LBBM CRO Contract Research Organization
LBBM Biomedical Research
History of LBBM Research Clinical Trials
Staff of LBBM Bioequivalence
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Clinical Trial Research in Argentina
Pharmacokinetic Studies
Biomedical research Clinical Trial protocol writing Clinical Trials CRO Site Selection Drug distribution in Clinical Trials Biotechonolgy LBBM Bioanalisis Auditing Consultancy Clinical Research Trials
 

QUALITY ASSURANCE

Our Quality Assurance Department controls the standard operating procedures (SOPs) and the working procedures and prepares the documentation and Quality Control Procedures that are necessary to guarantee that the studies are performed in compliance with Good Clinical Practices and that the laboratory data are generated in a context of Good Laboratory Practices. Our SOP´s govern all critical operations in trial management, data management, biostatistics, and clinical research report writing. These SOPs comply with all industry regulations set by our MoH, the FDA, EMEA and ICH. Project-specific SOPs are generated with delegation of responsibilities of our staff to the project, training and specific guidelines for the trial management.

Our staff is being continuously trained based on an annual training plan, ICH and GCP training and keeping updated is mandatory for all members of LBBM. All the training is documented on training records according to our own SOP´s.

We also offer the possibility to assist Investigator Sites in setting up their own Quality Assurance System, editing their clinical SOP´s, setting up a system for keeping all instruments involved in the evaluation of the patients calibrated and properly maintained and training the personnel in critical issues concerning sample handling, blood extractions and accurate timing, GLP procedures while processing the samples, etc.

 

llbm LBBM has been repeatedly audited by staff of the National Institute of Drugs (INAME), by the National Regulatory Agency of Drugs and Food Technology (ANMAT) and by sponsors, generating highly satisfactory audit reports. llbm