BioResearch Monitors, Inc., Practices

To ensure that scientific and ethical standards are met in the conduct of clinical trials, the experienced clinical scientists of BioResearch Monitors, Inc. use proprietary computer based audit tools customized to each protocol, to collect, analyze and report quality assurance audit findings. This is a systems oriented approach to data quality assurance, driven by the study protocol, that addresses and seeks to validate the assumptions, technical requirements and documentation inherent to the study's scientific rationale and regulatory acceptability. Integral with this approach is an evaluation of the activities undertaken, and documentation generated, in support of general ethical and regulatory GCP requirements.

To maintain independence and objectivity in the conduct of Quality Assurance evaluations, BioResearch Monitors, Inc. does not undertake the conduct or management of clinical trials.

	Pre-placement audits of Contract Research Organizations (CRO), Site Manegement Organization (SMO) and Clinical Study Sites;
	Independent QA assessments of CRO study management and CRO managed studies;
	Interim quality assessments of ongoing domestic and international clinical trials;
	Validation audits of completed clinical trials;
	Study file and regulatory documentation reviews;
	Drug accountability and reconciliation audits;
	Clinical Laboratory, Bioanalytic Laboratory and other Clinical Facilities inspections;
	Institutional Review Board (I.R.B.) evaluations;
	Preparation of Clinical Sites for Regulatory Inspections;
	Clinical trial "Audit Certificates";
	Final Report and Regulatory Submission Audits;

Adjunct Clinical Trial Coordination and Monitoring services include:
	Pre-study site evaluation and setup;
	Ongoing data verification, test article accountability, and study file monitoring;
	Study-site closeout visits;
	Prospective and retrospective clinical study data collection and CRF completion.

Good Manufacturing Practices
BioResearch Monitors, Inc. performs GMP evaluations of Sponsor and Contract Clinical Supply operations including:
	Drug Product manufacturing;
	Drug Substance processing;
	Process & scale-up validations;
	QA/QC systems evaluations;
	Product complaint investigations;
	Labeling;
	Storage and distribution;
	GMP required records & reports.

Good Laboratory Practices
	Sponsor and Contract Laboratory Facilities Inspections;
	SOP development and review;
	Final report data audits;
	Other required QAU functions.

Other Related Q.A. Services
	"Due Diligence" assessments of Research and Development operations and research projects;
	Computer validation audits;
	Training of Clinical Research and Quality Assurance personnel;
	Standard Operating Procedures (S.O.P.'s) evaluation and development.