Improving efficiency and keeping your data clean and user-friendly.
About Data Management
Our world-leading team can develop tailored data management solutions to meet your needs in line with CDISC’s ‘best in class’ information system for maximum interoperability. From manual data reviews to medical coding, EDC training, protocol input, and IMP management, Accelagen provides the highest quality management of preclinical and Phase I–IV trials in accordance with International Guidelines and the highest regulatory requirements.
In more detail
Initiation Phase
Studies often involve collecting large volumes of clinical data. During the initiation phase, we focus on building a shared understanding or ‘common language’ to improve efficiency and increase the quality and universality of our work.
Randomisation and logistics
Setting up randomisation, IP and logistics, and ePROs to manage your data
Adopting global standards
Enabling more meaningful and efficient research with a greater positive impact on global health
End-to-end services
Providing end-to-end data management services for Phase I–IV and other post-marketing commitments
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Activation Phase
Accelagen’s experienced team produces high quality CRF designs and database builds, customised to the nuances of each study and following CDASH standards, as much as practical. Our designs maintain simplicity to enable ease of data entry, SDV, and to ensure we produce quality outputs, while still capturing the necessary data.
Certified in Viedoc & IBM
Certified in Viedoc and IBM Clinical Developments, we can manage the integrity and safety of your data through a variety of different databases and technological solutions
Automated inventory management
We offer automated IMP inventory management and dispensing, integrated into your choice of EDC systems, and all reference range checks are automated
ePRO and data capture
We offer ePRO to capture data directly from study participants as well as third party data transfer specification and management
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Execution Phase
Maintaining a holistic outlook, we ensure that your data management is considered in the context of the study, participants and the site as a whole, by the execution team that consists of a CRA, data manager and statistician.
Data cleaning
Utilising automated data cleaning and programmed checks throughout each study.
Systematic approach
Any manual data cleaning follows a strict plan to ensure a thorough, systematic approach, and to increase the efficiency and integrity of the data management process.
Customised reports
We offer customised reports for data reviews, which support you to prepare for any Safety Review Committee meetings.
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Completion Phase
Closing studies out in a methodological and meticulous fashion is essential to fulfilling regulatory obligations, maintaining the integrity of the data, and ultimately to enable us to improve the lives of real people. We ensure that all study-related documentation is maintained and securely stored, that data is locked and you have a clear picture of what has been achieved.
CRF and data capture
We provide specialised CRF data, collected with expert precision and in line with study design protocols, at the completion of each study.
Database lock
Performing a comprehensive and robust database lock to secure the quality, integrity, and reliability of your valuable data.
Final quality checks
Completing any final format verifications, validity confirmations, data comparisons, and spot checking.
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Biometrics
Our team is both methodological and meticulous in closing out studies as we see this as essential to fulfilling regulatory obligations, maintaining the integrity of the data, and ultimately to enable us to improve the lives of real people. Accelagen will ensure that all study-related documentation is maintained and securely stored, that data is locked and you have a clear picture of what has been achieved.