Rigor and reliability.
Axio’s clinical data management team delivers solutions that address all aspects of the clinical trial process—from protocol development though report writing—with uncompromising accuracy and adherence to the highest data management standards.
Our work pivots on industry-recognized and FDA-compliant data management systems that enable us to deliver high-quality output with confidence.
Our team applies extensive data management experience spanning preclinical through Phase 4 development as well as a broad range of therapeutic areas, using both paper and EDC systems.
To facilitate decision-making, we customize data metrics and study management reports to client needs.
Axio’s Integrated Data Management Solutions include:
- CRF design
- Database specification, programming, and validation
- Data management plan development
- Query management
- Medical coding
- Data integration
Representative Studies
| Indication | Phase | # Patients |
| Atrial Fibrillation Therapy | 3 | 4,100 |
| Coronary Events Study | 4 | 4,000 |
| Hyperlipidemia | 4 | 3,400 |
| Personalized medicine and lab-developed test | 4 | 2,300 |
| Anemia | 3 | 750 |
| Cystic Fibrosis | 3 | 350 |
| RSV Vaccine | 3 | 300 |
| Rheumatoid Arthritis | 2 | 226 |
Data Management
At Axio, we provide data management solutions with speed, flexibility—and uncompromising accuracy. You will work with project directors who have, on average, 10 years of data management experience. They are supported by a highly capable and creative team of data coordinators and programmers.
Our data management personnel are involved in Clinical Data Interchange Standards Consortium (CDISC) activities and are members of the Society for Clinical Data Management (SCDM). Well versed in a significant array of data sources, they bring to our team extensive experience in a range of scientific disciplines.
ADVERSE EVENT CODING
We will work with you to develop best practices in creating coding guidelines and conventions. Our services include preparing a detailed plan for your study that addresses:
- How to code procedures properly
- Defining protocols for coding symptoms versus diagnoses
- MedDRA versioning over time
- Under what circumstances to query the sites about adverse events
You can depend on fast turnaround times and a flexible, client service-oriented team.
DATA STANDARDS
Axio is a corporate member of the Clinical Data Interchange Standards Consortium (CDISC); our staff members have been trained in the Study Data Tabulation Model (SDTM) and Analyst Data Model (ADaM) standards. In addition, our data management team members are active participants in the SDTM, ADaM and Clinical Data Acquisitions Standards Harmonization (CDASH) standards groups. We have assisted clients in creating CDISC/SDTM data sets from their clinical data and have conducted training for biotechnology companies in CDISC/SDTM.
Based on our experience, it is most efficient to keep the CDISC naming standards and domain structure in mind as the study database is developed, but not to attempt building the clinical database in the SDTM format. After the data are extracted from the clinical data management system, the SDTM data sets are created. We have developed mapping tools to ensure that all data are treated appropriately. These mapping tools become the metadata describing the SDTM data sets in relation to the study CRFs.
