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MedSci Consulting and Excellence™

OCT Clinical Science and Medical Writers are in constant demand in various fields, in order to generate well-written documents and manuscripts that abide with the regulatory bodies and the publication standards. We are extremely proud of the team of our in-house experts, who are members of the European Medical Writers Association (EMWA). These top-notch professionals demonstrate vast expertise in a variety of therapeutic areas and indications.

In addition to the deep knowledge of clinical and medical questions, OCT medical writers are deeply immersed in all regulatory requirements and can guarantee compliance with both local and international regulatory requirements.

OCT medical writers perform medical, scientific and regulatory writing, consulting as a standalone service as well as a component of the CRO services provided within a turn-key project. Documents designed by our medical writers are study protocols, investigator brochures, informed consent forms, preclinical reports, clinical study reports, registration dossiers, scientific articles.

Clinical Study Report
Investigational Brochure
Informed Consent Form
Study Design
Review of Case Report Form
Final Study Report
Safety Narrative
Patient Information Leaflet
CTD Modules
Pharmacovigilance Documents
Sample Size
Responses to Regulatory Authorities
Interim Study Report
Preclinical Study Report
Scientific Articles
Clinical Study Design Preparation

Proper clinical study design preparation is an essential step in every clinical research program. We approach every project with a clear understanding that careful planning and detailed foresight is crucial for a successful study. With that in mind, it is critical to optimize clinical trial design in order to deliver according to the plan. Due to our vast experience of over 15 years, we can anticipate most of the risks and pitfalls at the study design development stage.

Sample Size Determination
Regulatory Writing (regulatory documentation)
Scientific Writing
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