Clinical Trial Software
and Technology
Simplify all the complex parts of clinical trials for life sciences.
Every life sciences contributor has a huge stake in making clinical trials safe, swift, accurate, and secure. That includes pharmaceutical companies, biotechnology researchers, medical device makers, CROs, SMOs, and clinical trial software companies.
But process and regulatory bottlenecks can complicate every phase of clinical trials for life sciences.
Be the hero who breaks apart clinical trial bottlenecks. Partner with the smart, flexible healthcare technology masters at KMS Healthcare.
21 CFR 11 Compliance for Clinical Trial Technology
21 CFR Part 11 says that companies must treat electronic records and signatures the same as paper records and handwritten signatures. That means clinical trial software must ensure that electronic records and signatures covered by this FDA rule are authentic and provable.
To comply you must be able to show that any electronic system will:
Satisfy FDA rules for accurate, reliable, and consistent records of signatures
Recognize invalid or compromised records
Keep all audit trail documentation
Generate accurate and complete copies of records for FDA review
Protect records for accurate and ready retrieval
Rigorously check the date & time of entries that change electronic records in your software
You need confident, coordinated clinical trials for your life sciences organization or clients. Life sciences looks to technology and software partners that can help with clinical trials in three broad areas:
Expert Guidance & Strategy
Establish what you need to achieve in clinical trials and create a winning technology blueprint to get there.​
Testing & QA
Find and eliminate choke points with testing and QA for clinical trial software performance (how’s it working), load (how much traffic can it handle), and stress (how does it perform under extreme loads).
Software Development & Maintenance​
Build the software and automate maintenance to run smooth, accurate, fast clinical trials.
- Pilot and fesability studies
- Prevention, screening, and treatment trials
- Multi-arm, multi-stage (MAMS) trials
- Cohort, case control, and cross-sectional studies
Consistently Successful Clinical Trials with KMS
Make Data Sharing a Cornerstone of Your Clinical Trial Success
Better data integration among healthcare software and information systems makes clinical trials more valuable and accurate. KMS Healthcare makes it happen with advanced interoperability technology and skills:
Technology to Invigorate and Enhance Every Part of Your Clinical Trials
- Simplify complex processes for conducting life sciences clinical trials.
- Capture and manage patient, clinician, EMR/EHR, and device data on one software platform.
- Manage collaborative research across multiple clinical trials and sites.
- Comply with 21 CFR Part 11, GCP, GDPR and HIPAA.
- Recruit trial participants more effectively and simplify sign up forms and workflows.
- Randomize and categorize trial participants.​
- Improve clinical trial patient satisfaction.
- Eliminate paper from clinical trial management.
- Simplify clinical trial billing and cost management with smart, efficient payment systems.
- Design and deploy compliant studies in just days.
- Enable remote patient monitoring (RPM) and electronic patient reported outcomes (ePRo).
Data Security and Compliance for Life Sciences Clinical Trials
Insist that your clinical trial technology provider knows U.S. healthcare IT regulations outlined by:
Connect Trial Software with Healthcare Data Systems
Bioresearch organizations, pharmaceutical providers, CROs, and research sites must capture and exchange healthcare data to manage effective clinical trials.
The FHIR interoperability standard for healthcare lets software and systems talk and share data to make clinical trials more patient-focused with data that’s more meaningful and helpful.
Maintain and Support Your Clinical Trial Systems
KMS Healthcare assures that life sciences companies and technology providers can rely on and support their clinical trial management and automation software:
- Build in clear, descriptive messaging during development so your support teams can quickly troubleshoot problems and resolve errors
- Loop in your service analysts during development so they can review code and better understand how to address potential failure points
- Create a searchable error log for fast troubleshooting.
Embrace the most advanced technology development, QA and testing, and consulting for your clinical trial software platforms with KMS Healthcare.Â
Clinical Trial Innovation Snapshot
KMS Healthcare
by the Numbers
Claim Control of Consistently Successful Clinical Trials
Learn more today about how KMS Healthcare will partner with you for testing and developing software that ensures success for you and your life sciences clients.