With its presence in more than 40 countries and an in-depth understanding of the regional requirements of regulatory authorities, ClinTec can provide expert Medical Monitoring and Safety management of your international clinical trials.  Our medical monitors each have more than 5 years of experience within cardiology, ophthalmology, respiratory, oncology and neurology.

Medical Monitoring and Pharmacovigilance Services include:

• Study document review (IB, protocol, CRF, ICF, study manual, SAP)
• Therapy area training
• Clinical development planning
• Protocol and project-specific safety training at investigators meetings
• Medical /safety monitoring 24/7 coverage
• Project-specific medical monitoring manuals / safety monitoring manuals / safety reporting plans according to country-specific regulatory requirements
• Handling medical queries from sites or ECs regarding appropriate interpretation and application of the study protocol, including advice on emergency management and dose titration
• Assessing subject eligibility
• Medical review of data listings
• Review of medical coding data
• Literature evaluations
• Preparation of CTD Module II
• Expedited reporting of SAEs
• AE and SAE logging, tracking, MedDRA and WHO-DD coding, case processing and distribution to stakeholders
• Individual case safety reports
• Aggregate report writing
• Periodic safety updates
• Development safety update reports
• Concise safety analysis and benefit-risk evaluation
• Annual safety reports or clinical safety reports
• Risk evaluation and mitigation strategies