Moving Beyond Simple APIs in the eClinical Stack

True integration is critical to plug and play coexistence

SAN FRANCISCO, May 21, 2015 -- goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, announced today that the company is the only non-TMF vendor to have released a fully integrated framework based on the new DIA TMF reference model (version 3.0) XML-based exchange mechanism.

"We believe in moving beyond simple APIs, to an enterprise integration framework built as a reflection of the applications user interface", said Jae Chung, goBalto's Founder and President. "Unlike other vendors, that simply publish their APIs, goBalto provides an integration framework, which includes enterprise APIs for all relevant integration points."

"Our enterprise APIs enable other systems or transformation layers to interact with the application data in much the same way that a user would", said Dr Rob Wynden, goBalto VP of Technology and Engineering. "Meaning that out-of-the-box our APIs are actually pre-built and only need to be published. For goBalto Activate, our flagship product built on a modern SaaS architecture, these serve both the application user interface and the integration layer."

System integration is done to ensure enterprise business processes work seamlessly between all involved systems, which minimizes and optimally eliminates any human intervention in the integration, thereby improving and ensuring overall data quality and reusability throughout the enterprise.

The challenges in integration of eClinical systems stems from the lack of standardization, it's simply not enough to have APIs available. "What's required is a deep understanding of the right type of integration at the right time for the different integration points", said Wynden. "Having this industry expertise, our customers have successfully completed numerous integrations."

According to Wynden, "The life sciences industry has recognized study startup as one of the worst performing areas in clinical trials, which is why the selection of an industry proven study startup solution with a robust integration framework is critical."

goBalto's proven integration sequence of integration points:

  • CTMS – to seed Activate and get key identifiers for subsequent integrations and milestones for business process handover
  • CRM – to ensure historical reuse of data on organizations and people
  • User management – for single sign-on and training management
  • Data warehouse – to support enterprise reporting
  • eTMF – to ensure audit readiness

Key integration components (i.e., data staging, business rule compliance, target data staging, and API processing) are provided to ensure a seamless and successful integration.

To learn more about the goBalto TMF framework and how you can accelerate your clinical trials visit Booth 1241 at the DIA Annual Meeting, June 14-18 in Washington D.C., or contact us.

About goBalto

goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the pharmaceutical, biotechnology, and medical device industries. Our management team has over 100 years of combined experience in the life sciences industry and enterprise software implementation. Our team has worked for such companies as Amgen, Genentech, Quintiles, Roche, Johnson & Johnson, and Model N. With a proven commitment to customer success, disruption, and study startup optimization, we’re changing the way our leading global pharma and CRO customers approach their business processes. Based in San Francisco, California, we have satellite offices in Pennsylvania and Singapore. For more information, visit