Tailored Clinical Trial Data Management with Accelagen
When it comes to clinical trials, data management practices are critical for ensuring the accuracy and compliance of study results. Leading Australian CRO, Accelagen, has built a reputation for its agile and tailored data management services that support clinical trials across various areas of therapeutic research.
As part of the company’s Data Management team, Senior Clinical Data Manager Suzanne Leong has played an essential role in supporting clinical studies by providing client specific services that ensure high quality data from collection to analysis. With nearly three years at Accelagen, Suzanne was one of the first members of the data management department which has now expanded to over 10 members. This growth has been accompanied by the development of an overarching Data Management Plan that is customized for each study.
“We tailor the data management plan to the protocol as it provides the framework of all Data Management activities throughout the study,” Suzanne explains. “Some studies may have additional elements like randomization and study drug supply, as well as electronic diaries for participants to track their symptoms, record dosing or complete patient-rated questionnaires.”
This tailored plan accounts for specific client needs and enables Accelagen to efficiently support clients across various therapeutic areas, ensuring data integrity and compliance. It allows Accelagen to manage data collection, storage, and analysis in ways that are most effective for each individual study.
Agile, Compliant, and Client-focused
Accelagen’s commitment to agility is reflected in its use of modern electronic data capture (EDC) systems which incorporate ePRO (electronic patient reported outcomes) and eCOA (electronic clinical outcome assessment) functionality thereby moving away from traditional paper-based data collection methods. Using ePRO and eCOA allows patients and clinicians to complete ratings and assessments directly into a secure, web-based platform. This process saves time, reduces the risk of transcribed data entry errors and enhances data quality.
Collaboration with sponsors is another cornerstone of Accelagen’s approach. Maintaining high standards of data integrity is critical throughout clinical trials, and Accelagen works closely with sponsors to ensure that the data collected aligns with the study’s protocol, primary endpoints and regulatory requirements.
The team also works closely with third-party vendors, such as laboratories, to reconcile data and ensure that sample results are properly reported. This level of oversight is essential in maintaining the quality and integrity of the data.
Accelagen’s data management practices not only ensure data integrity but also optimize the overall clinical development timeline. With the ability to generate preliminary data from interim database locks, sponsors can access critical data earlier in the trial, which is particularly useful for fundraising, publications, or presentations at conferences. This ability to deliver actionable data throughout the study provides clients with the flexibility to make informed decisions quickly when necessary.
A Commitment to Regulatory Compliance
Accelagen’s commitment to regulatory compliance is another critical aspect of its data management services. By adhering to internationally recognized standards such as CDASH (Clinical Data Acquisition Standards Harmonization), Accelagen ensures that its data is collected and processed in a standardized format that meets the requirements of regulatory agencies like the FDA and TGA.
“We design the database and the eCRF based on CDASH standards,” Suzanne says. “These standards make the data compliant from the point of data collection through to the analysis and ensures data is delivered in the format required for FDA submission. We regularly review the data throughout the life cycle of the study to ensure that the data is consistent and accurate so that in the end, there is reliable data to draw results from.”
The competitive advantage of operating out of Australia’s research environment, along with a wide selection of experienced trial sites, provides a strong foundation for high-quality data collection. This allows Accelagen to work with experienced sites that can meet recruitment targets and collect reliable data, which is essential for the success of any clinical trial.
Looking to the Future
Looking ahead, Accelagen continues to build on its foundation with forward-thinking innovations. Suzanne highlights the development of new tools and capabilities designed to improve efficiency and deliver even better results for clients.
“We are developing standard CRF libraries as well as standardizing our database programming so that we can efficiently implement the live database” explains Suzanne. “We’re also expanding our selection of EDC platforms and having our database programmers certified so that we can offer a variety of EDC systems to our clients.”
Additionally, Accelagen is introducing custom reporting options that allow clients to view their data in real time, helping them track key metrics and make decisions based on the most up-to-date information.
Accelagen’s dedication to providing tailored, high-quality, and compliant data management solutions positions it as a trusted partner in the clinical research space. By working closely with clients and adapting to the evolving needs of each study, Accelagen is helping to accelerate the development of new therapies and treatments.