Development Support

Clinical Trial Applications

A Clinical Trial Applications is a legal requirement before starting a clinical trial on any medicinal product within an EU country. Approval must be received from the appropriate national regulatory agency, prior to study start. RApport has hands-on experience with CTAs across Europe and Phases of development in a wide range of products and therapeutic areas. RApport can assist with all aspects of the CTA process including:
  • Guidance and assistance with the preparation of CTA documentation including the review and authoring of core documents e.g. protocol, IMPD and IB;
  • Identification and preparation of the required country specific documentation for the CTA submission;
  • Managing the submission process nationally or through the VHP, liaising with the regulatory agency to gain approval;
  • Management of the CTA after approval, from substantial amendments through to the end of trials and submission of the Clinical Study Report

Medical Writing

Your development plan is likely to have been long and complex. Our Medical Writing team is experienced in presenting your data in a clear and logical manner, to ensure your Key Messages are delivered consistently and coherently. RApport can assist you with all aspects of medical writing including:
  • Full authoring to submission ready status, strategic outlines, or expert review with or without QC;
  • Development of documents for Module 2.5, 2.7 and 5 within the CTD, which can be optimised for EU, US or global submissions;
  • Clinical development documents (e.g. Investigator Brochures, protocols, interim and final study reports);
  • Clinical regulatory documents (e.g. responses to questions, white papers)

Orphan Drugs

"Orphan drugs" are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders that are rare. The development path for orphan drugs is not always straightforward. RApport has experience with numerous orphan drug development programmes and can help advise you with the:
  • Establishment of the orphan drug status of your product;
  • Preparation and submission of orphan drug designations;
  • Regulatory strategic support including maintenance of orphan status

Project Managment

At RApport we believe that project management is all about people not tools. Yes, we use tools to monitor projects but project management is so much more. You may not have enough resource to monitor your project and keep it on track. As regulatory is involved in all aspects of development we are uniquely positioned to provide project management support alongside our regulatory expertise. We have managed projects for numerous companies, using regular meetings, status reports and our experience to keep the project on track and all the balls in the air. We can become part of your team and offer as little or as much support as you need.