Clinical trials are essential for developing pharmaceuticals. Successful clinical trials must begin and end with best-in-class sample management.
Study initiation, project planning, and collection management. Sample storage and bioprocessing. Cold-chain logistics and sample transportation.
We stand behind every stage of a clinical trial to support the safety, integrity, and regulatory compliance essential for FDA review.
No matter what phase of the clinical trial a drug is in, specific protocol is mandatory.
- 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 to maintain a secure temperature.
- Unique identifier labeling, preferably 2D-bar coded sample tubes, are required for proper identification.
- Samples must be kept in the correct labware.
Human pharmacology and first in-human trials with 10-100 participants.
Drug tested in 50-500 patients for therapeutic exploratory use.
Drug tested in multi-site trials with up to several thousand patients for therapeutic confirmatory use.
Post-marketing surveillance of therapeutic use conducted with thousands of participants.