Clinical trials are the driving force behind medical progress, saving and improving countless lives. But the process is notoriously slow and complex. What if you could accelerate your clinical trials and address key operational hurdles with robust software solutions that weren’t even on the table five years ago?
Modern technologies like AI, the Internet of Medical Things (IoMT), remote monitoring, and advanced data integration are revolutionizing life sciences research. These software advances directly impact the five critical success factors for any clinical study:
- Find and recruit the right life sciences trial subjects.
- Keep participants engaged and active in trials.
- Connect and share clinical trial data with EHRs.
- Manage compliance from phase I through phase IV.
- Configure and test your most successful life sciences trial software platform.
Let’s break down how superior life sciences software turns these challenges into strategic advantages.
Address Five Success Factors with Life Sciences Trial Software
For pharmaceutical companies, biotech researchers, and medical device makers, the mechanics of conducting a successful clinical trial are fraught with complexity. Every step presents a potential bottleneck that can derail timelines and inflate costs.
Fortunately, modern life sciences software provides the tools to streamline these processes and drive better outcomes.
Recruit the Right Clinical Trial Participants
Finding the right patients is one of the biggest roadblocks in clinical trials. A pharmaceutical company developing a new drug for joint pain can’t move forward without a specific group of people who fit a precise clinical and demographic profile.
This is tougher than it sounds. In one year, patient willingness to participate in clinical trials plummeted from 89% to just 49%. The talent pool is shrinking, making efficient recruitment more critical than ever.
AI and data interoperability power the swift software sophistication to find and engage the people who fit the precise characteristics for your life sciences trials.
Life sciences trial software can interpret billions of population and individual health record data points to identify patients across health systems and geographies who fit your trial profiles.
Retain Active Clinical Trial Participants
A clinical trial’s success hinges on keeping patients engaged and collecting ample, accurate data. But participants have busy lives, and the burden of manual data entry often leads to frustration and high dropout rates.
Intelligent software solutions dramatically improve patient engagement while minimizing their time commitment. Electronic Patient-Reported Outcomes (ePRO) technologies are a prime example. Instead of using pen and paper, participants can now enter and track their activities, symptoms, and other key information through simple, user-friendly software.
When combined with wearables, remote patient monitoring (RPM), and virtual visits, ePRO software creates a powerful ecosystem that boosts both engagement and data accuracy. This keeps participants active and ensures your trial stays on track.
Connect and Share Data with EHRs
Life sciences clinical trial selection, engagement, and data capture, and compliance all involve or depend on seeing and interacting with complete, accurate patient electronic health records.
Fortunately, EHR vendors including Epic, Cerner, eClinicalWorks, AllScripts, MEDITECH, and NextGen have already embraced the FHIR interface standard that connects the health record data dots in real-time across multiple life sciences software systems.
Manage and Document Clinical Trial Compliance
The regulatory landscape for clinical trials is complex. Your software must be built from the ground up to ensure compliance with stringent requirements.
For example, FDA 21 CFR Part 11 establishes that electronic records and signatures are equivalent to paper ones. Your software must guarantee these digital interactions are authentic, secure, and provable. This is crucial for processes like informed consent, where patients must provide written agreement after being informed of all risks. Capturing this digitally makes the process faster and easier for everyone.
Life sciences clinical trial software also must comply with:
- FDA Good Clinical Practices (GCP): A collection of regulations governing the conduct of clinical trials and the protection of human subjects.
- HIPAA Privacy and Security Rules: Standards for protecting personal health information in all its forms, especially electronic data.
- General Data Protection Regulation (GDPR): The EU’s strict data protection rules that apply to all industries handling the data of European residents.
Configure and Test Your Clinical Trial Platform
A successful clinical trial demands a sophisticated, integrated, and reliable software platform. This requires the configuration and testing of many moving parts. From EHR integration and data capture to compliance and patient engagement, every component must work flawlessly together.
The margin for error is razor-thin. Every integration, interface, remote device, and electronic signature must be precise and secure. This is why rigorous testing and QA are non-negotiable.
Your testing strategy must:
- Identify and eliminate bottlenecks in software performance.
- Stress-test the platform to determine its performance under extreme loads.
- Validate every integration to ensure data flows correctly.
Building such a platform requires a partner with deep expertise in healthcare technology.
Planning ahead for test automation in healthtech? Our experts at KMS Technology break down how to build a long-term strategy for tech leaders in this comprehensive ebook.
Build Your Clinical Software Platform with KMS Technology
Accelerate your life sciences clinical trials with a trusted healthcare software partner for platform configuration, testing, and compliance. KMS Technology is ready to support your clinical trial strategy. We offer technology development, QA and testing, and consulting services to help build, refine, and perfect your clinical trial software platforms.
Partner with KMS Technology to develop, test, and unify your systems and data sources.
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