Medical Writing
Genpro has a pool of medical writers and medical coders with several years of experience across various therapeutic areas. Our consultants are trained on ICH E3 guidelines and work very closely with our US team of statisticians and medical writers. Genpro uses medDRA dictionary for coding Adverse Events and Medical History data while the WHO-DD dictionary is used for coding Concomitant Medications.
Work Flow
CLINICAL STUDY REPORTS
ICH E3 Compliant Clinical Study Reports.
Genpro Medical Writers will work with your team of data managers, statisticians and trial designers to align with the scope of the study. We will use our expertise to guide you through your clinical data and display the efficacy of your drug and improve patient safety. Our team of medical writers has experience across multiple therapeutic areas and consists of a good mix of physicians and academicians. All our reports go through a thorough statistical review before being delivered to the customers.
CRF MANUALS
Detailed Manuals for EDC data entry.
Genpro content writers will work with your team of data managers and clinical data coordinators to create EDC manuals which will help the sites to enter the data with ease. The manuals are later put through a thorough quality check which will validate the contents and usability of the manuals.
CASE STUDIES
Specific case studies around particular diseases and molecules.
Genpro medical writers will work your clinical team in order to develop specific case studies against newer trial designs or novel molecules that you might want to present before your customers and present in conferences.
POSTER DESIGN
Posters for Conferences and Summits.
Genpro team of designers and content writers will generate posters that will encapsulate your study findings in the most intuitive manner so that your study will be well received in the international conferences and summits.
MANUSCRIPTS
Manuscript for Publication in a Biomedical Journal
Genpro medical writers will work for your team of data managers and clinical data coordinators to generate manuscripts stipulated by the target journal.
PATIENT NARRATIVE
Patient narrative for regulatory submissions or evaluation of the safety profile
Genpro medical writers will work for your team of data managers, statisticians and trial designers to generate the patient narratives. Our team of medical writers has experience across multiple therapeutic areas and consists of a good mix of physicians and academicians. All our reports go through a thorough statistical review before being delivered to the customers.