The medical writing division at GCE started in 2017 with a team of experienced regulatory and publication writers having an average experience of more than 12 years. The writers are from multidisciplinary background ranging from paramedical sciences (pharmacology, biotechnology, microbiology, genetics etc.) to medical qualified doctors, thereby providing an additive advantage to deliver high quality deliverables across multiple therapeutic domains.
The medical writer plays a key role during every stage and phase of clinical trial. Our team owe the competency in preparing the following documents (Table below) across different therapeutic areas, including oncology, microbiology, cardiovascular, ophthalmology, gastroenterology, musculoskeletal disorders, autoimmune disorders, medical devices, vaccines, metabolic disorders, nutritional disorders, renal disorders, neurology, respiratory disorders and women health.
Table: List of Deliverables
|Protocol +Amendment(s) + summary of changes to the protocol, including BA/BE protocols||Original research articles|
|Informed consent document||Review articles|
|Investigator brochure||Case reports|
|Clinical study report||Systematic reviews and meta-analysis|
|Integrated safety summary||Slide decks and posters for conference|
|Periodic safety update report||Conference abstracts|
|Development safety update report||One-page manuscript summaries|
|Patient safety narratives||Newsletter|
|Clinical trial summaries||Submission to journal and address comments from external reviewers and journal editor|
Besides providing the services for high quality deliverables, the medical writing team is also actively involved with Document deidentification and Anonymization.
We also provide standalone services for quality check of different types of documents using in-house validated quality check templates. We have highly robust standard operating procedures for all of our deliverables, which helps us to deliver quality documents beyond client expectation.
Within a year, medical writers have successfully delivered over 30 projects with high client satisfaction and had gained repeat business. Every document we prepare undergoes a rigorous review and robust quality check to ensure that the document reaching the client meets the industry standards.
Our team works collaboratively (as required) with different teams on both the client side and inside all GCE departments during the process of producing documentation. Our handpicked GCE professionals are also typically dedicated to one client at one time, so they do not lose track of materials, deadlines, and project goals.