Our experienced regulatory professionals are committed to offering superior quality regulatory services to ensure product development runs efficiently and effectively and clients maximize opportunities. Our service portfolio ranges from chemical products including NCE(New Chemical Entity), IMD(Incrementally Modified Drug) and Generics to biologicals.
- Strategic and Regulatory Drug Development Consulting
- Preparation and Document Validation of Registration Dossier
- IND & NDA Application Support
- Scientific and Medical Communication with Regulatory Authorities
- Post-Approval Maintenance Support
2. Clinical Operation
Our Clinical Research Associates (CRAs) and Managers (CRMs) have a variety of global and local study experiences. We are also thoroughly trained in ICH-GCP and KGCP guidelines. Our services include:
- Protocol and CRF Development
- Investigator and Site Selection
- Feasibility Study
- Dossier Develop & Translation
- Site Qualification Visit
- Site Initiation Visit
- Interim Monitoring Visit
- Close-out Visit
- Site Management
- CSR Writing
We offer clinical trial-related services that meet global standards throughout the entire clinical trial process. We can help you reduce risks, costs and the likelihood of delays for accurate timelines and lead you to success.
3. Project Management
To draw the best project performance and to be optimized on our client`s needs, we provide Project Management Plan. This includes:
- Site Management
- Project Management
- Vendor Management
- IP Management
- SAE Management
- Document Management
Your success is our sole mission. Our passionate and talented teams of experts help you make faster, better decisions on every step. And we are trying our best efforts to improve the quality and efficiency in each project.
4. Quality Assurance/Audit
Our QA Department thoroughly abides by GCP to provide audit service to sponsors. And we are consistently conducting internal audit ourselves to improve our service quality.
- Contracted System Audit
- Contracted Site Audit
- Contracted In-house Audit
- Internal Audit (e.g. for cause, TMF audit etc.)
- Preparation and Training for the Inspection
- Professional Training for Clinical Trial
5. Post Marketing Surveillance
Our PMS experts provide the most optimized services to meet the specific and varied needs of clients in accordance with the latest regulations and guidelines for PMS. We support clients to obtain reliable safety data through efficient study design and project management.
- Protocol & CRF Development
- IRB Submission
- Site Contract
- Investigational Staff Training
- Project Management
- Safety Report
- Periodic and Re-examination Report Writing
6. Data Management
ADM Korea will be provide high-quality and cost-effective services to ensure the successful management and delivery of clinical trial data
· Compliance with Regulations ICH guideline, 21 CFR Part 11 and KCGP
· With Expert Data Manager, Database Programmer, CRF Manager, and Data Coder
- We will be provide as following services:
· Data Management Plan Development
· Customized Database Design and Validation
· Double Independent Data Entry and Unmatched Check
· Data Validation and Check Report
· Data Review Listings for study whole data
· Medical Coding (MedDRA, WHO ART, WHO ATC)
· SAE Reconciliation
· Data Quality Reviews
· Electronic Data Transfer
· Back-up and Security
7. Statistical Analysis
ADM Korea’s Biostatisticians comply with GCP and ICH standards such as ICH E9, Statistical Principles for Clinical Trials and we validated SAS Analysis Result System
- Statistical Consulting
· Statistical study design and sample size calculation for any phase of the drug or device development step
· Protocol & CRF Development considered for Data Management & Statistical Analysis
- Statistical Analysis Plan(SAP)
· SAP includes statistical analysis population, detailed description and table listings of all statistical analysis to be carried out on the collected data.
- Randomization Code Generation utilizing SAS software
· Web based Randomization (IWRS) will be provided by ADM Korea.
- SAS Software programming for Result and Output
· ADM Korea will be generated by biostatistician and validated by independent biostatistician.
8. EDC Solution Service
Solutions developed & provided by CRScube, a leading provider of e-CRF solutions(www.crscube.co.kr) and ADM Korea Inc.