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Biomedical research Clinical Trial protocol writing Clinical Trials CRO Site Selection Drug distribution in Clinical Trials Biotechonolgy LBBM Bioanalisis Auditing Consultancy Clinical Research Trials
 

AUDITING AND TRAINING

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  • Training
  • Co-monitoring
  • Auditing of procedures and results
  • Consultancy for set up of a trial
  • Regulatory consultancy

Training: We perform coaching on the staff at the sites to develop their own SOPs and facilities setup for a specific trial in compliance with ICH-GCP guidelines, meeting the standards for EMEA and FDA.

Co-monitoring: We organize co-monitoring visits on request, generating the corresponding reports and offering CRA training depending on the outcome of the report

Auditing of procedures and results: We audit systems, procedures and study results, involving our experienced staff of statisticians and health professionals. We also audit the execution of the different phases involved in the study (clinical, bioanalytical, central laboratory, data entry, etc)

Consultancy for set up of a trial: We offer consultancy on Sites selection for a study, given our large and close relationship with sites (private institutions, public hospitals, etc) and investigators of several specialties in health care. We also offer consultancy in Insurance policies according to national regulations.

Regulatory consultancy: We do regulatory assessment for a sponsor who has particular needs in knowing timelines of approval in Argentina, considering committees and ANMAT.
We estimate the probabilities of success of a study in Argentina, considering the patient population, special populations, involved investigators, study design and timelines, etc.

 

llbm At LBBM we offer training to investigators and site staff in GCP and SOP development, CRA coaching and co-monitoring, auditing of systems and results and consulting on specific local regulatory issues, approval timelines, insurance policies and customs regulations. llbm