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Digital data flow and technological solution providers

Prasoon Sangwan

Business Consultant, Business & Transformation Group

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HIGHLIGHTS

  • The Digital Data Flow (DDF) initiative envisions to digitize and automate clinical information flow across multiple clinical systems involved in clinical development life cycle.
  • DDF consists of interconnected upstream and downstream systems, linked through SDR, which adheres to data and technology standards. The essential components employed within DDF are:

  1. Source/Upstream system

  2. Study Definition Repository 

  3. Downstream systems
  • The development principle underlying DDF is to enhance the interoperability and efficiency of clinical trials through the establishment of a universal data exchange framework. By embracing DDF standards, clinical trial data can be seamlessly shared and reused across various studies and organizations, leading to time and cost savings.

Digital Data Flow (DDF) and technological solution providers

The Digital Data Flow initiative aims to streamline the processing of study protocol through automation. This paper presents how the concepts of DDF initiative along with CDISC (Clinical Data Interchange Standards Consortium) standards can be leveraged to design a technical solution to automate multiple processes of clinical development lifecycle. It explores how technology providers can collaborate in a vendor-agnostic approach, using the DDF Reference Architecture (RA) to develop innovative platforms and solutions. 

With these solutions, pharmaceutical companies can transform their manual and traditional study execution processes, leading to reduced costs, shorter study durations, and enhanced operational efficiency. Additionally, this paper details out how pharma companies can harness the power of technology to maximize the benefits offered by DDF.

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About the author

Prasoon Sangwan
Prasoon Sangwan works as a Business consultant for the TCS ADD™ Life Sciences Platform. She has more than 16 years of experience and leads major clinical transformation programs, including risk-based dynamic monitoring, central lab modernization, MDR implementation, SDTM automation, and protocol digitization initiatives. Prasoon has authored a book on SAS Grid and published multiple papers in the clinical and SAS space. She also holds a patent on high-performance computing environment.
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