Clinical Research Services
Our professionals from the Medical Writing Department have a wealth of experience, both clinical and in the preparation, translation and adaptation of trial documentation. Their expertise assures documents fully compliant with Good Clinical Practice (GCP) and all client and regulatory requirements.
Since 2010 Ramus Medical has successfully completed more than 32 BA/BE studies. Our Study Start-up Department collects documents and submits them to the competent authorities and Ethics Committees quickly and competently.
We are convinced that project management is the guarantee for a successful clinical trial. Each our project team involves highly qualified professionals.
Our biostatisticians play an essential role in the success of our clinical trial management. They are experts in planning, analysing and reporting of all Phases of drug development, in a wide range of therapeutic areas.
Our team is responsible for the following activities: Tracking and control of the incoming documentation; Preparation and maintenance of TMF, Preparation and delivery of Investigator’s Files to the study sites; Storage and management of other trial related documentation/material.
Regulatory Advising and Services
Regulatory strategy plan for drug products; Preparation and update of documentation for marketing authorization/renewal (CTD, NTA, NeeS) of drug products; Translation of PIL and SPC according to current QRD format; Submission to the Regulatory Authoritiesand follow up of the process of all types of regulatory procedures
Readability User Testing
Study design, protocol writing and questionnaire development; Database with potential test participants, Informed Consent Form; Face to face interviews etc.