Professional Links to Friends of Computer System Validation
DatStat offers a validated EDC/CDMS that’s perfect for sponsors, CROs, and investigators seeking real-time interactions with their patients, research participants, and providers. Our platform includes best-in-class eCRFs, multi-site and multilingual support, remote (offline) data capture, cross-form validations, and nested eCRFs. Ideal for PROs and post-market surveillance surveys. DatStat clients get exceptional data quality, unmatched functionality, DIY forms, and expert support at an affordable cost, so they can deliver improved health outcomes around the world. Based in Seattle, WA since 1997.
DocXellent (formerly Mystic Management Systems) has been providing reliable trusted solutions to companies from the Fortune 500 to small businesses since 1983. DocXellent provides affordable, easy-to-use, web-based, off-the-shelf total Quality Management Solution for Document Control Systems (DCS), Packaging/Specification Management, Corrective Action & Preventative Action (CAPA), and Employee Training needs.
Icon Systems Consulting
Icon Systems has worked with companies to select, install, and support ERP packages since 1995. They are independent of any software vendor and work with their clients to find the best ERP package for their needs.
Increase Your Productivity
This 21 CRF Part 11 compliant product captures handwriting on paper documents, including secure signatures, and provides searchable PDFs, clean data and secure images. Ideal for document approval, clinical trials, and form-based data capture. This is the fastest way to electronically publish an approved paper documents, and is compatible with all document/clinical management systems. It is easily deployed, with minimal training, and users like it.
Leland Hirschman is a graphic designer, web developer, artist, musician, entertainer, and so much more! His motto, "Creativity for Hire," tells you instantly that his services know no limits! If you need a creative solution to nearly any problem you have, Leland will surely have the answer. He is responsible for this website's development, as well as all of our design and development needs.
Matrix - Systems & Solutions
Since 1993, Matrix has been implementing highly controlled printing and serialization solutions in a wide variety of packaging line environments. Our 21CFR Part 11 compliant systems ensure a secure, auditable, and accountable packaging line backed by track-and-trace to the individual unit level. Matrix has worked with companies ranging in size from single-factory operations to Fortune 500 corporations and can accommodate the unique needs of any business.
QST Consultations, Ltd., founded in 1974, is an independent statistical consulting firm that specializes in clinical study and case report form design, data management, biostatistical analysis, medical writing, and complete management of eCTD submissions. The company’s involvement includes many successful phase 1-3 and post-marketing clinical studies designed to support 510(k), PMA, ANDA, and NDA submissions, along with ongoing marketing activities. QST currently works with a range of clients that extend from small start-up organizations to well-established leaders in the pharmaceutical and medical device industries.
We employ a repeatable, controlled, disciplined Quality Assurance methodology to design, build and validate software. We are a healthy company with a successful track record - fourteen years, six hundred projects, and satisfied customers in 14 countries. SageKey focuses on developing and maintaining defect free software, and providing outstanding customer service and support.