Medical Documentation

We write reviews and summaries of preclinical and clinical trials – modules 2.4-2.7 in the CTD format (EEU), we also compile modules 4 and 5 and write SPCs. We can prepare CT reports according to the EEU requirements. We prepare protocols, synposes, IB, VIL/PILs, diaries, questionnaires, patient cards and all other types of documents required for CTs. We do medical writing.

Our services
We write reviews and summaries of preclinical and clinical trials – modules 2.4-2.7 in the CTD format (EEU), we also compile modules 4 and 5 and write SPCs. Reviews contain scientific publications with results of preclinical and clinical trials of medicinal products for the specific INN, including post-marketing experience.

In CT reports we collect and analyze all safety and efficacy data for the completed clinical trial and provide them in strict compliance with relevant EEU requirements.

We prepare protocols, synposes, IB, VIL/PILs, diaries, questionnaires, patient cards and all other types of documents required for CTs.

Data Management and Biostatistics
We prepare FSA, statistical reports, randomization lists and other project-relevant documentation.

We perform expert assessment of statistical aspects of the CT documentation.

We develop and deploy eCRF on our own software platform

We perform database grooming.

Experience in Medical Writing
>400

Literature Reviews and IBs
>200

Protocols and Synopses
>100

Effective Reports on Completed CTs

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