CRO* and SMO*
With medical progress, there comes the discovery of previously unknown diseases and new medicines are required to cure these diseases. BML established Allegro, Inc. in December 1998. Allegro arranges and coordinates clinical research at the request of pharmaceutical manufactures as a CRO and SMO, and offers consulting services so that applications for the approval of pharmaceuticals can proceed smoothly. Allegro also has a QAU* to assure the credibility of clinical research results.

*CRO : Contract Research Organization
*SMO: Site Management Organization
*QAU : Quality Assurance Unit

Investigative Research
The BML Pharmaceutical Clinical Trial Department provides pharmaceutical manufacturers with investigative analysis of new medicines in accordance with GLP and GCP.

“Omness,” BML’s Own Advanced Clinical Trial Support System
BML has developed an advanced clinical support system called “Omness,” which supports all clinical trial processes, from collecting specimen to reporting. This advanced system increases the speed of information gathering, rationalizes complicated trial procedures, shortens development time, and reduces pharamaceutical manufacturers’ development costs.

Services Provided by the Pharmaceutical Clinical Trial Department
• Preclinical Study *1 GLP requirements-compatible
Mutagenicity Tests	• Reversion test with bacteria • DNA repair assays using Bacillus Subtilis • Chromosomal aberration test with mammalian cells in culture
Toxicokinetics (a part of the toxicity study)	• Validation of measurements determined for a drug • Drug concentration measurement
• Clinical Trial *2 GCP requirements-compatible
Phase I	• Drug analysis
	• Validation and drug concentration measurement
	• General tests
	• Special tests
Phase IV	• Other tests
*1 BML received an A in all 25 Japanese GLP (Good Laboratory Practice) inspections. *2 BML complies with GCP (Good Clinical Practice).

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