BioResearch Monitors, Inc.
201 Markham Hollow Road
Tully, NY 13159, USA
Contact Person: Paul Gittelson
Bioanalytical Data Audits/Laboratory & Validation Evaluation, Clinical Trial Monitoring, Computer System Validation, Consulting, Contract Auditing, Data Validation, GCP Compliance, GLP Compliance, GMP Compliance, Quality Assurance/Control
Quality Assurance Audits for Good Clinical Practice and
Regulatory Compliance Services for Pharmaceutical
Research & Development
(GCP, GMP, GLP)
BioResearch Monitors is a leading independent provider of research-related quality assurance audit and compliance consulting services. Since 1992, BioResearch Monitors has been providing worldwide QA services to major and emerging pharmaceutical and biotechnology companies, CROs and related 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 is dedicated to ensuring data quality and regulatory compliance in all phases of pharmaceutical research. The directors of BioResearch Monitors have been managing and conducting quality assurance operations since the inception of FDA's Bioresearch Monitoring program. Our Quality Assurance Associates are all highly qualified, with advanced degrees and significant, relevant industry and/or medical experience.
Good Clinical Practice: To ensure that scientific and ethical standards are met in the conduct of clinical trials, BioResearch Monitors uses proprietary computerized audit tools, customized for each project, to efficiently and consistently collect, analyze and report quality assurance audit findings. This focused systems oriented approach to quality assurance is designed to assess and validate study conduct and documentation to assure regulatory compliance and conformance to protocol, SOP and contractual requirements. Our methodology fully evaluates the activities and documentation underlying study data integrity and GCP ethical and regulatory requirements. To maintain independence and objectivity in performing Quality Assurance evaluations, BioResearch Monitors does not conduct or manage clinical trials.
GCP services for domestic and worldwide clinical trials include, but are not limited to:
- Pre- and post project placement audits of Investigator Sites, IRBs, CROs and SMOs;
- Central and local clinical, biopharmaceutical, electrophysiology and imaging laboratory audits;
- EDC, Data management and data validation audits;
- Study file and regulatory documentation reviews;
- Drug accountability and reconciliation audits;
- Database, final report and regulatory submission audits;
- Computer systems validation audits;
- Preparation of Sponsor/Monitor and Clinical Investigator sites for regulatory inspection;
- Training of quality assurance and clinical research personnel;
- Development and review of Standard Operating Procedures;
- Adjunct clinical trial coordination and monitoring;
- Prospective and retrospective clinical study data collection and CRF completion.
Good Laboratory Practice: GLP services include sponsor and contract laboratory facilities inspections; Critical phase inspections; SOP development and review; Data and final report audits; Adjunct QAU functions.
Good Manufacturing Practice: GMP services are principally related to Clinical and Nonclinical investigational products and include inspections of in-house and contracted drug product and drug substance manufacturing, packaging and labeling; Process and scale-up validations; QA/QC systems evaluations; Product complaint investigations; Logistics, storage and distribution audits.
Please call BioResearch Monitors, Inc. to discuss how our Quality Assurance programs and services can add value and confidence to your research projects.