Research Quality Assurance Strategy
We can help clients develop RQA strategies that are best suited to their business needs. An effective RQA function should deliver:
Evidence of compliance with Good Clinical Practices, Good Laboratory Practices, national regulations, other relevant guidelines, study protocols and internal standard operating procedures (SOPs)
Awareness of operational strengths and weaknesses with corrective actions to assure business integrity
A continuous and high level of inspection readiness
Customised QA strategies minimise regulatory and operational risk, improve quality and give the best value for money. South Barn Consulting Ltd has worked with a number of clients to construct quality, quality management, quality assurance and quality control strategies that fit their business and bring maximum benefit.
Research Quality Assurance Auditing
We conduct a wide range of independent GCP, GLP and GcLP research audits on behalf of clients anywhere in the world. These may be required to supplement existing audit programs, to manage workload peaks, or as part of inspection readiness. They can be stand alone or we can design and conduct a program of audits.
GCP audits form an essential component of oversight for clinical trials. We have abundant experience of all types of GCP audit.
GLP audits offer routine cover for pre-clinical research studies or for cause evaluations. We also carry out GLP service provider audits or system audits.
Good clinical Laboratory Practice (GcLP), now formally recognized by the Medicine and Healthcare products Regulatory Agency (MHRA), is a developing area and one in which we have first-hand audit experience.
Examples of specific audit types include:-
Research Sites, Study Databases, Study Reports, Research Facilities, Suppliers, Archive Facilities and process, Contract Organisations, Systems (Investigational Product Supply - Safety Reporting - Standard Operating Procedures - Informed Consent - Protocol Development - Data Management – Biometrics - Quality Control - Quality Assurance).
Regulatory Inspection and Inspection Readiness
Getting a good outcome from a regulatory inspection is very important for your business but is not always so straightforward. We advise clients on preparing for regulatory inspection, deliver mock inspections, provide support during an inspection, and assist in responding to regulatory inspection findings. South Barn Consulting Ltd has first-hand experience of regulatory inspection readiness and management in France and the UK.