Axio will safeguard the integrity of your data—and deliver responsive, intuitive data management solutions
// 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.
Clinical Data Management Systems
You can count on Axio’s adherence to the highest data management standards. Our personnel follow standard specifications, and collaborate with in-house biostatisticians and SAS programmers in designing case report forms (CRFs) and databases. We design our CRFs and databases with an eye to how these elements affect your downstream processes. Your study’s processes for data extraction and preparation are designed to make the database useful for SAS analyses.
Prior to study start, we will work with your team to identify key areas for edit checks and cross-form checks. To support your team’s decision-making activities, we will customize data metrics and study management reports to your needs.
Paper Studies: For paper-based studies, we will build and maintain your clinical database using Clintrial (Phase Forward). After CRFs are final, the database is typically ready for data entry in two weeks, while edit checks are programmed and validated in approximately four weeks.
Electronic Data Capture (EDC) Studies: Axio has over 15 years of experience with EDC. To further upgrade our EDC capabilities, we partnered with BioClinica in 2010 to adopt their Express EDC solution and Merge in 2013 to utilize their eClinical OS platform. Our staff have also used Medidata Rave for NCI-supported trials.
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.
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.
For studies that require highly complex data management solutions, we have answers. Axio’s data management experts have successfully built custom systems for many companies. Here are some examples:
- Creating a web-based application to track the incidence, reporting, and follow up of SAEs. This encompassed ongoing cross checks with CRF data, generating reports that included both CRF and safety data to assist with the preparation of narratives, and generating real-time reports that enabled clinical sites to see discrepancies between safety data and CRF data.
- Developing an MRI scan tracking system for remote readers to grade scans and communicate with site personnel if and when scan results indicated a problem.
- Incorporating lab data transfers and scan reading center data to study databases. Because of our deep experience with mid-study DMC reports, we excel at detecting and scrubbing unclean data coming from disparate sources. We have validated macros for easy lab unit conversions and common terminology criteria for adverse events (CTCAE) grading.
- Creating web-based custom patient randomization schemes based on algorithms generated by our biostatisticians. Simple or adaptive designs, with or without blocks or strata, are all within our capabilities
Axio’s data management team developed a Survey Tool as part of our support of several large ongoing registries, along with electronic patient-reported outcomes (ePRO). This tool features customizable edit checks and web-page formatting, options for double data entry, cross-browser compatibility, and extraction of data to SAS. The Survey Tool has been used in more than a dozen applications, including surveys of clinical practitioners, patient symptom diaries, and medication experiences.