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STUDY MANAGEMENT

Effective management of clinical studies is critical to help ensure study completion on-time and within budget. Challenges include compliance with country-by-country requirements; selecting suitable study sites which meet sponsor expectations and recruitment targets; managing study conduct to help avoid protocol deviations; and ensuring adverse events are properly assessed and reported.

Whether the study is single site or multi-site, multi-country, Donawa Lifescience Consulting can assist with the following:

• Recruiting clinical sites and investigators that minimize the risk of non-compliance and patient recruitment shortfall
• Communications with Ethics Committees and clinical facility management
• Clinical study applications to Competent Authorities
• Review of study documents to ensure compliance with local requirements
• Translations of necessary study documents (eg: informed consent) into local language
• Assistance with obtaining quotations for patient liability insurance
• Investigator and site training to ensure protocol and regulatory compliance
• Study progress reports/newsletters for investigators
• Site supervision, monitoring and support throughout the study
• Drafting and sending adverse event reports
• Management of any miscellaneous administrative issues
• Drafting or reviewing final study reports

 Please contact us for further information or assistance.