Sofia, May 11, 2022 –Sqilline has transformed into a Clinical Research Organization (CRO). The company is set to further develop its innovative digital approach in clinical trials and observational studies. This strategic approach is the result of five years dedicated work in the field of real-world data (RWD) and real-world evidence (RWE).
“Since its launch in 2018, Danny Platform has been developed as a real-world data analytics platform”, said Desislava Mihaylova, General Manager of Sqilline. “Our software processes electronic health records sourced from over 45 leading hospitals in Bulgaria. We apply key solutions for data structuring and normalizing. Our customers receive valuable data reports and insights in various diseases areas. Sqilline has executed multiple real-world data projects with several international medical publications well-perceived by the scientific community. Our focus now is to further develop and expand in clinical research and observational studies.”
Real-world data (RWD) and real-world evidence (RWE) are already used in the regulation of the development, authorization, and supervision of medicines in the European Union. Their place in safety monitoring and disease epidemiology are well-established while their evidentiary value for additional use cases, notably for demonstrating efficacy, requires further evaluation. There is already a widespread use of RWE to support evaluation of new marketing authorization applications (MAAs) and extensions of indication (EOIs) for already authorized products submitted to the EMA in 2018 and 2019.
Sqilline has developed digital technology and established methods and standards for high-quality collection and use of RWE, in cooperation with stakeholders including patients, healthcare professionals, industry, regulatory and public health agencies, health technology assessment bodies, payers, and academia.
Sqilline shares the vision that RWE and randomized clinical trials (RCTs) should be seen as complementary, each having strengths and weaknesses, with their relative importance depending on the scientific or regulatory question.
Sqilline offers management of observational studies from feasibility and patient recruitment to data management and filing documents to the authorities. The process is fully supported by Danny Platform evaluating massive amounts of RWD from multiple clinical sources and providing RWE. Danny Platform is a digital health product powered by SAP Hana Database – a leading big data platform and incorporates machine learning (ML) and artificial intelligence (AI). The whole service has the potential to reduce cost, increase speed, and ease the burden on all participants.
Sqilline offers a complete end-to-end solution for sponsors and investigators aiming to enhance clinical research. Company’s transformation into a Clinical Research Organization (CRO) is driven by the key stakeholders’ needs, real-world data and evidence, and the digital technology.
Sqilline is transforming human health through technology. We speed up R&D in medicine and improves patient access with its Danny Platform and Life Science Services. Moving from a pure healthtech company to a clinical research organization (CRO) driven by digital technology is part of the transformation journey.
Read more at Danny eClinical Research Solutions