The COVID-19 pandemic brought a new sense of appreciation for clinical trials as masses watched clinical trials closely while pharmaceutical companies raced against the clock to find viable vaccines and drugs for the Coronavirus outbreak with accuracy and unprecedented speed.
But we also got a glimpse of how challenging clinical trial management can be for companies. This challenge brought a renewed sense of appreciation for human-centric software that streamlines the clinical trial process.
For biopharmaceutical and medical device sponsors, CROs, or sites, adopting a software-as-a-service (SaaS) also comes with the benefit of flexible pricing. For example, systems like Jeeva offer a modular trial-fit subscription model with pay-per-module-user pricing. This means the trial’s capital expense can be managed as a predictable operating expense.
The clinical trial software market has grown as decentralized clinical trial management systems prove their worth as a silver lining of the pandemic. But how does SaaS accelerate clinical trials and make them more efficient?
1. Forms and Process Management
Firstly, a clinical trial management system assists users to manage the paperwork and documentation necessary to get through the clinical trialing process. 35% of patients who dropped out of a study found the Informed Consent Form hard to understand, making it difficult to push through.
With the help of the right systems, patients get a better understanding of the whole process and trial administrators and concerned bodies can get feedback from prospective patients faster if there’s ever any part of the process that needs more clarity.
With integrated process management systems, clinical trials run smoothly and have a better road map for patients and administrators alike to ensure that the study runs through all operational stages with little friction.
2. Patient Management
Patient recruitment is a major issue for sponsors during clinical testing of interventions. First, finding volunteers willing to take time out to contribute to research and development is a challenge. And then there’s creating a log of all their information, experiences, and results without allowing data to fall through the cracks.
Using a clinical trial management system, companies and test administering committees can better track patient data and get a future database of possible candidates for more trials. Patient management systems help avoid losing patient data, duplicating tests on one person, getting lost with controls and placebos, and other directory and test data management issues.
Additionally, implementing a modular BYOD (bring your own device) solution like Jeeva makes it accessible to users on any browser-enabled mobile device, accelerating patient enrollment and engagement. It also provides bidirectional communication between staff and patients through email, SMS, audio, and video calls. Offering remote eConsent also reduces friction as participants get thorough patient education and fully informed consent. This eliminates confusion and complexities from lengthy paper works.
3. Data Management and Analysis
Medical data — like most data— became a new hot commodity in the healthcare industry. That’s why trends like medical coding training and big data in healthcare are on the rise. It’s hard to belittle the importance of data collection and management, especially in clinical trials where the data shows the results.
Many of today’s most common data management pitfalls have to do with trusting storing, collecting, and crunching data to a group of people who do things manually. Just as the computer took out the need to manually calculate trajectories and launch scenarios for NASA, data management and analysis tools can help speed up the data management process in clinical trials and give a more accurate result. Companies also provide all necessary clinical trial management system training to help study coordinators to automate many processes and help them save time and effort on administrative data-related tasks.
4. Data Security
Along the lines of the data conversation, data security is also crucial. Fraud, identity theft, and phishing are only some cybercrime that virtually didn’t exist two decades ago. As healthcare and pharma companies now shift towards using cloud software to empower clinical trials, data management systems help secure all patient data to avoid any leaks or hacks.
Clinical trial management software often comes with adequate layers of encryption and authentication to ensure that only authorized personnel can access data related to patients, their health, and the clinical trials themselves to ensure complete confidentiality where it’s absolutely needed.
5. Compliance Monitoring
A great number of deadweight costs go into non-compliance with government and approving boards. Fees for non-compliance can go up to at least $12,000 a day, resulting in significant wasted resources on hiccups that you can improve by using a tool that offers compliance monitoring. Thankfully, clinical trial database systems mostly come with compliance monitoring capabilities that help administrators and researchers keep track of compliance requirements and their progress.
By automating compliance monitoring, research teams, CROs, partners, and the federal bodies involved— such as the FDA— receive regular updates on test progress and provide a centralized hub for all findings, publications, and other necessities to do tests the right way.
Automation in Healthcare
The pandemic-driven rise of the e-clinical solutions software market indicates that digitization will continue to push for more automation in healthcare and life sciences accelerating clinical operations to high gear. We’re in a golden era of health and wellness as technology helps medical practitioners, scientific professionals, and boards develop better solutions to impact public health, safety, and access to make the world a better place to live.