What’s New

See what’s happening at Simplified Clinical.  Whether it’s new functionality in our Clinical Discovery Platform, new partnerships, or successful applications of our technologies, you’ll find it here.

July 23, 2019 – Simplified Clinical Data Systems, LLC today announced the establishment of new EU data processing center.

In response to increased demand from clients based in the UK/EU, Simplified has leveraged the global footprint of the Microsoft Azure cloud computing environment to expand its international reach.  “We couldn’t be more excited to see our plans for international expansion come to fruition”, says John Schwope, company founder and President/CEO.  The establishment of this UK/EU based processing center allows Simplified Clinical to meet every regulatory requirement facing clients in the region, as well as improve their end user experience by increasing the speed and responsiveness of its Clinical Discovery Platform (CDP).

As a result, Simplified has recently signed a Master Services Agreement to provide it’s products and services for all clinical studies performed by an industry leading UK based diagnostics company.  “Our ability to deploy our CDP [locally] to this new client was a key factor in being awarded this contract”, said Mr. Schwope.  “Within 3 months of signing this agreement, we have already put 2 new studies into production for them”.

July 16, 2018 – Simplified Clinical Data Systems, LLC today announced the completion of transitioning their computing infrastructure to Microsoft’s Azure cloud computing environment

After nearly a year of evaluation, testing, and working with Microsoft, Simplified Clinical has moved its Clinical Discovery Platform (CDP), as well as all internal DevOps, and administrative computing environments to Azure.  This move represents a major step forward for the company, giving them global reach, limitless scalability, and the most advanced, regulatory compliant Infrastructure as a Service (IaaS) available today.  “Our current and potential clients need to conduct clinical trials all over the world, and demand a solution provider who can support them in that effort”, says John Schwope, company founder and President/CEO.  “Microsoft Azure gives us the ability to deliver our Clinical Discovery Platform (CDP) in 54 regions around the world (currently), in compliance with specific, local, national/international regulations. Read more…

October 20, 2017 – Simplified Clinical Data Systems, LLC is pleased to announce the latest release of its Clinical Discovery Platform (CDP)

In addition to several system enhancements and bug fixes, CDP now provides our clients with advanced tools to support and facilitate Risk-based Monitoring efforts.  This new data analytics suite allows for the creation of custom-tailored reports and operational triggers to help clients perform and manage study-specific field monitoring plans. Using CDP, our clients have the capability to assess quality metrics (e.g., missing data, data error rates, protocol violations) in real-time to help identify potentially higher risk sites for the purpose of targeting sites in need of more intensive monitoring.

Available immediately and at no additional cost, CDP now provides our clients limitless possibilities for taking advantage of the significant operational efficiencies that come from the implementation of Risk-based monitoring (FDA Guidance – Risk-based Monitoring).

Clients can define triggers within CDP to alert, support, and drive Risk-based Monitoring Plans.  Whether they are driven by statistical algorithms, predefined sampling rates, site performance metrics, or specific endpoint values/variances, our integrated tool set allows you unlimited configuration options.

August 5, 2017 – Simplified Clinical Data Systems, LLC announces New Adverse Event Reporting Module for Medical Device Companies

The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation specified that reports be filed on FDA Medwatch Form 3500A or an electronic equivalent. The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. This rule will be effective as of Aug.14, 2015.In response, SCDS has created a new eMDR reporting module for its Clinical Discovery Platform. This new module will utilize the FDA’s Electronic Submissions Gateway (ESG), an agency-wide entry point for all electronic submissions, including eMDRs.

March 31, 2017 – Simplified Clinical Data Systems, LLC announces the completion of an enterprise-wide Master Services Agreement with one of world’s top 25 Medical Device Manufacturers

As a result of a 9 month evaluation/qualification process, SCDS has been selected to provide an enterprise-wide solution for eClinical software and related data management and biostatistics services.  The evaluation process was based on meeting stringent qualification of regulatory, quality, and overall business requirements.  “Being selected as a result of such an extensive and competitive evaluation process is most gratifying to me, and our entire team”, stated John Schwope (SCDS President).  “As always, we look forward to delivering significant net value, and developing another long-term relationship with an internationally recognized leader in the medical device industry”.

