We offer a wide range of services to help you with getting your clinical trial off the ground in Europe. With our partners across Europe, we have extensive experience in navigating this complex landscape with its many country-specific and local requirements. Clinical trial application requirements vary widely across Europe with a poor level of harmonisation. At both a competent authority and ethics committee level, no two countries are the same. Our team of experts can help you every step of the way:
Preparation & Planning for your CTA
In some regions, successful initiation of your clinical trial will depend on good planning. In some countries, document procurement is easy as the requirements are in line with the European detailed guidance documents for clinical trials. In other regions, many add-ons are required, making the process more time consuming. In Poland for example, contract negotiation can take several months, and should be initiated well ahead of the proposed submission date.
Regulatory Review of Documents
It is imperative that the regulatory documents submitted are robust and will not lead to queries or formal deficiencies from competent authorities. Our team of experts can review your application and identify areas of weakness, leading to fewer clock stops and delays.
Submission of your CTA
Acorn Regulatory will submit your application to the relevant health authority and have a breadth of experience in navigating the various submission systems used by different countries.
Sponsors have a host of legal obligations post approval of the clinical trial, from SUSAR and annual safety reporting and notification of trial start and termination. Let the experts at Acorn guide you through these areas.
We are also closely following updates to the roll out of the incoming Regulation EU No 536/2014, and hope this new approach will lead to a truly harmonised approach in Europe that can compete with the US.
Talk to us today and find out how we can help you