PUBLICATIONS

Regulatory Focus Shifts: Expanding Role of Real-World Evidence for Evaluating New and Expanded Drug Indications In the ever-evolving landscape of healthcare, real-world evidence (RWE) is attracting growing interest from regulators as a valuable source of information for evaluating new and expanded drug indications. RWE refers to data collected from healthcare claims, registries, electronic health records and even non-traditional sources like mobile phones, consumer devices, and various tools used for telehealth. Read more

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