December 3, 2016 – Simplified Clinical Data Systems, LLC announces new portal for automated collection of medical device data

This new, universally accessible data portal allows our clients to seamlessly collect and incorporate data into the Clinical Discovery Platform directly from the medical device, itself.  This functionality improves the speed and quality of combined device and eCRF data in one data repository.  As a result, data analysis and reporting is simplified significantly, allowing clients to generate meaningful information in a fraction of the time and cost of traditional data “silos”.

April 22, 2015 – Simplified Clinical today announces the appointment of Christine Tjossem, Vice President of Biostatistics and Data Management Services.

Christine Tjossem joins Simplified Clinical Data Systems as Vice President of Biostatistics and Data Management Services. She assumes this role with an enviable 30 year track record of successful growth and leadership. Her past experience includes key roles establishing and managing biostatistical, and data management efforts at some of the world’s leading clinical research and medical device organizations.

As Vice President of Biostatics and Data Management, Christine is responsible for all facets of her team’s success in advising and implementing appropriate techniques and methods for statistical and data management areas (Details Link – New page). In addition to managing these line-of-business functions, Christine’s vast breadth and depth of experience, allows her to make significant contributions to the company’s new product and business development efforts.

Even prior to joining Simplified Clinical, Christine has been an avid practitioner and thought leader in the use of Simplified’s Clinical Discovery Platform (CDP). Her sustained, invaluable input and support, is reflected in current offerings, and has been a major factor in the company’s long-term success.

Christine received her Bachelors of Science degree in Statistics from Iowa State University.

March, 25, 2015 – Simplified Clinical today announces the promotion of Brianna Lalmond to Director of Client Services.

“Brianna has been a dedicated professional to both her colleagues and her clients,” said Eddy Tabit, Vice President of Operations at Simplified Clinical Data Systems.”She literally wrote the book on our Clinical Discovery Platform (CDP), having authored user and administrator instructional manuals for clients, and audit ready internal processes.”

In her role as Director of Client Services, Brianna is responsible for assuring absolute client satisfaction which includes mission critical data/quality assurance, project management and end-user training and support. On a day-to-day basis she conducts end user training, manages client-focused timelines, oversees quality assurance efforts, and the Clinical Discovery Platform (CDP) system documentation. Brianna’s professional development goals include involvement in the company’s sales and marketing efforts.

Brianna started her career with Simplified Clinical in 2009 and was quickly promoted to Senior Quality Analyst based on ability to learn quickly, and adjust to the rapidly changing environment of a software startup. Her competence and strict attention to detail positioned her well for successfully performing data and quality assurance functions, and for assuming greater front-line responsibility.

While not at work Brianna enjoys physical fitness training, volunteering with children, and her dog, Stella.

February 13, 2015 – Simplified Clinical Data Systems is pleased to announce a special release of its market-leading Clinical Discovery Platform.

This release includes a significant upgrade to the electronic Case Report Form (eCRF) designer making it even more user friendly, as well as providing enhanced “Adaptive Form” functionality.

The ease of use enhancements further support our client’s desire to DIY their eCRFs. While many clients prefer to use Simplified’s eCRF design and validation services, larger research groups or those looking to reduce costs find that creating their own eCRFs, is an attractive alternative.

  • Drag and drop data field/text placement
  • Auto-align page elements
  • Limitless possibilities for style/color/layout
  • No programming skills required

In response to continuing client demand for a more intuitive, error-free end user experience, the upgraded form designer includes the ability to make eCRFs “Adaptive”. The result is eCRFs that respond to end user input. Related follow-up questions and/or form sections intelligently appear/disappear or change appearance, in response to specific user input. This functionality is unique in the market as all of this is done within the paper-form metaphor, without requiring the end user to submit or refresh the page.

The enhanced form designer is available immediately to all qualified system users, at no additional cost.

