We have developed solutions adapted to our clients’ requirements for studies in the majority of the therapeutic areas. To our clients we offer our technological know-how (Oracle® Clinical, SAS® 9.1 platform), our experience, our teams and our solutions.
Our team designs and manages eCRFs or paper clinical trial databases. It secures and optimises the data processing by using efficient management tools and quality control processes.
Our solutions and services:
- Designing Case Report Forms
- Creating the database structure with Oracle® Clinical
- Internal data entry
- Quality control at every stage: data entry, programming of validation checks, entry of queries
- Designing data management plan
- Query management throughout the study
- Loading external data
- Medical coding and review of adverse events, medical history and concomitant medications by a physician
- Writing of the data management report
- Preparation of the Blind Review
- Database lock
Keyrus Biopharma is an active member of CDISC organisation