Medical Writing

EPT Servicios Científicos provides the support needed to write, edit and produce scientific documents related to conduction and follow-up of Clinical Trials, Pharmacovigilance activities, support to Departments such as Marketing and Sales, Registry, Quality Assurance, and Editorial support.

This includes writing Protocols, Clinical Reports, Periodical Safety Reports (PSURs), Standard Operating Procedures (SOPs), Product Monographs and Scientific Manuscripts among others.

Clinical Trials

– Writing Protocols and Amendments
– Writing Case Report/Record Forms (CRFs)
– Writing Investigator’s Brochure
– Investigators Meetings
– Writing SOPs
– Presentation of abstracts, posters and oral communications
– Presentation of results for investigators
– Publication of results and writing scientific manuscripts

Pharmacovigilance

– Management and control of Adverse Events / suspected Adverse Drug Reactions
– Writing SOPs
– Writing Adverse Events / Adverse Drug Reactions expedited reports
– Periodic Bibliographic search
– Writing Periodic Safety Update Reports (PSURs)
– Writing Expert Reports
– Writing Drug Benefit / Risk analysis report
– Writing Post-marketing study reports

Support to Marketing and Sales

– Writing Product Training Manuals for Sales Network
– Preparation of Presentations
– Writing Product Monographs
– Writing Product Technical Information Questionnaires
– Writing manuscripts
– Promotional Material Review
– Writing scientific brochures

Editorial Support

– Writing scientific manuscripts
– Adaptation to editorial guidelines
– Publication in national (Spanish) and international (English) journals
– Style and orthography review
– Writing Scientific contents of web pages

Quality Assurance

– Writing manuals and guidelines
– Writing SOPs
– Writing Audit Reports

Registry

– Writing Expert Reports
– Writing and adaptation of Technical Dossiers