Introduction In the realm of clinical trials, efficient sponsor oversight is imperative for ensuring compliance with regulatory requirements and safeguarding the integrity of the study. This case study delves into the transformative impact of Zenovel on a company’s sponsor oversight, specifically focusing on the enhancement of adverse event management and

Introduction Bioequivalence studies involving highly variable molecules, such as mesalamine, ranolazine, albendazole, and mebendazole, present significant challenges. There are multiple factors to take in consideration while conduct of the study which may contribute high Subject-to-subject variability and finally failures in achieving study objectives. Zenovel, with extensive experience in handling highly

In BA-BE research, many a time investigators use subjective language to describe the symptoms of an Adverse Event or a Side Effect. Frequent use of subjective judgement in the AE severity assessment as well as in the AE reporting is commonly observed. Individual assessment is unlikely to help determine attribution

Background The study protocol required each volunteer to provide a urine sample for Urine Alcohol Testing (UAT) upon Check-In. Only those with a negative UAT result were eligible to enroll in the study. The objective of this case study is to highlight the critical role of monitoring and the implications

The Clinical Research Protocol is the single most crucial document describing the study design, objectives, methodology, scientific background of the molecule, the rationale of the study, guidelines to be followed, statistical considerations, and safety precautions for the ethical conduction of the study. Hence, peer review of the protocol plays a

Fair subject recruitment is now more important than ever with the advent of numerous new CROs and study centres while having the same pool of volunteers. Therefore, it is required to have an integrated, centralized, robust, zero-error, countrywide Human Volunteers Eligibility and Cross Participation Tracking to be followed. It is

Posture is crucial in a clinical study as it influences physiological characteristics. These characteristics interact with critical factors determining the pharmacokinetics of drugs (dissolution, absorption, distribution, metabolism, excretion). Posture affects blood flow which may substantially affect the absorption of drugs with a high first-pass metabolism. In addition, posture also has