Clinical Trials

Service overview

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 clinical trial application submission in multiple countries
  • Advice on country-specific regulatory requirements
  • Strategic advice and preparation of key submission documents including Study Protocol and IMPD
  • Review of non-clinical and clinical data to support a CTA
  • Review of sponsor-prepared documents
  • Preparation and submission of your CTA
  • Advice on information to be made public for a clinical trial
  • Management of large clinical trial, management of 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
  • Preparation and submission of substantial amendments, end of trial notifications, any country specific requirement and study maintenance activities
  • Post approval obligations
  • Submission of CSR and preparation of CSR synopsis for EudraCA result posting.

Typical projects

Project: Clinical trial authorisation (CTA) submissions for an ophthalmic product Phase II trial across multiple European countries
Client: CRO
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. Meetings with the CRO and sponsor were held on a regular basis. There was clear tracking and filing of submissions, amendments and approvals in all countries.

We are following progress of the new Clinical Trials Regulation (EU) No536/2014 and applying the necessary changes in preparation for its implementation in 2019.

Key features if the new regulation include:

  • Identical rules for conducting clinical trials throughout the EU
  • Increase in the efficiency in approval process for clinical trials
  • Single submission and approval of multinational clinical trial applications through an EU Clinical Trial portal and database
  • A harmonised procedure for assessment by member states
  • Strictly defined deadlines for assessment
  • Involvement of the ethics committees in the assessment procedure.

 

See our Frequently Asked Questions (FAQs)

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