GAP offers a wide range of Medical Writing and Document Publishing solutions to support various clinical study documentation needs. GAP’s Medical Writers can assist in the clinical trial protocol writing at any point in the product development lifecycle across Phase I to Phase IV.
The developed protocol incorporates the accompanying guidelines:
Cover sheet (General Information),
Determination and Exclusion of Subjects, Treatment of Subjects,
Evaluation of Efficacy, Evaluation of Safety,
Suspension of the Study, Facts, Quality Control and Assurance,