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GCP Compliance Consulting

GCP????

GCP audits are becoming increasingly important to all parties involved in clinical research and are an essential part of ICH GCP. They help evaluate the effectiveness of all monitoring activities, assess the quality of clinical data and help prepare for regulatory inspections. At Blue Bell Consulting (BBC), we offer GCP auditing services covering one or more of the following aspects of clinical studies:

  • Investigator Audits/ Facility Audit

We verify and assess through audit procedures compliance with FDA regulations to assure that data submitted to the FDA in specific studies is substantiated by records. These audits are conducted to standard operating procedures to assure compliance with ICH GCP and/or FDA regulations. This audit includes clinical and laboratory facilities, procedures and practices.

  • Pre-Regulatory Inspection Audits

We conduct Pre-Regulatory Inspection Audits, working with quality and regulatory specialists in your organization to analyze current policies, practices, SOPs and to observe daily work behaviors. We will produce observations and suggestions which, when correctly implemented, can better prepare your organization for an FDA audit.

  • Contract Suppliers Audits (Clinical Laboratories/ Contract Research Organization/ Off-site archiving facilities)

We independently audit contract suppliers to assure that they can offer you the quality service you expect. This audit involves those organizations or corporations which have entered into contractual agreement with a sponsor to perform one or more obligations for the sponsor.

  • Clinical Study Report Audits

We audit clinical study records at the site, including comparing case report forms with the source documents and reviewing clinical supply accountability records, biological sample shipment records, and other study files. We offer you highly independent audit services to assure you the report has been written in compliance with ICH GCP and correctly reports and summarizes the data.

  • Database Audits

We conduct database audits to ensure that data is handled in a secure manner, accurately transferred to databases, maintained with appropriate documentation and to assure that your database truly reflects the data captured on the Case Report Forms.

  • Computer System Audits

We provide guidance on how computer systems should be validated to meet cGCP requirements and/or provide highly independent audits to assure that your computer systems are in compliance with the FDA requirements.

  • Standard Operating Procedure Writing

We offer an SOP writing/review service to assure compliance with current GCP requirements. We evaluate the efficiency and feasibility of your procedures.

  • GCP and Audit Training

We train your monitors so that they reach high quality monitoring standards and work in full compliance with the applicable SOPs and national regulations as well as ICH-GCP guidelines.