Life Sciences Software Development for Clinical Trials

Embrace Inventive Life Sciences Software to Recruit, Retain, Comply, and Configure Successful Clinical Trials

Healthcare clinical trials save and improve lives.

What if you could ensure the expedited success of five key clinical trial components with genius software solutions that weren’t quite ready for prime time five years ago?

You can. AI, IoMT personal medical devices, remote monitoring, ePRo and eCOA, integration technologies such as FHIR and SMART on FHIR, and more life sciences software advances boost five success factors for clinical studies and life sciences research: 

  1. Find and recruit the right life sciences trial subjects.
  2. Keep participants engaged and active in trials.
  3. Connect and share clinical trial data with EHRs.
  4. Manage compliance from phase I through phase IV.
  5. Configure and test your most successful life sciences trial software platform.

Conquer Five Success Factors with Superior Life Sciences Trial Software

Medical technology concept symbolizing life sciences software development for clinical trials

The mechanics of conducting successful life sciences trials remain complicated for pharmaceutical companies, biotechnology researchers, medical device makers, CROs, SMOs, and clinical trial software companies.

Superior life sciences software technology can advance five critical elements of success for clinical trials:

Recruit the Right Clinical Trial Participants

Let’s say a pharmaceutical company has an experimental drug in development designed to alleviate a particular type of joint pain in the knees and hips. The company and its trial partner must find the right people with that ailment and clinical and demographic profile to participate in an effective clinical trial.

That’s tough to do. In 2020, patient willingness to participate in a clinical trial dropped from 89 percent to 49 percent from the previous year. 

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

Woman with face mask using smart phone while reading her medical report in waiting room at the clinic.
Female patient examining medical paperwork and using mobile phone while sitting in hallway at the hospital.

Life sciences clinical trials succeed when patients stay engaged to fulfill the trial with ample accurate data. 

But participants are busy with real life. Intelligent life sciences software solutions significantly improve patient engagement while minimizing their time burden. 

ePRO: As one example, electronic patient-reported outcomes (ePRo) technologies dramatically simplify accurate patient data collection in clinical trials. 

Life sciences clinical trial participants used to self-report with paper, pen, and phone calls, often getting frustrated and dropping out. Now they enter and track their activities, symptoms, and other information using fast and simple ePRo software. 

ePRo software works alongside wearables, remote patient monitoring (RPM), virtual visits, and other swiftly evolving life sciences software solutions that elevate clinical trial engagement and accuracy. 

Connect and Share Data with EHRs

Cartoon EHR or electronic health record concept. Doctor using digital smart device to read patients data online.

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. 

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Comply with and Document Clinical Trial Requirements

The FDA 21 CFR Part 11 rule says electronic records and signatures are equal to paper ones. Life sciences clinical trial software must ensure those electronic records and signatures are authentic and provable.

Here’s an example:

Clinical trials for new drugs or medical devices require informed consent, which is the patient’s written consent to participate after researchers have shared all relevant health and risk information. Sharing information and capturing the consent signature digitally in compliance with 21 CFR 11 makes the process faster and easier for trial investigators and participants.

Researchers also must provide complete and truthful information throughout the trial and capture patient acknowledgment. A digital platform automatically documents these communications with date and time stamps.

Life sciences clinical trial software also must facilitate compliance with:

  • FDA Good Clinical Practices (GCP), a collection of 14 regulations (including 21 CFR 11) governing human subject protection and the conduct of clinical trials.
  • The HIPAA Privacy and Security Rules that define standards for protecting personal health information in all forms, including “health information that is held or transferred in electronic form” 
  • The European Union General Data Protection Regulation (GDPR) that broadly enforces data protection rules across all industries in Europe (and sometimes outside of Europe). 

Configure and Test Your Clinical Trial Platform 

Medical technology concept symbolizing SMART on FHIR - Doctor holding ipad with medical icons around ut

Understanding other key components of successful clinical trials clarifies just how sophisticated, integrated, and reliable a life sciences trial software platform must be. Optimum clinical trials demand the configuration and integration of many moving healthcare technology parts. 

For example, here’s a critical technology component we’ve barely addressed: EHR integration. Subject selection, engagement and data capture, and compliance all involve or depend on seeing and interacting with complete and accurate patient electronic health records. 

Any trial platform must start with this foundation. Fortunately, EHR vendors including Epic, Cerner, eClinicalWorks, Allscripts, MEDITECH, and NextGen have already embraced the FHIR interface standard that all of healthcare is moving to rapidly. 

With EHR integration as a baseline, how do life sciences organizations map out configuration requirements for a robust, effective clinical trial software platform? 

Configure Your Confident, Fast, Precise, Successful Clinical Software Platform with KMS Healthcare

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You need an elite, expert healthcare software partner to accelerate simpler, faster, more successful life sciences clinical trials with confident platform configuration, testing, and compliance.

That shortlist has KMS Healthcare at the top (with some distance). 

Partner with the smart, flexible healthcare technology masters at KMS Healthcare to excel in your life sciences clinical trial strategy, software platform, results, engagement, reporting, and efficiency. Embrace the most advanced technology development, QA and testing, and consulting for your clinical trial software platforms. 

Testing and QA: Life sciences clinical trials have slim margin for error. Every integration, interface, remote connection and device, electronic signature, and audit point must be confidently precise. 

Demand clinical trial software testing and QA that: Finds and eliminates choke points in software performance (how’s it working), load (how much traffic can it handle), and stress (how does it perform under extreme loads). 

Make Your Life Sciences Trials Confident, Fast, and Precise with Technology Solutions from KMS Healthcare

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Learn more now about partnering with KMS Healthcare to develop, test, and unify every system and data source to amplify your life sciences clinical trial confidence and success. 

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