Authors: Kunal Dubey, Associate Director, Life Sciences & Vibhav Jain, Business Analyst, Life Sciences
Life sciences organizations have emerged from COVID-19 pandemic into a new environment for conducting Randomized Clinical Trials (RCTs). While the pandemic is not the only driver, it solidified five key industry trends accelerating the adoption of modern clinical data management methodologies and technologies.
Industry drivers: current state of clinical research data management
Sourcing clinical data is a primary operation in RCTs. These sources and how they are managed are changing fundamentally. Life sciences organizations and Contract Research Organizations (CROs) are looking to capitalize on these industry drivers and harness the technology key to streamlining clinical operations, workflows, and accelerating time-to-market.
Distributed sites of clinical data collection
Clinical research came to a grinding halt during the initial days of the pandemic until teams created virtual and distributed approaches to continuing their investigation. Those same tools have opened and increased the number of sites where research data are collected.
Greater number of clinical data sources
Data sources continue to increase beyond in-clinic, one-on-one collection via personal interactions. Today, data sources include mobile and smart devices and apps, patient-reported outcomes (PROs), direct electronic data entry, or EHR data transfer.
Need for a clear line of sight and auditability with validation
With new data sources and sites for data collection, it’s more critical than ever that researchers can trace, audit, and validate data easily and reliably.
Global offshore CRO outsourcing growth
More CROs are outside the U.S., and their use is increasing, particularly when labor costs are lower, patient populations are more readily available, and technology adoption is high.
Cost and speed pressures for greater efficiency
COVID-19 research, and vaccine development broke the mold for speed-to-market and set a new bar for life sciences organizations. These cost and speed pressures necessitate novel approaches to achieve greater efficiency, safety, efficacy, and cost controls.
Building an RCT using FHIR-based eSource data provides better quality, more traceable data sources faster, synergistically level up value throughout the RCT operations. When combined, these approaches can accelerate patient enrollment and site activation processes, reduce the overall clinical trial cycle time, and provide faster access to research data for more rapid decision-making.
As a global team that supports healthcare and life sciences organizations, CitiusTech offers sophisticated, proven technology solutions and experience of subject matter experts. Our dedicated team of industry professionals and clinical domain experts, coupled with our end-to-end data management capabilities, teams and tools, enables CROs and pharmaceutical companies to realize a modern clinical research strategy based on eSource, interoperability, and automation.