SOPs for BA-BE Studies V 2.0

To define a standardized procedure for the creation and use of a Study Initiation Checklist that ensures all regulatory, administrative, logistical, and operational activities are completed prior to the initiation of a Bioavailability/Bioequivalence (BA/BE) clinical study.
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To define the procedure for reviewing and analyzing the product monograph and prescribing information of reference and test products used in Bioavailability/Bioequivalence (BA/BE) studies, in order to ensure clinical relevance, regulatory compliance, and protocol alignment.
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To establish a procedure for reviewing the Summary of Product Characteristics (SmPC) for reference medicinal products used in Bioavailability/Bioequivalence (BA/BE) studies intended for regulatory submission in the European Union (EU).
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To define the procedure for conducting a pre-study kickoff meeting for Bioavailability/Bioequivalence (BA/BE) studies to ensure that all relevant stakeholders are aligned on study objectives, timelines, roles, and responsibilities prior to study initiation.
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To outline the procedure for managing Confidentiality Disclosure Agreements (CDAs) or Non-Disclosure Agreements (NDAs) with clinical study sites in BA/BE studies to ensure that proprietary study information is protected prior to sharing sensitive documents like protocols or clinical trial agreements.
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To define the process for training study personnel on the study protocol and applicable Good Clinical Practice (GCP) guidelines prior to initiation of Bioavailability/Bioequivalence (BA/BE) studies, ensuring subject protection, data integrity, and regulatory compliance.
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To define the procedure for reviewing and documenting the feasibility of recruiting healthy volunteers or study subjects for Bioavailability/Bioequivalence (BA/BE) studies in order to ensure timely completion of enrollment and avoid protocol deviations.
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To define the procedure for preparing and obtaining approval for the clinical trial budget associated with Bioavailability/Bioequivalence (BA/BE) studies, including cost estimation, review, negotiation, finalization, and documentation.
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To define the standardized process for evaluating, qualifying, and approving third-party vendors including bioanalytical labs, logistics providers, and courier services involved in Bioavailability/Bioequivalence (BA/BE) studies.
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To define the procedure for establishing formal Quality Agreements with Contract Research Organizations (CROs) involved in Bioavailability/Bioequivalence (BA/BE) studies to ensure mutual understanding of responsibilities, quality standards, and regulatory compliance.
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