Having to delay yet another regulatory submission because of SAEs and protocol variances uncovered late in the process, the researchers at Sierra thought, "There has to be a better way. Since it's not on the market, we'll create it ourselves."

They converted their hands-on, long-term experience in FDA-regulated clinical research and database management into CRIS - the industry's first truly integrated, fully interactive, clinical research software that captures, archives and reports on real-time information across an entire clinical enterprise.

That was 14 years ago. Now in its eighth version and fully web-enabled, CRIS remains the fully integrated, Part 11-compliant clinical research software package, which is why local, national and international medical products companies have chosen CRIS for numerous clinical research studies.

And because CRIS was developed by researchers for researchers, it delivers the features Sierra knew were priorities for sponsoring companies:

• Total integration of every step of the research process into a single solution, reducing the capital expenditures and training costs associated with multiple, non-integrated modules;
  
  
• Web-enabled to integrate all of the stake holders in the clinical trials process, from investigators using EDC, clinical operations, materials management, safety or data management - even IRB's data monitoring boards or regualtors- regardless of their location.
  
  
• Easy installation and maintenance procedures with full data migration and validation support; and
  
  
• Intuitive interface and functions for quickly bringing current staff members, and an ever-changing roster of new ones, up to speed and ready for work.

Creating CRIS is half of Sierra's story. The other is how Sierra forges close working relationships with each of their customers to maximize their use of CRIS and the potential of their research programs through:

• Complete Training and Support - Validation and testing training; data migration, on-site, off-site and online user training with refresher courses upon request; product support in person, online or on the telephone - all the way to 24/7 global multi-language support if you need it.
  
  
• Sierra Medical/Regulatory Consulting (Sierra MRC) - Scientists and medical experts guiding start-ups and first time clinical trial sponsors, and supporting large corporations with stretched resources, in the planning, development, execution and analysis of their clinical trials.