SERVICES

Clinical Research Management and Consulting

•    Overall study management, including planning and design
•    Preparation of Study Protocols, Informed Consent Forms (ICF), Investigator Brochures (IB), Case Report Forms (CRF)
•    Handling of Study Agreement
•    Preparation of Final Clinical Study Reports
•    Preparation of Clinical Evaluation Reports (CER)
•    Monitoring (CRA) visits
•    Medical Monitoring (MD)
•    Set-up of clinical departments
•    Development of clinical SOPs (Standard Operating Procedures)
•    Preparation and management of essential study documents

Scientific Medical Writing

•    Manuscripts for peer-reviewed journals
•    Clinical study reports
•    Clinical summaries and overviews
•    Presentation of scientific data
•    Literature review and analysis
•    Academic works, including M.Sc. / Ph.D. thesis

Clinical Quality Assurance (CQA) / Good Clinical Practice (GCP) Audit of Clinical Trials

•    In-house audits
•    Sponsor/Monitor audits
•    Investigator file audits
•    Informed consent audits
•    Site Audits
•    Audits of study reports

Training Courses and Workshops 

•    ICH-GCP Guidelines
•    Medical Writing
•    Clinical Development Strategy
•    Post Marketing Clinical Activities
•    CER preparation