Regulatory service and strategy for your trials
August 01, 2018
Regulatory services are essential to ensure clinical trials are conducted safely, responsibly, and to the best standard. Ground-breaking therapies are often associated with complex clinical and regulatory routes. At the same time, the clinical environment is moving away from standard clinical trials, as market changes and advances in science make it more difficult to direct applications to a “one size fits all” track. As these trends evolve within agencies across the world, regulatory support needs to hold expert knowledge while being adaptable to changing laws.
The decision to conduct a clinical trial in the US or in Europe is often driven by the clinical strategy and market expectations of the therapy. Some consistency between the Food and Drug Administration (FDA) and regulatory bodies within the European Union has been implemented1–3, demonstrating the initiative to provide therapies to more and more patients while simplifying the application process. Navigating the regulatory space in Europe requires a knowledgeable team, as procedural routes may vary from country to country. For example, regulations can differ on ethics legislation, informed consent procedures and representation, liability, investor requirements and site qualification, and requirements for country-specific documents. Regulatory teams should also provide support if novel therapies and new clinical trial designs require acceptance due to cultural or social norms.
Neox’s regulatory team are local experts with deep knowledge of national guidelines and procedures. We manage our submissions centrally, seamlessly coordinating key aspects of the local regulatory processes and document management practices. We constantly have our ears to the ground, interacting directly with the local authorities and ethics committees to obtain feedback and approval as fast as possible. Our regulatory submission services include coordination of all global activities, ensuring the trials are conducted cohesively, accurately, and follow the strict regulatory guidelines that vary country to country.
We provide our clients with a realistic timeline to the first site initiation visit. Immediately, we prepare translations, local documentation and preparation, submissions, validation and a full review period, with time allocated for at least one round of questions from the regulatory agencies and ethics committees. We are committed to putting in 110% to shorten the trial timelines. We thrive on local expertise and have experienced much shorted timelines than those officially establsihed by regulatory agencies.
Our regulatory services include:
- registering the trial in the EudraCT system,
- preparing and submitting the clinical trial dossier to the local ethic committees and regulatory authorities
- providing notification of the trial to the local government
- tracking submissions and correspondence through initial approval
- obtaining import/export licenses for drug and non-drug supplies
- tracking correspondence, timelines, and reporting obligations
- translating study documents into the local language
We also offer expert consulting strategies for IND to IMPD transfer, request for scientific expert advice meetings, and submission procedures related to pediatric investigational studies.
Neox provides tailorable solutions for our clients. As a full service CRO, we hold over 15 years of experience working with clients ranging from biotech startups and big pharma. Clinical trials continue to move towards globalization, and our resources allow us to work both in the US and the EU. Please reach out if you are interested in learning more.
Mary Nguyen, Ph.D.
Business Developer & Project Manager for Business Expansion
NEOX USA LLC
8910 University Center Lane
Suite 400, San Diego, CA 92122
- Van Norman, G. A. Drugs and Devices: Comparison of European and U.S. Approval Processes. JACC Basic to Transl. Sci. 1, 399–412 (2016).
- Gaffney, A. Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients. Regulatory Professional Affairs Society (2015). Available at: https://www.raps.org/regulatory-focusTM/news-articles/2015/3/bill-wants-drugs-approved-in-europe-to-be-available-more-quickly-to-us-patients.
- Parvizi, N. & Woods, K. Regulation of medicines and medical devices: Contrasts and similarities. Clinical Medicine, Journal of the Royal College of Physicians of London 14, 6–12 (2014).