Clinical Research Services

Medical Writing

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.

Study Start-up

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.

Study Management

We are convinced that project management is the guarantee for a successful clinical trial. Each our project team involves highly qualified professionals.

Monitoring

Ramus Medical provides study monitoring services for BA/BE and Phase I-IV trials.

Data Management

Our Data Management team works closely with other service departments.

Biostatistics

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.

Document Management

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.