October 15, 2014 – Simplified Clinical Announces the Release of Enhanced Reporting and Data Visualization Tools as Part of the Clinical Discovery Platform

In response to the ongoing needs of our clients for turning data into knowledge, Simplified Clinical has released a new, industry leading reporting and data visualization toolkit. This long-awaited upgrade to the reporting and data visualization functionality of our Clinical Discovery Platform (CDP) is available immediately and at no additional cost to all clients. The new toolkit now provides our clients with limitless possibilities for reporting on, and visualizing their clinical trial data in real time.

June 30, 2014 – Simplified Clinical Announces Strategic Partnership with Xand/TierPoint

After several months of evaluation and qualification, Simplified Clinical has finalized plans to leverage the state-of-the-art, highly available, IT infrastructure of Xand/TierPoint.  This new partnership will create a flexible IT infrastructure on which to run the Clinical Discovery Platform, and deliver an environment that is scalable, secure, & always available. In addition, it enables our clients to meet strict regulatory compliance requirements, and distinguishes Simplified as an industry leader in Service Level Agreements and business continuity. (read full article – pdf)

March 11, 2014 – Simplified Clinical Releases New SAS data file download

This quarter’s release includes the capability for clients to download native sas7bdat files.  These files can be imported directly into the [industry standard] SAS statistical analysis tool set, and are available 24/7/365 to all qualified system users.

November 12, 2013 – Simplified Clinical Releases New eCRF Review Functionality

One of the highlights of this quarter’s Clinical Discovery Platform code release is the addition of a fully customizable eCRF review module.  This new module will allow clients to add any number of eCRF review levels (Data Management, Safety, etc.) and workflows in order to meet their own predefined SOPs/Guidelines/Work Instructions.  They can even assign naming conventions to match those they already use.  This new functionality further exemplifies Simplified Clinical’s commitment to build systems that adapt to the specific needs of each client.

April 25, 2013 – Simplified Clinical Releases Enhanced Web Services for Device and Remote Monitoring Systems

Simplified Clinical is pleased to announce the release of enhanced web services as part of its Clinical Discovery Platform (CDP) to facilitate the exchange of data between medical devices and remote monitoring systems.  This new system functionality will allow a sponsor to seamlessly capture data directly from the investigational device.  This data will be stored in CDP as well as the sponsor’s remote patient monitoring systems.  In addition, the new web services functionality allows for error free data collection, with no human intervention, and sets the stage for the capture of electronic health record information from any EMR system.

January 29, 2013 – Simplified Clinical Renews Multi-Year Master Service Agreement with Diagnostics and Connected Health Management Leader

Simplified Clinical is pleased to announce a multi-year, contract extension with an industry leader in diagnostics and connected health management. The master services and enterprise-wide licensing agreement covers the use of the company’s Clinical Discovery Platform, and all associated services for clinical trials, worldwide. (read full release – pdf)

October 2, 2012 – Simplified Clinical Partners with Iron Mountain To test Business Continuity Services

Simplified Clinical is pleased to announce a partnership with industry leader Iron Mountain to pilot their SaaSProtect Continuity Services™. An industry first, this SaaS-focused contingency solution combines advanced recovery-as-a-service, source code escrow, and data restoration capabilities into one powerful, comprehensive service. (read full release – pdf)

July 23, 2012 – Multi-Year Master Service Agreement Signed With Major Medical Device Manufacturer

Simplified Clinical recently signed a five-year Master Agreement with one of the world’s largest medical device manufacturers. This agreement provides full use of its Clinical Discovery Platform and associated study design, hosting, and support services for studies, worldwide. (read full release – pdf)

January 10, 2012 – Master Services Agreement Signed for Global Clinical Trials

Simplified Clinical is thrilled to announce that a master services and enterprise-wide software licensing agreement has been recently signed with one of the world’s leaders in diagnostics and connected health management. This agreement provides unlimited use of Simplified’ s Clinical Discovery Platform for clinical trials, worldwide. (read full release – pdf)

November 17, 2011 – Eddy Tabit Promoted to Vice President

Simplified Clinical announces today that Eddy Tibit has been promoted to Vice President of Operations. In his new role, he serves as Vice President responsible for overall Quality Assurance and Operations. Mr. Tabit joined Simplified Clinical Data Systems in 2005 as Director of Quality. (read full release – pdf)