Epidemiological Research for PMS / OS

Epidemiological Research for PMS / OS

LSK Global PS has been providing professional services for the entire process of the post-marketing observational study including the rPMS(regulatory Post-Marketing Surveillance/reexamination study), observational study(prospective and retrospective studies), and survey by establishing a department dedicated to the tasks for epidemiological research in 2010.

rPMS by Korean pharmaceutical affairs law

Observational study without intervention

  • Safety study
  • Drug utility research
  • Efficacy study
  • Database research
  • Survey
  • Chart review study

Professional Data Analysis

An epidemiological research requires more experiences and statistical knowledge than clinical studies in terms of the statistical data analysis, since it has a problem with the bias and confounding which cannot be found in clinical studies, and its quality control of the data is limited in particular. LSK Global PS has more distinctive strengths in designing and data analysis of the epidemiological research through the unified management of statisticians and epidemiologists.

Smooth Subjects Enrollment and Project Management

LSK Global PS has come to develop the know-hows of smooth subjects enrollment through the conduct of PMSs in the field of various diseases for many years and the Project Lead who has a good understanding of the field operations manages a project in an efficient and active manner through a smooth communication with the relevant departments and authorities.

Process of RMP(Risk Management Plan)




Process of rPMS

Service Scope

RMP development

Protocol development

eCRF development

Data management

Statistical analysis

Project and site management

  • PSSV (Pre-Study Site Visit) : Site qualification visit
  • Site contract support
  • Site staff training
  • Site payment support
  • IRB submission
  • Site initiation visit
  • Document management
  • Interim monitoring visit
  • Investigator meeting
  • In-house monitoring by EDC
  • Query resolution
  • Close-out visit

Reporting

  • Study report for NIS
  • Annual report for rPMS
  • Reexamination report for rPMS
  • PBRER for rPMS

Experience

Study Types

100806040200 PMS Observation Study Epidemiology

Therapeutic Area

167 Projects (Updated on 2019.12.31) Cardiovascular Oncology Endocrinology Neurology Infectious Disease Gastroenterology Dermatology Respiratory Medical Genetics ENT Others