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Rutuparn Paratkar

Senior Consultant and Business Relationship Manager

The unprecedented global scenario due to COVID-19 has promptly accentuated decentralized clinical trials (DCTs) in medical research. Interestingly, public health concerns and travel restrictions helped contract research organizations (CROs) in fostering novel and transformative ideas in conducting clinical studies. The CROs are continuously looking for optimizing study time and accelerating data-driven insights through secured means. Let’s explore some of the technology strategies that could enable CROs to efficiently conduct decentralized clinical trials as well as accelerate generation of data-driven insights.

Decentralized clinical trials: A transformed way of clinical studies  

Clinical trials that involve advanced procedures, such as cell culture, bioanalytical studies, or a need for MRI, must be administered at a research site. However, in the less-complex studies, a medicine or drug can be administered at a local site. During decentralized clinical trials,  the subject (patient) receives medicine at a local site, and the patient’s body vitals are monitored and recorded using remote or wearable devices. While not all studies can be done completely virtually, a good number of studies can be conducted at hybrid and decentralized locations. A decentralized clinical trial is an unconventional method that depends primarily on the effectiveness of its technology. The CROs must focus on building a solid technology foundation. A secure and modernized technology platform providing interoperability in information exchange is necessary to maximize the potential of DCT.

Figure 1: Schematic representation of the DCT ecosystem and technology enablers

Building for future – A scalable, adaptive, and agile enterprise architecture

Connected devices, electronic data capture, and massive data crunching are the realities of CROs. Alternatively, CROs are also known as data companies. An enormous speed at which data will be generated by the connected devices needs local data storage and computing capabilities. The enterprise architecture for these organizations thus needs to be adaptive and scalable to all such future requirements and trends. Edge computing enables advanced and real-time data analytics. DCTs require organizations to work with several local labs and sites. These labs and sites can be on different kinds of IT infrastructure. Organizations need to invest in creating an agile enterprise architecture to cater to these needs. Some important considerations for technology and business architecture are listed below:

  • Revitalized Core: An end-to-end, horizontal approach is required in modernizing the core. The success of new technologies deployed for real-time data processing, advanced analytics, ML, automation, low-code, hyperconnectivity, etc. need a robust core at the backend.
  • Composable business architecture: Figure 1 depicts distributed components in the ecosystem. An API-led systems integrations capability with an event-driven and built-in security is highly desired.
  • Governance framework: In this context, the breadth and depth of IT governance naturally is wide. Numerous IoT devices spread across geographies, hyperconnected systems, and agile software development require state-of-the-art monitoring and support tools.
  • Advanced analytics: Analytics is at the crux of clinical studies. An advanced data platform with AI-enabled capabilities for data and text mining, and predictive and exploratory analytics helps deliver insightful reports in real time and shorten the overall study cycle.

‘Zero-trust’ cyber security

Federal authorities in most of the countries have strict regulations on patients’ healthcare data and its governance. Thus, CROs carry the huge burden of data security. As the organization’s enterprise architecture is designed for more scalability, it brings an intrinsic challenge of handling more vulnerabilities. A dedicated and diverse group of security experts must prepare a ‘secure by design’ policy for the organization. An integrated and comprehensive approach for securing the organization data is extremely necessary.

Accomplishing desired results

The model of decentralized clinical trials is dependent on a strong technology foundation. These trials are patient-centric and inclusive and bring diversification in testing. DCTs help reduce time in bringing new medicines and drugs to the market. A thoughtful application of technology can support in driving desired results.

About the author

Rutuparn Paratkar
Rutuparn Paratkar is a Senior Consultant and Business Relationship Manager at TCS. He has over 21 years of experience working with global customers across geographies in business domains of life sciences, healthcare, investment banking, finance, and corporate functions. He has led several initiatives in realizing IT strategy for his client CIOs in cloud transformation, modernizing data platforms, establishing end-to-end IT support, team building, and managing large and diverse IT portfolios in TCS. He is a Certified Agile Coach and has coached over 300+ professionals in agile by conducting "Living Agile Sessions" across various industry verticals. He lives in North Carolina, USA.