Regulatory Affairs
Ethics Submissions
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A smooth and effective comprehensive process - with you every step of the way
At MAC, behaving ethically is part of everything we do and we take pride in our commitment to industry regulations. However, as a leading provider of clinical trials we extend this commitment further, and openly disclose more than the compulsory information currently required. Our open approach is a driving factor that enables us to build strong relationships with sponsors, patients, employees, partners and the public. We aim to engage with these stakeholders at all times and realise their individual requirements to generate the trust needed to sustain our continued development.
Ethics and Regulatory Submissions
The clinical trial ethics and regulatory process at MAC is very efficient, with effective time management applied to ensure deadlines are adhered to, for Central and Local submissions respectively. MAC has experience of working with ethics and regulatory frameworks on clinical trials globally. Having a depth of knowledge and understanding gained from an extensive background in conducting global clinical trials, the teams quickly and efficiently produce comprehensive study-specific documents generated and completed for ethics submission within required timelines.
Features of the process:
- Centralised ethics mailing address
- MAC has excellent working relationships with regional ethics committees
- NHS R & D not required for all MAC Clinical Research sites
- Focused operational team responsible for review of submission documents to ensure rapid turnaround
- Established connections with Comprehensive Local Research Networks
- Completion and submission of Intergrated Research Application System (IRAS) – Multi-Centre Research Ethics Committees (MREC) forms with average approval time of 30 days following MREC meeting
- Completion and submission of Site Specific Assessments with average approval time of 6 days following confirmation of valid application