Data management is a central role in Clinical Trial to ensure data collection according medical expectations and enough data cleaning to allow statistical perspectives.
Trained people according processes regulatory DM aspects
Data Management is strictly framed by an important legacy and regulatory processes. Aixial Group’s data manangement teams are compliant with:
21CFR part 11
ICH 6 and 9
Data Management Capabilities
Designer team can set-up all kind of CRF/eCRF designs especially the most complex one in order to be aligned with protocol specificities (several arms, dose escalations…). Our Designer can work on several EDCs and are regularly trained at each tool release and/or when new tool is required by clients.
Our team is able to perform all data entries for entire clinical trial. In eCRF context this entry is now more for paper back-up form but we continue to train our team to keep a very good level of data entry quality. We are also able to train all monitoring teams and/or investigator in order to have a good level of CRF completion quality. In accordance with CCG and client expectations.
Programmer team is able to provide a complex programming for edit checks but also for all validation listings, export tables… Several programming languages mastering allow our team to make very complex and reliable programs.
Data cleaning and validation
Our very strong and experienced DM team ensure a thorough data cleaning in order to have a ready database for statistical analysis and answered to all medical aspect provided per protocol.
Data project management
Project Manager will handle entire project aspects with resources, budget, planning management in order to have timelines meet and all study objectives targeted.
We provide Data Management solutions and support along clinical trial life. Our expertise in all therapeutic areas and our experience to manage people around the world allow us to work with all client types from big pharma to little biotech or providers. Aixial accompanies clients to find the best option according their expectations, projects, contraints and budget.
Laurie, Data Management expert
Our delivery methods
Technical support, advice and expertise
A range of services dedicated to your activities driven by our team
Performance with commitment to results
Aixial Group around the world
Aixial Group can help you around the world. We provide services onshore, nearshore, and offshore to ensure that your solution is customized to your specific needs.
Biotech & Vaccines
How can we support your next project?
OTHER WAYS WE SUPPORT YOU