Clinical Research (CR)
Our support in clinical research studies:
(eg. clinical trials, epidemiological studies, survey studies)
DESIGN
Proposal & Plan
- Design of study plan
- Study design consultation
- Design of allocation plan
- Sample size estimation
- Support for protocol development
- Preparation support for informed consent documents
- Application support for ethics committees
DATA COLLECTION
Study implementation
- Study office
- creating study-related documents
- convening kick-off meetings and interim review committees etc.
- support for participating healthcare institutions
- forming implementation teams
- arrangement of site initiation meetings
- responding to inquiries
- patient enrollment and allocation
- study progress management
- Central data monitoring
Data management
- Data management (DM)
- design of case report forms (CRFs)
- creating DM plans (DMPs)
- data input
- coding
- manual check & logical check
- issuing queries
- data lock
- writing DM reports (DMRs)
- System development
- electronic data capture (EDC) systems
- allocation systems
- other databases
ANALYSIS (Data analysis / Reporting)
Data analysis
- Design of statistical analysis plan
- Writing statistical analysis plans (SAPs)
- Implementation of analysis
- Creating statistical analysis reports (SARs)
- Consulting
Reporting
- Medical writing (manuscript writing assistance)
- Submission support
- Point-by-point response letter writing and manuscript revision support
- Support for conference slide creation
- Support for conference poster creation
- Consultation