Dossier preparation, production, submission and maintenance

Friday 04 March 2011 Clinical Trial Application: preparation, submission and tracking


Support to the preparation, submission and tracking of the Clinical Trial Applications (CTAs) for a multinational company.

CLIENT


A world leader in Human Vaccines.


CONTEXT


In the scope of a multinational, multi-centric Phase III trial for a biological medicinal product in development, follow-up of the overall process of CTA preparation and submission to the Competent Authorities.


OBJECTIVES


Prepare, submit, track and follow up of CTAs for simultaneous submission to the Competent Authorities in various EU Member States (with tight timelines linked to vaccination seasons).


ORGANIZATION OF THE MISSION

Identification, collection and/or preparation and follow-up of CTA submission data as follows:

  • Identification of country-specific requirements.
  • Planning, writing/revising and coordination of the clinical documents required as part of the CTA package: clinical study protocol (including strategic advice on study design), IMPD, IB.
  • Setting up a tracking table for identification and preparation in order to obtain all documentation required for the CTA sections:

        1. General;

        2. Subject related;
        3. Protocol related;

        4. IMP related;

        5. Facilities and staff related;

        6. Staff related.

The tracking table highlights for each document: the title, where it is located in the internal document management system, the type of document, the owner or contributor and the timelines for finalization.

    

  • Coordination and preparation of documentation with specific actions on IMPD – preparation and/or completion of IMPD templates.
  • Publishing of CTA in electronic/paper format, including report production based on heterogeneous source documents.
  • Tracking and follow-up of submission dates, questions and answers and approval dates (including a tracking table with theoretical timelines/calendar).
  • Follow up submissions such as:
    1. Trial start date
    2. EC opinion submission to CA
    3. CTA substantial Amendment
    4. CTA end of trial
    5. CTA Annual Report
    6. CTA Study summary.

 

RESOURCES

1 FTE on an “in-sourcing” basis during 6 months with a Regulatory Affairs Assistant profile.

0,5 FTE on an “out-sourcing” basis during 6 months with a Senior Regulatory Affairs profile, including the role of medical writing;

.

RESULTS

Internal calendar and planning established. Clinical Trial Authorisation in all concerned member states with possible follow up activities ensured.

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