Medical Writing

Medical Writing

LSK Global PS develops and provides ethical and scientific protocols for various studies including phase 1∼4 clinical studies on medicinal products and clinical studies on medical devices, human studies of health functional foods, observational studies, and post-marketing surveillances. After a clinical study is completed, LSK Global PS also prepares the clinical study report including the considerations on its statistical analysis results and clinical implications.

Designing of Ethical and Scientific Clinical Studies

LSK Global PS is staffed with medical writers having a master’s or higher level of education with a broad spectrum of experiences in clinical studies on various diseases and managers with at least 10 years of experience in medical writing in average, who develop clinical study designs and protocols cooperatively, and expert statisticians who calculate the number of subjects and prepare the statistical analysis plans. They provide high-quality study designs and statistical methodologies through close communication with the internal teams such as Statistical team, Clinical team, and Data Management team.

High-quality Service complying with domestic and foreign Regulations and Guidelines

LSK Global PS prepares protocols, ICFs (Informed Consent Forms), CSRs (Clinical Study Reports), and CTDs (Common Technical Documents) in compliance with the regulations and guidelines of the ICH, FDA, and MFDS of which the quality control (QC) and reviews are carried out by the medical writing manager, and provides high-quality outputs in which medical knowledge and evidence have been reflected through consultation with its affiliated medical doctors, as needed.

Process

Protocol development

  • Study assignment
  • Discuss with client
  • Research the paper
  • Develop the protocol Synopsis
  • Internal review
  • Client review
  • Develop the protocol
    Protocol finalization
  • Internal QC & review

CSR development

  • Study assignment
  • Writing the CSR
    CSR finalization
  • Internal QC & review
  • Client review

Service Scope

Protocol development (Korean, English)

ICF (Informed Consent Form) development

CSR (Clinical Study Reports) (Korean, English) development

CTD (Common Technical Document) module 2.5, 2.7, 5 development

Experience

Protocol (Study Types)

100806040200 Phase I Phase II Phase III Phase IV IIT PMS Observational Study Epidemiology Others

Protocol (Therapeutic Area)

Oncology Cardiovascular Neurology Ophthalmology Endocrinology Orthopedics Gastroenterology Infectious Disease Vaccine Hepatology Respiratory Dermatology Others Plastic surgery Rheumatology 346 ProjectsUpdated on 2021.06.30

CSR (Study Types)

120100806040200 Phase I Phase II Phase III Phase IV IIT PMS Observational Study Epidemiology Others

CSR (Therapeutic Area)

Oncology Cardiovascular Endocrinology Neurology Orthopedics Gastroenterology Ophthalmology Vaccine Infectious Disease Hepatology Others Respiratory 389 ProjectsUpdated on 2021.06.30