Real Regulatory can provide the expert regulatory strategy to effectively manage your clinical trials across Europe and around the world in compliance with scientific and local regulatory requirements. These may be phase I, single site studies, or phase III global, multi-centred-trials.
Clinical Trial Consulting Services
- Advice on clinical trial authorisation (CTA) submission strategies
- Advice on using the Voluntary Harmonisation Procedure for CTA submission in multiple countries
- Advice on country-specific regulatory requirements
- Strategic advice and preparation of key submission documents
- Advice on Investigational Medicinal Product data
- Review of non-clinical and clinical data to support a CTA
- Review of sponsor-prepared documents
- Preparation and submission of your CTA submissions
- Advice on information to be made public for a clinical trial
- Management of large clinical trial management Clinical Research Organisations (CROs) including quality control of submissions
- Interaction with regulatory agencies to seek advice, agreement, and approval of your trial
- Management of communications with regulatory agencies
- Provision of issue-focused regulatory support throughout your trial
- Advice on and provision of trial maintenance.
Project: Clinical trial authorisation (CTA) submissions for an ophthalmic product Phase II trial across multiple European countries
Challenges: Clinical trial set-up had tight timelines and differing requirements across countries in Europe both within and outside the European Union (EU)
Our Solution: We have a close working relationship with local experts which allowed us to quickly and efficiently collect information on local requirements. Progress of core documentation was closely monitored through regular meetings with the client. Submissions to regulatory authorities were closely monitored through our quality control procedure for submissions. Submissions were made within timelines and timely approvals were received.
Project: Management of a cardiovascular product Phase III trial across Europe in conjunction with a large clinical trial CRO
Client: A mid-sized pharmaceutical company
Challenges: Clinical trial was run across a number of countries both within and outside Europe. There were multiple amendments submitted including an urgent safety measure.
Our Solution: Clearly defined responsibilities and procedures were set up at the start of the trial to ensure efficient management. This included regular meetings with the CRO and sponsor, procedures for amendment decisions and tracking and clear tracking and filing of submissions in all countries. All amendments submitted and end of trial is due in early 2013.
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