Facilitating Approvals for Clinical Studies
At DeSia, we recognize the importance of securing approvals from Ethics Committees (EC) and Competent Authorities (CA) as a fundamental phase in starting any clinical trial. Our team is dedicated to offering thorough assistance to guide you through this procedure, customized to meet the unique regulations of the country where your study takes place.
Customized Application Process
- Tailored Application Preparation: We prepare the necessary application files with great care, ensuring they meet the specific requirements based on the type of study (post-market or pre-market) and the regulatory demands of the target country.
- End-to-End Application Management: DeSia manages the entire application process on your behalf, from submission to follow-ups. Our goal is to streamline this process, making it as efficient and stress-free as possible for you.
- Liaison with Regulatory Bodies: We act as your representative in all interactions with Ethics Committees, the Ministry of Health (MoH), and Competent Authorities, guaranteeing that all communications are handled professionally and promptly.
- Proactive Issue Resolution: In the event of any deficiencies or queries from the regulatory bodies, our team acts swiftly to address and resolve these issues, ensuring that your application process continues towards approval.
By entrusting DeSia with the preparation and management of your application files for EC and CA, you gain a partner who is dedicated to your clinical study commences without delay, adhering to all regulatory standards.
