Clinical Research Focus. 18th Edition Clinical Drug Interaction Studies with Combined Oral Contraceptives The FDA has issued a final guidance on “Clinical Drug Interaction Studies with Combined Oral Contraceptives.” The guidance is aimed to help the IND and NDA sponsors evaluate potential interactions between their drugs and oral contraceptives, design respective studies, and communicate its results and risk mitigation strategies Read more
Poland: A Thriving Hub for Biotech Advancements and Clinical Trials Poland has emerged as a leading destination for biotech professionals seeking a dynamic and conducive environment for conducting clinical trials. With its robust healthcare infrastructure, highly skilled workforce, supportive regulatory framework, and favorable economic conditions, Poland offers a compelling landscape for biotech advancements. This article aims to delve into the key factors that have made Read more
Insights from ASCO 2023 Cromos Pharma’s CEO, Vlad Bogin, recently attended the 58th meeting of the American Society of Clinical Oncology (ASCO). Vlad took part in discussions with key opinion leaders about current clinical research trends and held a significant number of meetings with biotech and pharma stakeholders to discuss their development programs. Here are Vlad’s key takeaways from this Read more
Clinical Research Focus. 17th Edition The Pros and Cons of the FDAs Real-Time Oncology Review Program The FDA’s Real-Time Oncology Review (RTOR) is a novel program designed to expedite the review of new cancer therapies. Since its inception the program has gained considerable attention among biotech professionals, especially those working in the field of oncology. Under the RTOR program, the FDA accepts Read more
