HOW QRCC CAN HELP YOU
QMS support ... for the SME moving into the clinic for the first time, it is mandatory according to Good Clinical Practice that you have a Quality Management System and SOPs to support your activities as the Sponsor of a clinical trial. QRCC can set up an appropriate and proportionate system to get you started and to ensure your compliance with GCP and national/international regulatory requirements. This service also includes ongoing oversight of your QMS, keeping it in line with the scope of your activities as your company develops. As your QA Consultant, QRCC will also ensure you are kept up to date with changes in the regulatory environment for clinical trial conduct that may impact on your specific development programme.
Regulatory Consultancy support ... as your Regulatory Consultant, an integral part of your Product Development Team, QRCC provides not only advice and guidance through the regulatory pathway for drug development, but also practical support in preparing and reviewing key documents to support a range of regulatory procedures. QRCC will also ensure you are kept up to date with changes in the regulatory environment for clinical trial conduct that may impact on your specific development programme.
Early phase clinical trial monitoring ... where you are in need of an experienced CRA to monitor your early phase clinical trial, be it with a Phase I unit or within a hospital setting, QRCC can provide a competent pair of hands, able to handle some of those unexpected situations arising with early phase trials. QRCC can also hold and maintain your Trial Master File for the duration of the study if needed.
Clinical trial QA audits ... QRCC provides a comprehensive range of audit services, including audits of clinical trials with Advanced Therapy Investigational Medicinal Products (gene therapies and stem cells). QRCC has a robust understanding of the additional regulatory requirements to be considered when conducting clinical trials with ATIMPs.
EU Legal Representative ... for any non-EU company planning to conduct a clinical trial in any of the EU Member States. QRCC can facilitate this through QRC Ireland ("QRCI", our recommended partner) who can act as your Legal Representative in the EU, a statutory requirement where you, the Sponsor, is not established in the EU. As part of this service, QRCI will also ensure that you are kept up to date with changes in the regulatory environment for clinical trial conduct that may impact on your specific development programme, and will be available to provide you with ad hoc regulatory advice on European procedures as needed.
These are just a few examples of how QRCC can support the small/medium biotechnology or pharmaceutical company. For more information about our complete range of services, please get in touch: email@example.com