Clinical trial costs keep rising, while returns on investment drop. To correct this imbalance, research teams must find ways to boost efficiencies — streamlining the work they do without sacrificing data quality or compromising on regulatory compliance measures.
To achieve this balance, clinical trial teams can seek help from digital solutions. Tools like Anju’s CTMS Master can help teams streamline clinical trial efforts with automated monitoring and reporting tools.
Costs and Efficiencies in Clinical Trials
Data management has long posed challenges for clinical trials. Gathering data, preserving it in usable formats, and moving it from paper to digital has occupied clinical trial teams’ time and efforts for years.
As late as 2021, Giacomo Cappon and fellow researchers noted that many studies used “a recurrent two-phase approach,” in which information was collected on paper and then inserted into a digital system. This method “requires clinicians to run multiple periodical visits to retrospectively analyze a large amount of information, which is clearly burdensome for the clinical facilities which host the trial,” note Cappon et al.
Monitoring data, ensuring quality, and creating reports are time-consuming tasks that slow down the progress of clinical trials and raise their costs. When elements of these tasks are automated, however, clinical trial teams are freed to focus on other work. They can also monitor data and automate site correspondence like follow-up reports to save time.
Benefits of Automated Monitoring and Reporting
Clinical trials will likely always require human involvement. Yet humans can benefit from assistance by automated monitoring and reporting solutions.
In an August 2023 article in the Asian Journal of Pharmaceutical Research and Development, Sudhakar Pachiappan and fellow researchers identify several benefits to digital monitoring during clinical trials:
- Faster completion of work.
- A higher percentage of tasks completed on time.
- Reductions in time required to produce reports.
- Improving quality and accuracy of study data by allowing clinical trial teams to focus on data collection and analysis.
Automated digital monitoring and report generation can also boost security efforts and strengthen regulatory compliance regarding trial participant privacy and security. For example, digital solutions can be used to protect records, validate source documentation and access credentials, and encrypt sensitive data during transfer.
As opportunities to generate, collect, and access digital information expand, so does the need for a robust data infrastructure to manage and analyze that information, write Cristina Durán and Matthew Bonam at AstraZeneca. These solutions must balance access needs with privacy and security concerns, as well as provide an easily navigable user interface.
A solution with built-in security and an intuitive user interface helps clinical trial teams make the most of available data — and automate necessary reports.
How CTMS Master Helps Streamline Clinical Trials With Automated Features
Automated monitoring and reporting features can eliminate the need for manual data entry, flag potential discrepancies or omissions in data, and facilitate sharing of information among clinical trial teams and healthcare providers, key opinion leaders, Medical Affairs teams, and others involved in the process of bringing a new treatment or therapy to market.
CTMS Master’s automated features include:
- Workflows. CTMS Master includes an integrated Site Visit Report tool with automated workflows — eliminating the risk of duplicate data entry and streamlining clinical trial teams’ efforts to collect necessary information.
- Report generation, authorship, and approvals. Within the integrated Site Visit Report tool, users can generate reports automatically, edit them at once, and enter an automated workflow for authoring, review, and approvals.
- Protocol deviation management. CTMS Master allows for both automated and manual deviation tracking, as well as automated resolution processes. This makes protocol deviation management easier and more accurate with automated tools.
- Report scheduling and delivery. Researchers can choose from 200 included standard reports or custom-build reports. They can generate reports for a selected project or across domains, export to PDF or Excel with built-in bookmarking, and automate report scheduling and delivery according to role and permissions — ensuring the right information reaches the right people at the right time.
The costs of clinical trials continue to rise, and they aren’t likely to decrease soon. To maintain data quality, achieve regulatory compliance goals, and secure an acceptable return on investment, clinical trial teams must streamline their work. Automated reporting and monitoring tools like those incorporated in Anju’s CTMS Master can help clinical trial teams achieve this goal.
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Authored by Laura Acosta, VP of Product Management, eClinical Division
Laura Acosta, VP of Product Management for Anju’s eClinical Division, brings over 25 years of experience in life sciences software, including significant roles at Oracle Health Sciences. With academic credentials from Boston University and Tufts University in Computer Science, Laura excels in navigating the complexities of eClinical solutions. Her commitment to continuous learning and innovation has earned her recognition as a trusted leader in the field. Connect with Laura on LinkedIn to explore her expertise further.