SIGNIFICANCE OF PEER REVIEW OF CLINICAL STUDY PROTOCOL 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 consideration, and safety precautions for ethical conduction of the study. Hence, peer review of the protocol plays… Continue reading SIGNIFICANCE OF PEER REVIEW OF CLINICAL STUDY PROTOCOL
SIGNIFICANCE OF POSTURE IN PHARMACOKINETIC CLINICAL STUDY 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… Continue reading SIGNIFICANCE OF POSTURE IN PHARMACOKINETIC CLINICAL STUDY
Adverse Event Assessment 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 for common… Continue reading Adverse Event Assessment
Significance of Centralized Cross-Participation Verification In Clinical Research 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 integrated, Centralized, robust, zero error, countrywide Human Volunteers Eligibility and Cross Participation Tracking to be… Continue reading Significance of Centralized Cross-Participation Verification In Clinical Research
