translation to registration has become increasingly more difficult and costly. Ambitions are high but success rates are low. If development is a tough path, commercialization is even harder. In 2022, the average year one sales per branded product were a mere $65MM. In 2021, 45% of all...
Introduction When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying sites where patients were already being diagnosed and treated. To achieve this, the Premier...
Advancements in artificial intelligence, machine learning, and computing technologies have fueled progress in the use of sophisticated computational modeling and simulation as a tool for facilitating preclinical and clinical research in rare diseases. In this white paper, we explore the promise of in silico approaches to rare disease drug development and share real world scenarios...