The success of a clinical trial heavily relies on the effective interaction of all professionals involved in the project. PharmaExpert uses project management and planning to ensure safety, accurate results and kept timelines. Trial management is firmly grounded in ICH/GCP and safety is the first concern. GCP compliance and quality aspects in clinical investigations are keywords for PharmaExpert's clinical trial management.  
 

Overview about Clinical Trial activities:

• Clinical Trial applications - preparation and submission
• Center evaluation: Selection of Investigators and Clinical Sites
• Coordination of study procedures
• Monitoring; on-site monitoring to ensure protocol and regulatory compliance and timely submission of data; routine visits, initiation and closure visits
• Clinical trial documentation, Medical Writing Services: Study protocol development, Case Report File, Investigator's Brochures, Patient Diary, Informed Consent Forms, Patient Information, Monitoring Report, Final Study Report, Expert Overviews/Summaries, Literature Search & Analysis etc.
• Communication with the sponsor and regulatory authorities (including audits & inspections)
• Coordination of study closure
• Collection of accurate and verifiable data; Source data verification
• Query resolution
• Serious Adverse Events Reporting
• Quality Control, Quality Control plan to meet the essential documents, such as clinical protocol, project plan and data management plan set the standards and requirements of a clinical trial
• Investigational Medicines: Planning and management of clinical product development
• Trainings and workshops in clinical trial management