Overview

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.

Typical Pathway

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.
Clin

Phase I
Human pharmacology and first in-human trials with 10-100 participants.

Phase II
Drug tested in 50-500 patients for therapeutic exploratory use.

Phase III
Drug tested in multi-site trials with up to several thousand patients for therapeutic confirmatory use.

Phase IV
Post-marketing surveillance of therapeutic use conducted with thousands of participants.

Brooks Solutions

Our solutions support every phase of the clinical trial.