As you know, an EDC in clinical trials is a system for collecting, maintaining, and processing site-, patient-, and lab-reported data in an electronic format for use in clinical trials. Octalsoft’s EDC substitutes the old, paper-based data-collecting technique by simplifying and centralizing data collection, resulting in significantly improved drug development timeframes and costs.
To guarantee accuracy, EDC systems evaluate data entered by clinical trial locations. The data may then be reviewed and queried by data managers and clinical research associates (CRAs), with queries immediately marked to the sites. Finally, an EDC system provides a consolidated and safe location for verified, locked data that is available for analysis at the end of a clinical study.
Paper-based data collection procedures are being used in fewer trials, and this trend is projected to continue. Between 2019 and 2020, 81% of Phase I clinical studies used an EDC system. By the end of 2024, 90% of Phase I clinical trials will have used exclusively EDC applications. However not all all EDC systems are made equal. Read on as we discuss why Octalsoft’s EDC system is by far the best electronic data capture system in 2024.
Benefits of Using Octalsoft’s EDC
1. Secure Clinical Trial Data and Control
Gathering and maintaining clinical trial data in Ocatlsoft’s cloud-based data capture electronic system enables safe access and management from anywhere. When data was collected manually and on paper, it was vulnerable to loss and destruction since there were no backup or recovery solutions.
2. EDC Validation and Quality
Standard built-in checks are present in Octalsoft’s EDC. Examples include fundamental checks such as dates being recorded correctly or whether a patient's age is within the permissible range for the research, as well as more advanced checks such as if a patient is female, a pregnancy test may be required prior to participation in the study.
Octalsoft’s EDC system also conducts automatic data quality checks, highlighting any mistakes or data abnormalities. Earlie these checks were conducted manually and were thus prone to human mistakes. Octalsoft’s EDC system’s automatic inspections can save sponsors and CROs a significant amount of time, which is critical during early-stage studies.
3. Traceability
Traceability of any modifications to data or research design is also essential. With Octalsoft’s EDC system working for you, you can rest assured that all your audit trails will be stored automatically and will be conveniently accessible, thus massively reducing data outages and enhancing traceability.
4. Accessibility and Availability
Octalsoft;’s EDC system enables quicker and broader data access. As soon as data is loaded into the system, all authorized users have access; a PI can sign off on the data, a CRA can evaluate it remotely without coming to the site, a data manager can approve the data, and the sponsor or CRO may watch the study's progress.
During the COVID-19 epidemic, the advantages of Octalsoft’s EDC system were especially visible as a part of the groundbreaking team of Bharat Biotech, CyteSpace Research, and the unstoppable IQVIA brigade that steered one of India's most extensive clinical trials. Because of electronic and remote data recording, as well as the possibility for PIs and CRAs to remotely examine and monitor data, Octalsoft’s EDC proved to be a game-changer.
Octalsoft’s EDC System Benefits for Phase I Clinical Trials
Given limited budgets and deadlines for early-stage studies, deploying Octalsoft’s EDC system from the outset is highly useful. Study teams can obtain preliminary findings as soon as feasible. This is significant because early-stage clinical trials frequently undergo adjustments and pivots (e.g., in dosing levels).
Furthermore, using Octalsoft’s EDC system during Phase I clinical trials enables the use and integration of other technologies such as eConsent (electronic consent) and RTSM (randomization and trial supply management) to assist in accelerating timelines. The pandemic clearly proved the significance and relevance of OPctalsoft’s eClinical suite.
While proving hyper-effective in large-scale trials, Octalsoft’s EDC also enables small to mid-sized CROs performing Phase I clinical trials to differentiate themselves from the competition by conducting efficient and high-quality studies and fast scaling and progressing into Phase II and Phase III trials.
How Can Octalsoft’s EDC System Support Early-phase Clinical Trials?
Octalsoft’s EDC has a significant influence in these early-stage experiments. Using it allows streamlined data capture, pushing effective medications to advance quickly into the next phase, giving research a leg up on the competition.
Rather than manually or disparately monitoring a small group of healthy volunteers using paper or an Excel spreadsheet, Octalsoft’s EDC lets investigators focus on the patients rather than data management. This is critical because patients require close monitoring at this point. Despite the fact that these trials involve a smaller number of participants, the amount of data acquired on each individual is significant.
Data quality is further improved by Octalsoft’s EDC systems' automated validation tests and query procedures.
Additionally, if any adjustments, such as dose amounts, are required, our EDC guarantees an audit trail, verifiable mid-study alterations, and continuous data collecting.
While low-tech procedures may have worked in the past for early-stage studies, they become considerably more difficult as complexity increases and the requirement for clinical trial technology becomes critical.
As a result, sponsors and CROs must collaborate with reliable technology suppliers that have extensive experience and a track record of performing early-stage studies.
Octalsoft's EDC enables easy and automated collaboration between various stakeholders, with worldwide connectivity, real-time recruitment progress tracking, and subject statuses on the EDC dashboard, hierarchical workflows for data entry, verification, and validation, real-time automated edit checks, insights into data queries and resolution on a very user-friendly interface.
