The Oncology Center of Excellence (OCE) Real-time Oncology review (RTOR) Pilot program was initiated in February 2018, specifically for supplemental oncology new drug applications (NDA)s and biologic license applications (BLAs) of previously approved drug products....

Since 2018 when the US Food & Drug Administration (FDA) first published a real-world evidence (RWE) program framework, there has been a clear trend toward pharmaceutical companies utilizing real-world data (RWD) as RWE to support regulatory objectives. While the...

Peer-reviewed journal articles hold a level of importance to the scientific community that cannot be understated. The pharmaceutical industry and healthcare sector, in general, play a pivotal role in maintaining people’s well‑being and improving their quality of life....

Many of the important decisions that sponsors must make during the drug development lifecycle are based on informed benefit-risk assessments. With the assessments serving a critical role, it is imperative that sponsors understand methodologies and considerations of...

Clinical trials play a pivotal role in advancing medical knowledge, evaluating the safety and efficacy of various medical products. However, achieving diversity among clinical trial participants remains a challenge, especially with underrepresentation of certain...

Clinical trial deferrals are a growing topic among those in the transparency niche of the pharmaceutical industry, especially as all new and ongoing clinical trials within the European Union (EU) must now be uploaded to the Clinical Trial Information System (CTIS)...

Recently, there has been a shift in the lexicon for psychedelics in drug development and US Food and Drug Administration (FDA) labelling guidelines. Prescribing information requires precise, accurate descriptions of essential product information to inform healthcare...

The systematic study of psychedelics in drug development programs is a relatively recent phenomenon with psychedelics currently under evaluation in clinical trials for the treatment of anxiety, depression, bipolar disorder, epilepsy, obesity, and substance addiction....

The PowerBI Dashboard has become the signature tool for clinical data analysis, and the growing dependence on PowerBI’s automated visualization tools has led to the need of dashboard validation. Clinical dashboards are built by ingesting raw data and transforming that...