Australian CRO, Accelagen, has established itself as a leader in delivering tailored, high-quality clinical data management solutions. Through a combination of certified expertise, robust processes, and advanced technology platforms, Accelagen ensures that clinical trial data is accurate, compliant, and audit-ready—supporting both local and global sponsors at every stage of the research process.
Personalised and Protocol-Driven Database Design
At the heart of the database design service is its commitment to building custom clinical data collection systems precisely aligned with each study’s protocol. Every project begins with a detailed review of the protocol, allowing the Data Management Team to identify elements that could impact data capture or usability, and opportunities that also enhance the quality of outcome. This approach ensures that the database structure supports the study’s objectives and regulatory requirements from the outset.
Accelagen’s databases are designed and programmed in accordance with industry standards such as CDASH (Clinical Data Acquisition Standards Harmonization), facilitating regulatory submissions and ensuring data integrity. Certified database builders translate complex protocols into user-friendly electronic case report forms (eCRFs), incorporating visit schedules, assessments, and automated edit checks that prevent data entry errors and flag protocol deviations in real time.
As Senior Clinical Database Developer Emma Norris explains, “We build eCRFs, the data collection forms, from that protocol, we’ll program all the visits and different dynamics within the database, and we’ll also program edit checks which are used to prevent data entry errors or to identify protocol deviations.”
These programmed dynamics and edit checks are designed to eliminate issues before they occur. Extensive user acceptance testing confirms all design parameters of the system are functioning as expected, all leading to an efficient go-live for the database.
Agile Collaboration and Client-Centric Service
Accelagen is recognised for its collaborative model, engaging sponsors early in the process through protocol reviews and discussions on incorporating Accelagen’s CDASH forms with any required sponsor-standard forms. This fosters seamless integration with sponsor teams and ensures that client needs are incorporated throughout the database build. For repeat clients, Accelagen leverages knowledge of previous database structures to streamline future studies and a faster build time.
The company’s agile approach is further demonstrated through its use of electronic data capture (EDC) systems, including ePRO (electronic patient reported outcomes) and eCOA (electronic clinical outcome assessment). These platforms enable direct, secure and efficient data entry by patients and clinicians, reducing the risk of transcription errors and enhancing data quality.
Certified Expertise and Regulatory Compliance
A distinguishing feature of Accelagen is its insistence on certified database builders across the Data Management Team, setting a high internal benchmark for quality and reliability. This expertise is particularly valuable for start-ups and small biotechs, where Accelagen guides these clients through every step, explaining the rationale behind design decisions and ensuring that data collection is both efficient and compliant.
Regulatory compliance is a cornerstone of Accelagen’s operations. By adhering to CDASH and other internationally recognised standards, Accelagen ensures that data is collected in a manner suitable for regulatory agency submission, including the FDA and TGA. The company maintains comprehensive documentation and audit trails within its EDC systems, supporting regulatory inspection readiness at any time.
Technology Platforms and Innovation
Accelagen primarily utilises the Viedoc EDC, however the team can also develop using alternate platforms such as Medidata Rave, thereby offering sponsors flexibility based on their preferences and trial history. The company can also leverage its comprehensive CRF library and standardising database programming to accelerate database deployment and enhance consistency across studies.
Looking ahead, Accelagen is incorporating additional smart listings and analytics tools to further improve data review, quality control, and real-time reporting. These innovations enable sponsors and project managers to access actionable items in the data earlier in the trial, supporting interim analyses and timely decision-making.
Seamless, High-Quality Data Delivery
The true measure of the database design team’s success is often invisible: a well-designed database that simply works, enabling consistent, reliable data collection without disruption. This seamless experience is the result of meticulous planning, certified expertise, and ongoing collaboration between Accelagen and its clients.
By providing tailored, compliant, and innovative data management solutions, Accelagen continues to position itself as a trusted partner for clinical research in Australia, the United States, and beyond. Their expanding toolkit and personalised service model ensure they remain equipped to meet the evolving challenges of clinical trials, accelerating the development of new therapies and improving patient outcomes.