Recruiting participants for clinical trials has always been a challenge. Despite the potential benefits of innovative treatments, many studies struggle to enroll enough participants to meet research objectives. One often overlooked factor in this struggle is the complexity of Informed Consent Forms (ICFs). Traditional ICFs are notorious for being long, …
Clinical trials play a crucial role in advancing medical science and ensuring the safety and efficacy of new treatments. However, conducting clinical research involves meticulous documentation to comply with ethical and regulatory standards. One of the most widely recognized frameworks governing clinical trial conduct is the International Council for Harmonisation …
The Investigator’s Brochure (IB) is a cornerstone document in clinical research, serving as a comprehensive compilation of clinical and non-clinical data on an investigational product (IP). Its primary purpose is to provide investigators and other stakeholders with the necessary information to facilitate the safe and effective conduct of a clinical …