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Pharmacovigilance – Clinical Trial writing

A clinical program’s success depends on:

Proper documentation of clinical research plans
Protocols and CSR
Proper documentation of source information

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),
Foundation Information,
Study Design,
Determination and Exclusion of Subjects, Treatment of Subjects,
Evaluation of Efficacy, Evaluation of Safety,
Unfavorable Events,
Suspension of the Study, Facts, Quality Control and Assurance,
Morals, Information Assurance and Record keeping,
Production Policy, Venture Timetable/Flowchart,
References and Supplements/Appendices.