Our medical writers have strong scientific knowledge in most major therapeutic areas and develop clinical study design and protocols, document clinical study reports in compliance
with guidelines such as MFDS, FDA, ICH-GCP/KGCP and EMA.
We offer medical support, in close collaboration with our Clinical Operation, Biostatistics and Data management teams to ensure high-quality data and on-time reporting of study deliverables.
ADM Korea provides excellent clinical trial-field service in the global standards of all the phases, serving the best quality that has reduced risk and the cost within your desired project milestone.
1) Comply with ICH-GCP and KGCP guidelines.
2) Have extensive global and local clinical research experience.
3) Have a high quality of infrastructure.
Serving the best quality and speedy- progress throughout the Proactive Risk Management and Issue & Quality Management by the experts over 10 years careers in the fields of clinical trials.
Serving the professionalized Clinical Monitoring and Site Management Services by CRAs perfectly trained by CRA Line Managers practice accredited internal Clinical Trial Monitoring Education Courses and CRA Training Programs.
Serving the best clinical trial set-up with the prompt systematic plans by the specialized team that has wide experience with the diverse Clinical Trial Sites.
Carrying out regular Quality Controls for qualifying the projects to be complied with protocols, SOPs and GCPs by project-QC visits of specialized QC team.
ADM Korea has experts with extensive experience in the operation and audit of local and global projects and various therapeutic areas and has expertise through internal learning management systems to provide optimal service to customers based on a high level of understanding of the project.
The ADM Korea Data Management Team provides professional and reliable services from CRF Development, Clinical Trial System Set-up, Data Management, Centralized Statistical Monitoring and CDISC standards based on extensive practical experience and efficient process in various Clinical Study such as Post Marketing Surveillance and Medical Devices as well as clinical trials and therapeutic area. Especially, personnel with experience in R&D of clinical trial solutions provide qualified service by performing EDC Build and Data Validation Programming using C# and SAS Programming.
(Clinical Data Management System:
- CRScube: cubeCDMS, cubePRO
- Medidata: Rave EDC, RTSM, eCOA)
The ADM Korea Biostatistics Team provides professional and reliable services from Study design, Sample size Calculation, Randomization, Statistical analysis plan, statistical Analysis Result, Statistical Analysis Report to CDISC standards based on extensive practical experience and efficient process in various Clinical Study such as Clinical Trial, Post Marketing Surveillance and Medical Devices, etc. and therapeutic area.
ADM Korea offers superior quality regulatory services so that product development can be carried out efficiently and effectively. ADM regulatory experts with experience in a variety of fields from the initial development of pharmaceutical/medical device to approval and high regulatory understanding suggest the proper regulatory strategy to help clients register product efficiently.