http://datadriven.jp/

DataDriven: Simplifying the Implementation of CDISC Standards

CIO VendorIppei Akiya, Founder & CEO
The healthcare industry is a highly regulated space and players in the segment are required to comply with a variety of stringent standards. To facilitate the same, healthcare providers need to implement effective quality and compliance programs which provide for document control, compliance training, and ongoing auditing. Clinical Data Interchange Standards Consortium (CDISC) is one such globally accepted compliance standard. It’s a regulatory body that supports healthcare organizations in acquisition, exchange, submission and archival of clinical research data in digital formats. By developing platform-independent data standards, it helps both healthcare organizations and medical researchers benefit from information system interoperability. Moreover, with pharmaceutical regulatory agencies such as FDA (U.S.) and PMDA (Japan) have been made the data submission with CDISC standards mandatory for all new drug application and for other medical data, there is no escape for healthcare organizations, but to conform their data in accordance with the CDISC specified Study Data Tabulation Model (SDTM), Analysis Data Model(ADaM), and Define-XML standards.

Given the industry wide push towards CDISC, there arises a need among healthcare organizations for software and consultancy services to stay aligned with ever changing regulatory norms. Visualizing this need, Ippei Akiya, an industry veteran incorporated DataDriven in 2015. The company provides consulting and software development services related to clinical data, specifically those based on CDISC standards. Besides, the company provides maintenance services in accordance with CDISC stipulations. Ippei Akiya, Founder & CEO, DataDriven, adds, “CDISC standards are highly stringent, and therefore, it’s usually very difficult for healthcare organizations to adhere their clinical data to CDISC standards.

DataDriven adapts a long term approach to automating customer’s processes


We make sure compliance issues involved with clinical data are taken care of as dictated by the regulatory body.” Understandably, a complete implementation of CDISC standard demands huge investments in terms of capital and time, and often impacts clinical drug development, resulting in delays in delivery of a new drug to the market. In such cases, DataDriven’s advanced software solutions are helpful in optimizing time and cost and yet abide by the standards.

DataDriven adapts a long term approach to automating customer’s processes. It starts with an in-depth study of existing protocols and documentation. It then implements clinical standard, prepares documents relating to clinical protocol and designs the test items. Next, it transfers the specifications to the computer system and automates the data table and analytics. Additionally, it provides support operation process inside the client’s organization, and offers job training related to CDISC standards of pharmaceutical industry through its consulting services. To ensure adher-ence to specifications, DataDriven prepares documentation such as SOP (Standard Operation Procedure), and data specification template.

By using Artificial Intelligence, including natural language processing and deep learning technologies, DataDriven is determined to improve its software capabilities and deliver more out of client's own clinical data. The company is now developing an application software which will utilize a knowledge based Artificial Intelligence, natural language processing, semantic technology, and big data analytics to bring advanced solutions to healthcare compliance market. To this Ippei adds, “Our application software will realize a fully automated to semi-automated clinical data implementation, and reduce the cost and time involved in implementing compliance solutions.”

Based in Tokyo, Japan, the company primarily serves SME’s and major firms to major firms in the pharmaceutical industry, academic research institutes, and contract research organizations. DataDriven is now working towards expanding its business territory and distribute application software and services to U.S, Europe, and other corners of the world as well.

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