SOPs for Drug Discovery

The purpose of this Standard Operating Procedure (SOP) is to ensure that all animal testing conducted during preclinical studies complies with global animal testing regulations. This SOP outlines the procedures for adhering to international guidelines such as the OECD Principles of Good Laboratory Practice (GLP), the U.S. FDA regulations, and the European Union regulations for animal welfare and testing. Compliance with these regulations is crucial to ensure ethical standards, data integrity, and acceptance by regulatory authorities.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for preparing and submitting animal study reports. Accurate and comprehensive reporting of animal study data is crucial to meet regulatory requirements, ensure data integrity, and facilitate decision-making. This SOP outlines the process for compiling, reviewing, and submitting reports related to animal studies, ensuring compliance with ethical standards, Good Laboratory Practice (GLP), and regulatory guidelines.
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The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting data review meetings during preclinical studies. These meetings are critical to ensuring that study data is reviewed systematically, any issues are identified promptly, and decisions are made to guide the study towards successful outcomes. This SOP ensures that data review meetings are conducted in a structured, effective, and compliant manner to facilitate data integrity, regulatory compliance, and project success.
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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the preparation of samples for omics-based studies. Omics-based technologies such as genomics, proteomics, metabolomics, and transcriptomics are increasingly used in preclinical research to analyze large-scale biological data. The quality of sample preparation is critical to ensure the accuracy and reliability of results. This SOP outlines the steps to ensure that samples are prepared consistently, following best practices and regulatory guidelines, to maintain data integrity and reproducibility.
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The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for documentation and record-keeping in preclinical studies. Proper documentation and record keeping are essential to ensure compliance with regulatory requirements, maintain data integrity, and support the reproducibility and traceability of study results. This SOP outlines the procedures for managing study documents, ensuring that all records are accurate, complete, secure, and accessible for review or audits.
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The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for identifying, assessing, and managing risks during preclinical studies. Risk management is crucial to mitigate potential issues that could impact the study’s success, including data integrity, regulatory compliance, safety concerns, and resource allocation. This SOP provides a systematic approach for risk identification, evaluation, mitigation, and monitoring throughout the preclinical study lifecycle.
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The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting statistical analysis of data generated during preclinical studies. Statistical analysis is essential for interpreting study results, drawing valid conclusions, and ensuring that data are analyzed in a scientifically rigorous and compliant manner. This SOP ensures that statistical analyses are carried out consistently, accurately, and in compliance with regulatory guidelines, enabling the reliable interpretation of preclinical study outcomes.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for monitoring the progress of preclinical studies. Monitoring the progress of preclinical studies is critical to ensure that they are conducted according to the study protocol, on schedule, and within budget. This SOP outlines the process for tracking the progress of preclinical studies, identifying potential issues early, and taking corrective actions to ensure the study meets its objectives and regulatory requirements.
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The purpose of this Standard Operating Procedure (SOP) is to define the procedures for collaborating with external preclinical testing laboratories. Collaborating with external labs is a common practice in drug development when specialized expertise, resources, or services are required that are not available internally. This SOP ensures that such collaborations are managed effectively, ensuring that all data generated by external labs meet quality standards, regulatory requirements, and project timelines.
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The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for the use of alternative models in preclinical studies. Alternative models are crucial for reducing, refining, and replacing the use of animals in research while still providing scientifically valid data. These models may include in vitro systems, computer models, human-derived cell cultures, and other non-animal testing approaches. This SOP ensures that the use of alternative models is conducted systematically, in compliance with ethical guidelines, and provides data that is reliable for regulatory submissions and safety evaluations.
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