CRO Management: Assay Transfer, Validation, and Testing Oversight
Molecular Interaction Solutions provides expert support for outsourced testing in the pharmaceutical industry on a contract basis, overseeing the entire process to ensure quality and accuracy. We maintain regular communication with external laboratories, guiding assay design and methodology, assisting in the development of transfer protocols, and ensuring smooth knowledge transfer between clients, contract testing organizations (CROs), and Contract Testing Labs (CTLs). We review testing data and associated documentation to confirm that results meet both scientific and regulatory standards. With our oversight and direct support, we ensure that outsourced testing is executed efficiently, delivering reliable and accurate results that align with your project goals.
Assay Design and Transfer Oversight
Guiding Assay Design: We provide direct support in guiding the design of assays to ensure they meet specific research needs and are tailored to project objectives.
Efficient Assay Transfer: We manage the seamless transfer of assays to CROs, ensuring clear communication of protocols, methods, and regulatory requirements.
Assay Validation and Testing Execution
Validation of Assays: Our team oversees the validation of a range of assays, including SPR, ELISA, and others in CROs, ensuring they meet the necessary performance criteria and comply with industry and regulatory standards.
Efficient Assay Transfer: We manage the seamless transfer of assays to CROs, ensuring clear communication of protocols, methods, and regulatory requirements.
Testing Oversight: We directly manage the execution of assays at external laboratories, ensuring testing is completed according to the agreed-upon protocols and timelines. Our hands-on oversight ensures that assays for various stage of drug developments are performed accurately and on schedule.
Data And Document Review
Document Review : We ensure all associated documentation—protocols including transfer and validation protocols, SOPs, and final reports—are thoroughly reviewed for accuracy and consistency.
Data Review & Analysis: We provide comprehensive review and analysis of assay data, including SPR, ELISA, and other assay formats, to ensure that results are reliable, reproducible, and meet the required standards for binding kinetics, affinity, potency, and other key metrics.
Deviation & Investigation Management: If any deviations occur during the transfer or testing process, we oversee the documentation and investigation of these issues, ensuring that they are resolved promptly without compromising quality or compliance.
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