Data Management

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:

GCPs

21CFR part 11

ICH 6 and 9

CDISC

EMA/FDA/MHRA recommandations

Data Management Capabilities

Database Design

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.

Data entry

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.

Data programming

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 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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