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:
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:
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
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.