BE Study Monitoring

BE Study Monitoring (Clinical Phase, Bioanalytical Phase & Data Management).

Auditing/monitoring all study related activities to ensure that the study is conducted, and the data are recorded, analyzed, and accurately reported according to the protocol, sponsor’s Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP) and the applicable guidelines and regulatory requirements.

According to our SOPs, our experienced monitors perform the monitoring activities using carefully designed checklists to assess the following:

• The adherence to all aspects of GCP, GLP and GDP during the study.
• All documentations and quality system that is applied by the CRO to ensure plausibility, integrity and consistency of data.
• Presence of any observations, which may raise concerns about the quality or validity of the subject-related data, e.g. laboratory tests; sampling time recording; inclusion and exclusion criteria; adverse event frequencies and severities (profiles) not consistent with the known profile for the product; deviations from dosing regimens, adherence to dietary and exercise restrictions (where applicable)…..etc.
• Presence of any observations which raise concerns about the quality or validity of the sampling process or study sample analyses, e.g.: inconsistencies between the numbers of samples collected, analyzed and reported; insufficient information to confirm the integrity of the samples (e.g. regarding storage and stability); management of repeated sample analyses and missing samples is not described adequately; large number of samples re-assay…. Etc.
• Presence of any observations which raise concerns about the quality or validity of the analytical method e.g.: bioanalytical method has not been fully validated before study sample analyses; the method validation data and the acceptance criteria are inadequate; the data presented are inconsistent with the described and planned methodologies……etc.
• Presence of any observations which raise concerns about the quality or validity of the study in general, e.g. the amount of missing values/drop outs not meet the expectation; absence of relevant SOPs; doubts on the compliance with current requirements and guidelines; implausibility/inconsistency of clinical or analytical data; absence of powerful QA system…. etc.
• Review of CRF and assess data integrity and source document management.
• Review records and procedures concerning interactions with the IRB.
• Review records and procedures concerning Investigational Drug products (IDP) receiving, storage, dispensing and accountability.
• Review records and procedures concerning interactions with AE reporting