InCROM CRO Inc.
Featured Services
- ■ Speedy and high-quality service by well-experienced staff
- ■ Data Management of Case Report Forms for various medical institutions
- ■ Statistical and PK/PD Analysis using SAS software which satisfies the demands of our customers
- ■ Preparation of Study Protocol and Clinical Study Report based on wealth of experience
- ■ Consistent Quality Control and Quality Assurance from Monitoring, Data Management to preparation of Clinical Study Report
- ■ Up-to-date Clinical Trials such as QT/QTc, biosimilar, and microdose studies
- ■ One-stop service from consultation to GCP Audit
- ■ Other tasks as requested by clients
Work Contents
■ Clinical Monitoring Service and GCP Audit
- Confirmation of required conditions of Principal Investigators and Sub-Investigators
- Confirmation of required conditions of Responsible Medical Expert
- Request clinical trials to medical institutions and response to IRB Review
- Explanation to Investigators and CRC staffs
- Management of Essential Documents
- Monitoring
- GCP Audit of Study Sites and CROs
■ Data Management (DM)
- DM Plans
- Database Design
- Data Entry/Validation
- Manual/Logical Check
- Database Locks
■ Statistical Analysis (SA)
- SA Plans & Production of SA Reports
- Subject Data Listings
- Production of Figures & Tables
- Document Preparation for Case Review Meetings
■ Medical Writing (MW)
- Protocol (Draft)
- Case Report Forms (Draft)
- Informed Consent Forms (Draft)
- Investigational Brochures (Draft)
- Clinical Study Reports (Draft)
■ CDISC (Clinical Data Interchange Standards Consortium)
- CDASH (Clinical Data Acquisition Standards Harmonization)
- SDTM (Study Data Tabulation Model)
- ADaM (Analysis Dataset Model)
■ EDC/CDMS
- Medidata Rave
- Viedoc
■ Others
- Support of academic articles
- Translations (English)
- Consultations for clinical study design, etc.