Study Start-Up

Study Start-Up

LSK Global PS helps to advance the project schedule by simultaneously mobilizing manpower specialized in the fields of project management, site start up, and clinical research operation to manage the time in the preparatory phase prior to start up a study efficiently.

Study Start up

- Project Manager
The project manager generally directs the project teams so that the activities to be prepared at the project level by each team can be discussed and carried out in line with the timeline.
- SSU Team
The specialists and managers who are wholly responsible for the SSU tasks carry out the study start up services prior to study initiation including feasibility review, IRB’s initial review, and initial contracts with study sites in a dedicated manner.
LSK Global PS can provide services in a prompt and efficient manner since it has a good grip of the information on subjects, documents to be submitted to the IRB, and progresses at each study site through the database established from the experiences in diverse clinical studies. In addition, LSK Global PS maintains an amicable relationship with a person in charge of the IRB of each study site and can help the prompt selection of subjects and proceed with the approval from the IRB within the planned schedule.
- CRM / CRA
LSK Global PS carries out tasks with the relevant teams organizationally to allow the prompt initiation of subject enrollment once the IRB’s approval is obtained by arranging what should be prepared for the PSSV and SIV in advance.

Process

Service Scope

Feasibility (Site/Investigator Selection)

Pre-study site visit

Initial IRB submission study budget negotiation with site

Clinical trial agreement

Experience

Study Types

80706050403020100 Phase I Phase II Phase III Phase IV IIT PMS Observation Study Medical Device Others

Therapeutic Area

276 Projects (Updated on 2019.12.31) Oncology Cardiovascular Endocrinology Ophthalmology Neurology Gastroenterology Orthopedics Psychiatry Hepatology Plastic surgery Others