We provide full-service solutions for Phase I-IV clinical research and for medical devices. We have clinical experts in over 20 countries and experience in the following therapeutic areas: oncology, CNS, cardiovascular, infectious disease, immunology, rheumatology, pulmonology, endocrinology, gynecology, gastroenterology, nephrology, ophthalmology, urology and dermatology.
Regulatory and Ethics Committee Submissions
Having solid experience in Clinical Trial Application (CTA) submissions and in-country personnel in over 20 countries across Europe and the CIS region, Biomapas provides a full-scope service in order to ensure the successful and timely start of a clinical study.
Our team is dedicated to delivering the highest quality support, providing the following services:
- Ethics Committee Initial Submissions;
- Ethics Committee Submissions for Amendments, Notifications and End of Trial Submissions;
- Regulatory Authority Initial Submissions;
- Regulatory Authority Submissions for Amendments, Notifications and End of Clinical Trial Submissions;
- Preparation and adaptation of Subject Information Sheet and Informed Consent Forms (SIS/ICFs) in line with local requirements;
- Translation of all study-related documents into local languages, including quality check.
For any inquiry regarding our services, please contact Biomapas Business Development team.