Clinical Trials ConsultingClinical Trials Consulting, is a divsion of Nucleus Network and is a consultancy group which enables companies to go from pre-clinical studies into the clinic for the first time- it provides advice on all processes in getting a product to market.
Clinical Trials Consulting may start working with companies a year before they are ready to move to the clinic – eg providing preclinical gap analysis and assistance with writing drug brochures, generating clinical development plans, and assistance to seek out grant funding.
Specifically, the Regulatory Affairs and Quality Assurance department provides product development consultation services including regulatory strategy, pre-clinical gap analysis and preparation of clinical trial documentation. The department also provides regulatory submission services for clinical trials, marketing authorisation applications, GCP auditing capability and quality management system services with respect to clinical development and project management
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