Supporting pharmaceutical development with precise testing
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 |
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Mutagenicity Tests |
Reversion test with bacteria
DNA repair assays using Bacillus Subtilis
Chromosomal aberration test with mammalian cells in culture |
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Toxicokinetics
(a part of the toxicity study) |
Validation of measurements determined for a drug
Drug concentration measurement |
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Clinical Trial *2 GCP requirements-compatible |
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Phase I |
Drug analysis |
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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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