Medical Monitor in Clinical Trials: Essential Roles & Best Practices
An Expert Perspective on Medical Monitor in Clinical Trials In the realm of clinical development, patient safety and efficiency are of utmost importance. A medical monitor in clinical trials plays a pivotal role across the clinical trial, starting from designing the study until clinical study report. Ongoing review of data by medical monitors in clinical […]
Clinical Trials in Oncology: Planning and Conducting Multi-Regional Clinical Trials
Overview In September 2024, the U.S. Food and Drug Administration (FDA) introduced a pivotal guidance document titled “Considerations for Generating Clinical Evidence from (MRCTs) Multi-Regional Clinical Trials in Oncology.” This guidance serves as a comprehensive roadmap for optimizing drug dosages in oncology trials and outlines strategies for effectively planning, designing, and executing MRCTs in cancer […]
US FDA Guidance on Dose Optimization for Oncology Drugs -Clinical Pharmacokinetic considerations
Overview: The FDA guidance on dose optimization for oncology drugs has introduced a pivotal framework aimed at refining dose selection in cancer treatments. This guidance emphasizes the importance of clinical pharmacokinetics (PK), population PK analysis, and dose-response relationships to ensure the efficacy and safety of oncology drugs. Importance of Clinical Pharmacokinetics in Dose Selection Clinical […]
Clinexel Appoints Dr. Mukesh Kumar as Chief Scientific Officer
In a significant move to reinforce its leadership team, Clinexel, a full-service Clinical Research Organization (CRO), has appointed Dr. Mukesh Kumar as its Chief Scientific Officer (CSO). With extensive experience leading Clinical Research & Development (RnD) in global pharmaceutical giants such as Sanofi and Daiichi Sankyo, as well as Indian pharmaceutical leaders like Cipla, Dr. […]