SubscribeMany pharmaceutical development companies with projects entering Phase I and II clinical trials are “virtual” companies, and management of the trials and the manufacture of the Investigational Medicinal Product is outsourced to contractors.
Recent legislation has confirmed that clinical trial sponsors are responsible for the conduct of their trials, even if the work is sub-contracted. Regulatory authorities expect to see evidence that sub-contractors have been audited, and appropriate Technical Agreements in place, before work begins, and that the sponsor regularly monitors their work to ensure that project and regulatory objectives are being met.
This can be a difficulty for small companies that do not have sufficient quality assurance expertise to carry out this oversight themselves, and who cannot afford the expense of employing a full-time member of staff, or for this staff member to be travelling to audits and project meetings at contractor sites.
Somerset House Consultants is able to resolve this by offering a "virtual" Quality Assurance service. An experienced quality assurance specialist works for the clinical trial sponsor and reports directly to them. However, the client only pays for the resource they use - typically one to three days per month - much more cost-effective than a full-time employee. Amongst the tasks carried out by this quality assurance specialist are:
- Setting up quality systems and Standard Operating Procedures to meet legislative requirements
- Auditing CRO's and Investigational Medicinal Product manufacturers for compliance with GCP and GMP
- Confirming that contractors had appropriate staff, facilities and experience for the particular project
- Drawing up Technical Agreements with each contractor
- Ensuring that documentation generated by contractors, for instance labels, patient information leaflets or product specifications, complied with the regulatory submissions, GCP and GMP
- Ensuring that the CRO's and contract manufacturers continued to meet the sponsor's and regulatory requirements, including attendance at project meetings
- Problem-solving and troubleshooting
This quality assurance service allows the trials to be carried out on-time, within budget and in full compliance with GCP and GMP.