We are actively providing hands-on support of Clinical Trial submissions throughout Europe for both Competent Authority and Ethics Committee approvals.
We provide regulatory operational oversight activities for CTs for trial phases I through III for a number of clients currently in global markets ex US and Canada, incorporating all European countries, and other diverse blocks including South America, Middle East, Asia, and South Africa.
For European countries, the new Clinical Trial Regulation will be applicable from the 31-Jan-2022. Our team has been preparing for this important change in the legislation and will be able to support submission as per the new requirements immediately it comes into force. Since the transition period to implement the new Regulation will transition over 3 years, support under previous the existing Clinical Trial Directive will continue to be possible, including help to transition the CT application from compliance with the Directive to the compliance with the new Regulation.
- Advice on clinical trial authorisation (CTA) submission strategies
- Support internal teams by clarifying and providing advice on current and planned regulatory legislation and guidance
- Provide detailed country requirements for CTA applications, under both Clinical Trial Directive and Clinical Trial Regulation.
- Act as regulatory affairs representative on project teams
- Review or author key submission documents like IMPD, IB, Protocol in compliance with European requirements
- Prepare core CTA submission packages including cover letter, clinical trial forms (such as EudraCT or CTIS data), and any required declarations
- Finalise and effect CTA submissions through the relevant associated systems to Competent Authority and Ethics Committee
- Support sponsor use of the Clinical Trial Information System (CTIS)
- Managing regulatory oversight of CRO activities including quality control of submissions
- Managing clinical trial lifecycle activities, including ensuring required timelines are adhered to such as for responses to Requests for Information (RFIs), relevant amendments, notifications and end of trial notifications
- Interaction with regulatory agencies to seek advice, agreement, and approval to run the trial
- Provision of issue-focused regulatory support throughout the entire lifecycle of the trial
- Escalation of any regulatory issues of key importance
- Regulatory sign off on-site release packages
- Support and participate in GxP agency audits
- Draft and input to RA Clinical Trial related SOPs
- Determining substantial/non-substantial amendments/modifications and compiling submission packs accordingly
- Advice on information to be made public for a clinical trial