The European Union (EU) is listed as one of the most desirable regions to conduct a clinical trial and Innovaderm has positioned itself as a pacesetter in the industry for its operational capabilities and experience in conducting studies in this part of the world.
World’s largest growing market
Europe’s 27 countries and 447 million inhabitants is the world’s largest single market area and boasts optimal conditions for the management of phase 2 and 3 trials. Home to the European Medicines Agency (EMA), the organisation is responsible for the scientific evaluation of centralised Marketing Authorisation Applications (MAA). Once granted by the European Commission, the marketing authorization is valid in all EU member states, as well as Iceland, Norway and Liechtenstein.
High volume European clinical trials
Nearly 4,000 clinical trials are approved annually in the EU and the European Economic Area (EEA).
For the past 15 years, France, Germany, Spain, Italy and Belgium have consistently ranked in the top countries with the highest number of clinical trials.
Diverse geographical sites and patient populations
The ability to test new drugs among patients in varied geographical trial sites is paramount in determining the safety profile of medications, as well as their performance among individuals from various ethnic groups. Consequently, the EU offers the opportunity to investigate common and rare dermatologic diseases as well as aesthetic disorders with the support of experienced KOLs and PIs in reputable academic and private clinical research sites.
Comprehensive regulatory agency
The EMA is a review body that holds the capacity to concurrently manage the trial process in multiple countries. Assessments are conducted by the national agencies of the member states, bringing together the scientific resources of more than 40 public authorities within a network of over 4,500 experts in Europe.
Regulatory harmonisation of European clinical trials
The EU’s Clinical Trial Regulation (CTR) came into effect on January 31, 2022, to harmonise the submission, assessment and supervision processes for clinical trials in the EU. The Regulation enables sponsors to submit one application via a single online platform known as the Clinical Trials Information System (CTIS). On January 31, 2023, the use of CTIS became mandatory for all new clinical trial applications in the EU. A historical milestone in the research space, this new strategic approach now allows sponsors to submit an application to as many EU countries as required, with subsequent evaluations conducted simultaneously. Additionally, the CTR ensures improved information sharing and collective decision-making, increased data transparency, and enhanced safety standards for all clinical trial participants.
