Introduction and Areas of Services
In the current COVID-19 situation, the EMA has provided guidance that on-site audits should, in general, be avoided or postponed. However, the ICH Guideline on Good Clinical Practice E6(R2) still holds, and trial sponsors are still obliged to provide assurance during the pandemic of the quality of their trials. Also, the regulatory agencies are adapting and intend to conduct remote inspections to check how the new guidelines to manage trials during COVID-19 are being implemented by companies.
To that end, Tower Mains Ltd.’s Quality Assurance Group (TMQA) has a comprehensive selection of remote services to assist their clients during this unprecedented time. TMQA has a broad offering of services across GLP, GCP, GMP and quality systems conducted by their team of experienced QA professionals.
We use Microsoft Teams as our primary communication and collaboration platform but would be happy to use clients’ systems if preferable and that are adequately compatible and secure.
Risk Mitigation Plan Development and Support
Based on the FDA and EMA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, there is a critical need for risk assessments to be made by trial sponsors, CROs and potentially the sites. We recognise that developing risk management plans can be very time consuming and we offer our experience and support in this area. Based on the FDA and EMA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic, TMQA can assist clients in the development of comprehensive risk assessment documents to enable effective planning, during and moving on from the pandemic, enabling provision of objective evidence of effective oversight to regulatory authorities .
Tower Mains has a range of training courses run by professionals who are actively involved in the field; hence they can share real-life experiences. The global guidance on managing trials under COVID-19 is being updated every month and keeping up to date with this whilst mitigating existing risks to ongoing trials can be challenging. Therefore, Tower Mains offers ongoing training courses to provide the regulatory updates.
In addition, bespoke training courses can be prepared to specification on a case by case basis.
For course bookings and enquiries please email firstname.lastname@example.org
Site Support and Advice
We can provide training and support to site staff, especially investigator site personnel, including advice on quality and regulatory authority expectations during COVID-19. Consultation can be focused on a specific study. For further information, contact us at email@example.com.