Overview

Clinical trials are conducted to develop pharmaceuticals for human pharmacology, therapeutic, exploratory, confirmatory, and therapeutic use.

In the four phases of a clinical trial, best-in-class sample management practices involve study initiation, project planning, collection kit management, sample storage and bioprocessing, cold-chain logistics and sample transportation – along with data connectivity solutions.

Brooks has developed solutions for every stage of a clinical trial that 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 to ensure proper identification.
  • Samples must be kept in the correct labware and stored in a controlled environment for the appropriate time or when shipment is required.
Clin

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

Phase II
Drug is 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 – and help push much-needed drugs to market.