Following the successful implementation of ClinSpark® at the Phase I unit of a top-10 biopharmaceutical company in Europe, the first study database was locked where the entire trial was conducted within the system. FDA submission-ready eCRFs of all subjects were generated in seconds and SAS data-sets from ClinSpark® are now being used to generate tables, figures and listings for the final report.

ClinSpark® is the eSource platform for Phase I trial automation from Foundry Health and was chosen to replace the legacy solution. For several months now, all new studies that start at the Phase I unit are being run in ClinSpark®. This makes ClinSpark® an integral part of an ambitious innovation agenda in early clinical development.

For a Phase I unit that is focused on first medical st-in-man studies and early clinical development, real-time access to high quality data is crucial for theaff to ensure the safety of volunteers during the study. These trials are typically complex, highly scientific in nature, always under tight deadlines and change is the only constant. ClinSpark®, an eSource system specific to the needs of a Phase I environment and early phase trials, is ideally suited to fulfill this need.

ClinSpark® is a modern, sophisticated product designed to be infinitely scalable by harnessing the power of the Cloud while being built for device and systems connectivity all while having a mobile-first computing approach. Many existing solutions are hindered by old technology, poor performance, lack of flexibility and an overall poor user experience. When the Phase I staff of this company was looking for a new solution, they realized the potential of ClinSpark®. Over the last year and a half, teams from both sides have worked closely together to ensure that ClinSpark® would meet the requirements. With version 1.4 of ClinSpark® released at the beginning of this year, that goal was achieved.

Brock Heinz, CEO of Foundry Health stated: "It was a real pleasure working with their very professional team. And while the challenges of product quality, software validation and the breadth of required functionality of one of the largest pharmaceutical companies in the world are significant, we are very happy and also proud that we've been able to meet, and at points exceed, the needs and expectations."

When the collaboration started, the list of functional gaps was not insignificant and demanded sustained effort from the Foundry Health engineers. The agile development methodology used to develop ClinSpark® typically starts with the question: "Don't tell us what you want, tell us what problem you need us to solve." From that starting point, Foundry Health engineers develop working prototypes rapidly and within several iterations back and forth with the client, new functionality is released that meets and often exceeds expectations. Using this approach, Foundry Health has made significant improvements throughout ClinSpark®, including subject recruitment and subject eligibility, the ECG review process and sample tracking and processing.

For example, based on real-life examples of complex biomarker assessments, the sample tracking features now supports the most complex of processing methods available. The application approaches electronic-lab-notebook-like functionality, available right from within ClinSpark®. This greatly enhances the capabilities of using complex biomarkers in early clinical trials. 

Brock Heinz stated: "At the end of the day, it is the user that determines success. We are so pleased to see so much positive feedback and enthusiasm coming back from this client, who now uses ClinSpark® on a daily basis."

Based on this success, the collaboration continues and keeps expanding. New developments are underway leveraging the unique connectivity abilities of ClinSpark® to efficiently enhance data collection during early clinical development to save on time and resources during later stage development.

About Foundry Health

Foundry Health is the company behind ClinSpark®, the modern cloud-based eSource platform for Phase I automation. Its modern infrastructure allows for easy connection to clinical devices, labs, databases and data review tools of all sorts. The CDISC ODM certified data structures ensure compliance with all regulatory and data standards. The modern 'mobile-first' user interface and fast bar-code enhanced navigation, make the system easy to use and contribute to the highest user experience ratings in the industry. ClinSpark® is offered as a SaaS (Software as a Service) solution with no long-term commitments, and a competitive 'pay-per-use' pricing structure. Being hosted on one of the world's most advanced cloud-infrastructures, ClinSpark® allows for almost infinite global scaling, without performance degradation.