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Clinical Trial Management
Clinical Trial Management
Clinical trial project management can encompass the entire scope of a clinical trial, from trial site identification and qualification to closing out all vendor activities. Clinical Research Organizations (CROs) offering project management services could cover clinical trial monitoring, regulatory submissions, clinical data management and medical writing services. Depending on the types of products being tested (e.g. prescription or OTC drugs, medical devices, biologics, etc.) or the therapeutic areas of interest (e.g. Neurology, Oncology, Women’s Health, etc.) , a variety of team will need to work in an orchestral manner to make things happen.
Study Set-up Activities
Study Set-up Activities
Feasibility study assessment
Literature review and meta-analysis
Clinical Study Design and Protocol Development
Statistical planning and sample size estimation
IRB regulatory submission, CTA/NDA review
Case Report Form development
Study Conduct Activities
Study Conduct Activities
Placement of study coordinator (SC)
Site Initiation (Site and investigator selection / Site initiation / Site personnel training)
Project Management (Clinical Research Associate services / Study coordination with study sites, sponsor and study related vendors / Management of deliverables and progress reports / Serious Adverse Events reporting)
Study Monitoring
Study Monitoring
Site monitoring visit (Source data verification / Monitoring of patient eligibility and enrolment into the trial)
Study Closeout visit
Post Study Activities
Post Study Activities
Design of the data management plan based on project
Data management requirements and SOPs
Evaluation of clinical data consistency
Site data query
Case Report Form data entry, retrieval and management
Data security management and document archiving
Manuscript / Medical writing
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