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
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SIGNIFICANCE OF POSTURE IN PHARMACOKINETIC CLINICAL STUDY
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
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
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
GCP Compliance in Clinical Research
GCP Compliance in Clinical Research We all know very well what GCP truly means in clinical research accurate and credible data plus rights, Integrity, and confidentiality of trial subjects. i.e., “Quality Data + Ethics= GCP” So, what GCP should lead………………” Patient rights, Safety, and Well-being” We certainly always talk about GCP compliance during… Continue reading GCP Compliance in Clinical Research
Importance and Purpose of Clinical Research Monitoring
Introduction: There is no doubt that medical science is reaching new heights every day. All processes related to FDA approval are becoming more advanced, systematic, and quick. The same is true for clinical trial monitoring – a critical activity in drug development and marketing approval to ensure the quality of the research data and the protection of… Continue reading Importance and Purpose of Clinical Research Monitoring