Industry Provider Profiles
BioResearch Monitors, Inc.
Company Type Services
BioResearch Monitors, Inc. provides independent Quality
Assurance audit and consulting services to Organizations sponsoring
and/or conducting research within the purview of FDA's
Bioresearch Monitoring Program, ICH Good Practice Guidelines, and
related multinational quality standards. BioResearch Monitors, Inc.
is dedicated to ensuring data quality and regulatory acceptability
while fostering innovation in pharmaceutical research.
BioResearch Monitors, Inc was established in 1992. The Directors
of BioResearch Monitors Inc., have been managing compliance
operations and conducting Quality Assurance evaluations since the
inception of FDA's Bioresearch Monitoring Program during the
late 1970s. Our Quality Assurance and Clinical Research Associates
are all highly qualified professionals with advanced degrees and
significant industry and/or medical experience.
BioResearch Monitors, Inc. uses proprietary computer software,
customized for each study, to facilitate the collection, analysis
and reporting of quality assurance audit findings. Systems oriented
approaches to quality assurance are used to address and validate
the factors most important to each study's regulatory
acceptability, including adherence to its scientific rationale,
technical requirements, and applicable ethical and regulatory GCP
Specific services related to Good Clinical Practices include,
but are not limited to: Q.A. Audits of ongoing domestic and
international clinical trials; Pre and post-placement audits of
CROs, SMOs and Clinical Study Sites; Adjunct Clinical Trial
Coordination and Monitoring; Clinical Trial Data Validation Audits;
Computer Systems Validation Audits; Study file and regulatory
documentation reviews; Drug accountability and reconciliation
audits; Clinical & Biopharmaceutical Laboratory Inspections;
Preparation of Clinical Sites for regulatory inspection; Final
Report and Regulatory Submission Audits; Clinical trial "Audit
Certificates"; Prospective and retrospective clinical study
data collection and CRF completion; Training of Quality Assurance
and Clinical Research personnel; Development and review of Standard
BioResearch Monitors, Inc. also provides Quality Assurance Audit
and Evaluation Services for related Research and Development
activities, including GMP requirements for Clinical Supplies, GLP
requirements for Nonclinical Studies, and 21 CFR Part 11 rules for
computer systems used in support of these activities.
Good Manufacturing Practices Audit Services include: Sponsor and
Contract Clinical Supply facility evaluations: Drug Product
manufacturing; Drug Substance processing; Process & scale-up
validations; QA/QC systems evaluations; Product complaint
investigations; Labeling; Product Storage and distribution.
Good Laboratory Practices Services include: Sponsor and Contract
Laboratory Facilities Inspections; SOP development and review;
Final report and data audits.
Drawing on the broad range of experience obtained from over 20
years of working with a diverse spectrum of projects and clients,
we bring a unique level of expertise and understanding to each
quality assurance project we undertake. By using audit techniques
that are science-based and systems-oriented, we go beyond listing
deviations and violations, to provide our clients with descriptions
and analyses of critical underlying systems, together with sound
recommendations for process improvements. We understand and
appreciate the resources that research sites dedicate to hosting an
audit, and we work to ensure that those personnel whose work is
being audited are provided with a worthwhile, value-added
Paul L. Gittelson
BioResearch Monitors, Inc.
201 Markham Hollow Road
Tully, NY 13159
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