Specialized service requirement Non-standard data capture Communication problems Study mismanagement Non-compliant operations Inadequate resourcing

Identify suitable vendor Develop study protocol and methods Contract development Establish compliance (GLP/GCP/GMP) Identify and set-up documentation needs Supplement resources where required Staff training

Non-standardized assays Non-transferable methodology Difficult product characterization Problems with outsourcing Manufacture/release problems

Assay development and validation Technology transfer Analytical troubleshooting Establish validation plan Set realizable product specifications

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