The successful transfer of analytical methods to CRO’s in a timely manner is vital to meet study requirements and key regulatory submission dates. The complexities in the execution of the field, analytical and reporting phases of any study can put added pressures on meeting these dates successfully. It is helpful to keep in mind a few important steps that can assist in a successful transfer of analytical methodologies. Beginning the method verification as soon as possible may seem elementary but the importance of having adequate time allotted cannot be understated. It is typical that there are complications when implementing a method, being able to investigate and mitigate these is critical. Frequent and detailed communication between the sponsor and the CRO is also vitally important in the transfer process. The sponsor will likely have more knowledge of the method intricacies as it is likely that is where it was developed. It is often the case that the method author may be available to the CRO to discuss results, investigate causes and determine the next steps. In these discussions, it is important to include areas of the method that require additional attention and any nuances in the performance of the method that may be important for effective implementation. Setting clear and realistic milestones can also be helpful during the transfer process. This approach can provide an organized process that may aid in identifying issues as steps are completed as well as provide a quick overview of the progress. A collaborative effort during the methods transfer process can be the key to the success of the analytical phase and ultimately meeting submission requirements.

Key elements of successful method transfers

2019 Fall National Meeting

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