Phase I |
Phase II |
Phase III |
Phase IV |
Conduct human pharmacology and first in human trials with 10 to 100 participants. Determining safety and tolerability are the primary objectives. Clearly defined study objectives among the intended target population demographics are essential. The correct testing must be conducted to achieve the desired result. Ethically consented samples with correct annotation must be collected and stored in a controlled environment for secure, temperature-safe shipment. Unique identifier labeling, preferably 2D-bar coded sample tubes, are required to ensure proper identification. Samples must be kept in the correct labware and stored in a controlled environment for the appropriate time. |
Drug is tested in 50 to 500 patients for therapeutic exploratory use. Primary objectives are efficacy and dose ranging. Clearly defined study objectives among the intended target population demographics are essential. The correct testing must be conducted to achieve the desired result. Ethically consented samples with correct annotation must be collected and stored in a controlled environment for secure, temperature-safe shipment. Unique identifier labeling, preferably 2D-bar coded sample tubes, are required to ensure proper identification. Samples must be kept in the correct labware and stored in a controlled environment for the appropriate time. |
Drug is tested in multi-site trials with several hundred to several thousand patients for therapeutic confirmatory use. Primary objectives are confirming efficacy and monitoring side effects in a larger population. Clearly defined study objectives among the intended target population demographics are essential. The correct testing must be conducted to achieve the desired result. Ethically consented samples with correct annotation must be collected and stored in a controlled environment for secure, temperature-safe shipment. Unique identifier labeling, preferably 2D-bar coded sample tubes, are required to ensure proper identification. Samples must be kept in the correct labware and stored in a controlled environment for the appropriate time. |
For drug and cell therapy/regenerative medicine products, post-marketing surveillance of therapeutic use is conducted with thousands of participants. Primary objectives are determining adverse events compliance and drug-drug interactions. Clearly defined study objectives among the intended target population demographics are essential. The correct testing must be conducted to achieve the desired result. Ethically consented samples with correct annotation must be collected and stored in a controlled environment for secure, temperature-safe shipment. Unique identifier labeling, preferably 2D-bar coded sample tubes, are required to ensure proper identification. Samples must be kept in the correct labware and stored in a controlled environment for the appropriate time. |
Azenta Life Sciences Solutions |
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• Pre-labeled BSA Lab Services collection kits, including storage tubes, assure standardized, trackable sample fulfillment |
• Pre-labeled BSA Lab Services collection kits, including storage tubes, assure standardized, trackable sample fulfillment |
• BSA Lab Services collection kits, including storage tubes, assure standardized, trackable sample fulfillment |
• BSA Lab Services collection kits, including storage tubes, assure standardized, trackable sample fulfillment |
• FluidX 2D barcoded sample storage tubes enable easy processing and tracking |
• Pre-labeled FluidX 2D barcoded sample storage tubes enable easy processing and tracking |
• Pre-labeled FluidX 2D barcoded sample storage tubes enable easy processing and tracking |
• Pre-labeled FluidX 2D barcoded sample storage tubes enable easy processing and tracking |
• Azenta automated sample scanning/ capping/sealing instruments provide precise, high-throughput processing |
• Azenta automated sample scanning/ capping/sealing instruments provide precise, high-throughput processing |
• Azenta automated sample scanning/ capping/sealing instruments provide precise, high-throughput processing |
• Azenta automated sample scanning/ capping/sealing instruments provide precise, high-throughput processing |
• FluidX sample cooling systems ensure standardized/controlled cooling and freezing |
• FluidX sample cooling systems ensure standardized/controlled cooling and freezing |
• FluidX sample cooling systems ensure standardized/controlled cooling and freezing |
• Biostorage Technologies’ cold-chain solutions provide controlled condition short-term storage and sample transport |
• Biostorage Technologies offers onsite or offsite sample biorepository storage at -20° C to -190° C |
• Biostorage Technologies offers onsite or offsite sample biorepository storage at -20° C to -190° C |
• Biostorage Technologies offers onsite or offsite sample biorepository storage at -20° C to -190° C |
• Biostorage Technologies offers onsite or offsite sample biorepository storage at -20° C to -190° C for API and drug products and cell therapy products |
• BSA Lab Services sample preparation and bioprocessing provide integrated, state-of-the-art scientific approach and technology infrastructure |
• BSA Lab Services sample preparation and bioprocessing provide integrated, state-of-the-art scientific approach and technology infrastructure |
• BSA Lab Services sample preparation and bioprocessing provide integrated, state-of-the-art scientific approach and technology infrastructure |
• BioStudies analytical tools integrate sample inventory data with laboratory, donor consent, and clinical data |
• Biostorage Technologies’ cold-chain solutions provide controlled condition short-term storage and sample transport |
• Biostorage Technologies’ cold-chain solutions provide controlled condition short-term storage and sample transport |
• Biostorage Technologies’ cold-chain solutions provide controlled condition short-term storage and sample transport |
• Biostorage Technologies’ BioInventory solution offers fast, flexible, and secure sample data viewing from a single, global database |
• BioStudies analytical tools integrate sample inventory data with laboratory, donor consent, and clinical data |
• BioStudies analytical tools integrate sample inventory data with laboratory, donor consent, and clinical data |
• BioStudies analytical tools integrate sample inventory data with laboratory, donor consent, and clinical data |
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• Biostorage Technologies’ BioInventory solution offers fast, flexible, and secure sample data viewing from a single, global database |
• Biostorage Technologies’ BioInventory solution offers fast, flexible, and secure sample data viewing from a single, global database |
• Biostorage Technologies’ BioInventory solution offers fast, flexible, and secure sample data viewing from a single, global database |
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