Case Studies
TMQA save a US client time and money conducting their European audits
A US client conducting clinical trials intended for submission to the US and European receiving authorities was having difficulty with the travel associated with several European locations due to the time and costs involved. The European audits were conducted by TMQA on behalf of the client, using the templates and formats of TMQA after the client approved these as compatible with their own systems and formats.
TMQA carry out 11 site audits for a client conducting clinical trials
A client conducting clinical trials intended for regulatory submission identified a gap in their auditing resource and contacted TMQA to request support. TMQA is conducting up to 11 site audits in various locations, including Eastern European countries. The client selects the site to be audited, and via a secure web portal, documents are shared. TMQA uses the templates and formats required by the client to ensure the reports from the audits fit seamlessly within the quality system of the client.
Successful Clinical CRO Continues Partnership with TMQA
TMQA began providing a Quality Assurance service for a growing Clinical CRO in 2005 and the relationship has gone from strength to strength. TMQA provided the CRO with QA SOPs which were incorporated into the Quality System and have been operating the Audit Programme for the CRO, performing audits when required, attending client audits and providing training."We have been collaborating with TMQA for the past five years and during this time they have fully supported our audit programme. Conducting both internal audits and our due diligence vendor audits, they have been very flexible in their approach, responding to requests for assistance and attendance at audits often at very short notice. TMQA have taken time to get to know us and understand our needs and are very much part of our team. I would have no hesitation in recommending their services." VP (Europe) – Major Clinical CRO
TMQA Credited with Successful Entry into the UK GLP Compliance Programme
TMQA were asked by a client to assess their systems for compliance with the requirements of Good Laboratory Practice (GLP), prior to their application for entry into the United Kingdom GLP Compliance programme. An inspection of the systems and procedures in place was conducted by two of the TMQA auditors, and a number of action points were brought to the attention of Management. A corrective action plan was implemented, and some weeks later the organisation was granted entry into the UK GLP Compliance programme following a successful inspection by the Medicines and Healthcare products Regulatory Agency (MHRA)."TMQA provided wonderful assistance during the initiation of the company; setting up and monitoring the Quality Management System and thereafter actively supporting my membership of the MHRA GLP Compliance Programme. TMQA have worked seamlessly with us since our inception in 2006, providing excellent communication, and responding rapidly and efficiently to any requests. TMQA are very knowledgeable in pharmacokinetic analysis and especially toxicokinetics, thereby providing very efficient Quality Assurance Audits of pharmacokinetic reports, compliant with OECD GLP and compatible with ICH GCP. TMQA also provide stress-free facility audits leaving no stone unturned. TMQA’s expertise in GLP and GCP regulatory requirements is second to none; I have had no need to look elsewhere for QA support and would not hesitate to recommend their services." Managing Director, UK GLP Compliance Programme Member