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Medical Writing, Publishing & Submissions

The CTI Medical Writing team is comprised of experienced individuals with advanced degrees including PharmDs, MDs, and PhDs. We routinely prepare Investigator Brochures (IBs), protocols, Integrated Summary of Safety (ISS), Integrated Study of Efficacy (ISE), general medical writing, Clinical Study Reports (CSRs), and systematic literature reviews as part of our work with sponsors around the world. Our medical writers work collaboratively with our functional departments including Medical Affairs, Regulatory, Biostatistics, and Clinical Trial Operations in order to ensure regulatory documents are developed to be scientifically, methodologically, and operationally sound.

Regulatory Submissions & Applications

CTI’s has continued proven success in numerous approved drug and device applications. We have more than 100 drug approvals in our history.

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eCTD Publishing

CTI has the expertise needed to help our sponsors understand and comply with document submission requirements.

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Clinical Study Reports

We work closely with sponsors to ensure accurate data presentation and interpretation, strict adherence to regulatory guidelines, and sponsor requirements.

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