News

9 September 2021 News

We left Data Management




We have always stood for innovative, scientific and creative approaches to work. Indeed, we were one of the first companies in the industry to apply many innovative principles in the past which now became new industry standards, best practices.

For instance, we were the first EDC/IRT developer to implement blockchain technology for reliable audit trail storage. We were also the first provider to develop AI for automated medical coding with several dictionaries, to save our clients thousands of working hours every year. Moreover, since the FDA announced the requirement for LOINC codes submission, we immediately came up with an engineering solution to support the concept of what is supposed to be coded, when and by whom. In addition, during the first couple of weeks of the COVID-19 pandemic we developed algorithms for remote monitoring in the system. Thereby, our users were able to continue trials interrupted by the pandemic and start new trials in 2020-2021. It has become no longer necessary to visit enrolled sites. Moreover, we now offer a new hybrid Fast Track approach for large scale clinical studies, which have been successfully tested during the pandemic through dozens of projects, including one of the largest phase III vaccine trials in the world. On top of that, we were the first company in the industry to offer an ePRO solution available for all patients simultaneously through a cellphone app, desktop web page and/or compact mobile web page on numerous desktop and mobile devices.

Finally, we have not been limited to only size growth and technological progress – one of the first companies in the industry, we adopted Agile methodology in software development and data management. For example, we have implemented and validated innovative DevOps practices and CD/CI-concepts. We truly share and support principles and values of Teal organizations.

Today we join leaders of the modern e-Systems and Clinical Data Management markets to support an upgrade of conservative Data Management to a new level towards better understanding, quality and speed of data processing.

Data Science Memo

Our Mission

  • By January 1, 2023 implement new approach to data management in clinical trials conducted on MainEDC™
  • Create new methodology, approaches and functionality inside MainEDC™ to offer users most innovative practices and tools

Tasks

  • Improve quality of Clinical Data Management
  • Improve competitive advantage of our partners
  • Improve performance of DM/DS professionals
  • Improve data-processed-per-time-unit ratio
  • Improve efficiency
  • Improve speed of delivering results
  • Improve cost-effectiveness

Destinations:

  • Traditional studies
  • Virtual “siteless” / “decentralized” clinical trials
  • Trials with synthetic control arms
  • Adaptive clinical trials
  • RWE/RWD
  • Image processing

Methods and algorithms

  • AI
  • Fraud detection
  • Anomalies
  • Pattern matching
  • Trends
  • Machine learning
  • Deep learning
  • NLP (Natural Language Processing)
  • Free Text mining
  • Risk-based monitoring upgrade to Risk-based approach


Humans are more valuable than data, data is more valuable than everything else

Clinical trials exist while data can be collected and processed

Data Managers and Data Scientists are the key elements of every clinical trial