Data Management

Data management plays a central role in clinical trials, as it ensures that data is collected in accordance with medical expectations and that it is sufficiently clean for statistical analysis.

Trained people according to processes regulatory DM aspects

Data Management is strictly framed by an important legacy and regulatory processes. Aixial Group’s data management teams are compliant with:

GCPs

21CFR part 11

ICH 6 and 9

CDISC

EMA/FDA/MHRA recommandations

Data Management Capabilities

Database design

The designer team can set up all kinds of CRF/eCRF designs especially the most complex ones to be aligned with protocol specificities (several arms, dose escalations…). Our Designers can work on several EDCs and are regularly trained at each tool release and/or when a new tool is required by clients.

Data entry

Our team can perform all data entries for the entire clinical trial. In the 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 investigators to have a good level of CRF completion quality. Following CCG and client expectations.

Data programming

The programming team can provide complex programming for edit checks but also all validation listings, export tables, etc. 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 to have a ready database for statistical analysis and answered to all medical aspect provided per protocol.

Data project management

The project Manager will handle the entire project aspects with resources, budget, and planning management to have timelines met 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 small 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 assistance
Technical support, advice and expertise

Platform
A range of services dedicated to your activities driven by our team

Projects
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.

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