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.

A lot of things fit in those three lanes. When the right software partner can help you with all three, you’re on the path to elite performance and outcomes in all types of interventional and observational clinical trials:

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

The right software and technology strategies and collaboration make clinical trials work reliably and fast. Team with KMS Healthcare to:

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:

Embrace the most advanced technology development, QA and testing, and consulting for your clinical trial software platforms with KMS Healthcare. 

Clinical Trial Innovation Snapshot

KMS Healthcare worked with a clinical trial technology company to develop a debit card system that made expense management a breeze for clinical trial managers and participants.

KMS Healthcare
by the Numbers

platform integrations supported
0 +
patient records managed
0 M+
provider records managed
0 M+
patient visits managed
0 M+

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.