• Clinical Protocols

 

• IMPDs

 

• Non Clinical/Clinical Summaries and Overviews (Modules 2.4, 2.5, 2.6, 2.7)

 

• Scientific advice for the formulation of research protocols

 

• Preparation and review of scientific documents in response to Regulatory Authorities; deficiency letters

 

• Clinical Trial Applications to local and national Regulatory Authorities

 

• Investigator’s Brochures

 

• Clinical Trial Reports

 

• Journal Papers («ghost writing»)

 

• Contacts with key opinion leaders

 

• Manuscript preparation/review

 

• Selection of journals

 

• Formatting and submission

 

• Summaries and overviews