HOW GCP Solutions CAN HELP
GCP Solutions limits itself to the GCP area. I don't attempt to provide consulting services in other areas such as GMP, QSR, GLP or Part 11. If you need those types of consulting audits, I can provide you with references. I offer a variety of comprehensive, independent, third party GCP services which can be structured to meet your needs. You can arrange to have these audits conducted under the attorney-client privilege, if confidentiality is required.
Comprehensive GCP Site Audits
Provides assurance that a study site is following the protocol and maintaining accurate and adequate case history records, IRB approvals are current and complete, subject consent forms comply with regulatory requirements, study material is properly accounted for and all adverse events are being reported in a timely manner. Do you know the difference between regulatory requirements and good GCP practices i.e. what you have to do vs what you should do?
Preparation for an FDA Inspection
I can offer a neutral, third-party assessment which can improve your chances of a successful inspection. I conducted FDA inspections and supervised FDA employees who conducted FDA inspections. My flexibility and commitment puts me there when you need it most. I can also be there during the FDA inspection and keep you informed of it's progress.
Do you know how to respond to Form FDA 483 citations?
Source Document Audits for Critical End-Point Data
Provides assurance that the data you submit to FDA as part of your PMA or NDA submssion was accurately transferred from subject treatment records to CRFs and into the study database.
Data Clarification Audits
Responses to data clarification requests [data queries] provide missing CRF information or clarify/correct previously submitted CRF information. DCF responses are not source documents. FDA will be looking to see if DCF responses are supported by subject treatment records.
Data Integrity Audits
These audits are custom developed to address specific issues and the need to develop acceptable source data records. Missing data can not be generated; however, if the data exists, the data can be copied to data location records.
Study Site Monitoring Audits and Monitor Training
Do you want to avoid an FDA Warning Letter which cites poor study monitoring practices? These audits can be accomplished using study monitoring reports; visits to some study sites may be necessary. Do you have an SOP for site monitoring that includes management of investigator non-compliance issues and/or poor study monitoring? Do you know that a written record of study monitor training is not required? Do you know that if you keep such records electronically, they may not need to be Part 11 compliant?
Quality System Assessment and SOP Development
Have you received an FDA Warning Letter and need assistance with the reponse? Is your system too complex and often not followed? I can evaluate your system and help develop new SOPs, where necessary. Do you have an SOP that addresses the IRB study approval process? What do you do when there is an IRB approval lapse?
Evaluation of Vendors and Service Providers:
Thinking of contracting with a monitoring or database development CRO?
Qualification audits can help assure that the tasks undertaken will be handled and documented in a way that meets regulatory requirements.Already working with a vendor or service provider?
A service audit can evaluate and verify work in-progress.Do you know that regulatory responsibilities can be transferred to a CRO for drug but not medical device studies? Contract CRO audits for medical device studies can help protect you from surprise letters from FDA based on CRO non-compliance.