Interventional Studies

Phase I-IV

With the completion of a significant number of projects, covering a broad range of therapeutic areas, we offer a portfolio of proven experience in Interventional Studies. Our well trained professionals are readily available to meet project needs and provide solutions, advice and local expertise. 

Services that ZEINCRO provides in the field of Interventional Studies are:

Clinical Trials Management

• Study planning & set up
• Feasibility
• Site screening & selection
• Organization & conduct of Investigator’s meetings
• Planning, budgeting & resourcing
• Trial files construction
• Submissions to IRBs & regulatory authorities
• Trial initiation
• Study conduct
• Study monitoring
• Project management
• Safety reporting
• Essential documents maintenance
• Continuous communication with investigators, regulatory authorities & IRBs
• Study close out
• Site closing
• Trial files finalization & archiving
• IRB & regulatory authorities reporting

Medical Affairs

• Concept development & evaluation
• Protocol writing, editing and reviewing
• Patient documents development
• Case Report Form design
• Study Manual development
• Safety review
• Medical support & advise during study conduct
• Translation of medical documents
• Clinical study report preparation
• Medical writing

Training

• Training courses on ICH GCP guidelines and local legislation
• CRA introductory and advanced training
• Tailor made training courses on clinical research
• Investigators’ training
• Therapeutic area specific training