At Confidence, our primary objective of medical writing is to ensure that these documents are scientifically accurate, clear, concise, and meet regulatory requirements.

Working closely with our Regulatory specialists and seasoned trialists, we produce ICFs that fulfill the requirements of multiple Regulatory bodies and Ethics committees.

A well-designed study protocol is a crucial element for any successful clinical trial. It should establish clear scientific objectives and provide a comprehensive understanding of the therapeutic field, while ensuring a justified sample size, well-defined inclusion/exclusion criteria, and adherence to strict regulatory requirements. In addition, it’s vital to develop Informed Consent Forms (ICF) that meet the specific requirements of regulatory bodies in different countries, whether for conventional clinical research settings, pediatric research, or research involving acute patients where consent must be given by a surrogate.

At Confidence, our primary objective of medical writing is to ensure that these documents are scientifically accurate, clear, concise, and meet regulatory requirements. 

Confidence medical writers have experience in development of the study protocols in different therapeutic areas and in different study phases. In cooperation with regulatory specialists and experienced trialists, our medical writers develop ICFs which meet the requirements of multiple regulatory bodies and ethics committees.