Transitioning from the information age into the digital era, Elixir Clinical Research stands at the forefront of the industry, daring to break the boundaries of conventional thinking and explore unknown paths as a pioneer. On December 11, 2023, Elixir Clinical Research significantly launched the "iECR Digital Intelligence Center" (hereinafter referred to as "iECR Center"), aiming at transforming traditional service models with intelligence and taking another important step on the path to digitalization.

Adapting to the Times and Environment

Darwin's theory of evolution reveals that in times of significant environmental changes, it's not necessarily the strongest or the smartest who survive, but those who can rapidly adapt to the environment. Amidst the digital transformation wave, Elixir Clinical Research adapts to the situation by empowering with science and technology, and actively advancing two agendas: firstly, accelerating the depth of its own digital application, transitioning into a digital and intelligent enterprise committed to providing clients with higher quality, faster, and more efficient services to expedite the drug approval process; secondly, integrating into clients' digital transformation, delving into pharmaceutical company clients' operational scenarios to aid their transformation and development.

The iECR Center was born in this context.

Riding the favorable wind, the launch coincides with the national government's release of the "Plan for the Overall Layout of Building a Digital China". Digital transformation has become an inherent need across all industries. To effectively advance the achievement of the goal of digital transformation, Elixir Clinical Research utilizes digital thinking, methods, and tools. It focuses on its functional positioning, integrates scattered tools, collects dispersed data, and combines traditional business models with individual application systems to form a composite solution with a business mainline supplemented by system tools.

Reshaping Service Models

The iECR Center is not just about online business processes; it's a composite innovative solution centered on digital technology applications, aiming at "using intelligence to change traditional service models". The subtlety behind this lies in three key terms:

First is "Connecting Dots to Form Lines"

It aggregates various tools for clinical trial execution and management, offering a unified login portal, integrating TrialOS, ERP, and tools developed by Elixir Clinical Research itself.

Second is the "Strategy Intelligence Hub"

Based on clinical project experience, the Center recommends using CDE project data as the primary source, supplemented by the company's past project data, CRA maintenance data, and supplier research data, to forge a central strategy repository, which is dedicated to making informed choices based on past experiences. By inputting key project requirements such as indications, the central strategy repository can directly output center experience rankings, enabling horizontal comparisons of centers' key abilities like enrollment rate and start-up rate, to identify the preliminary selection of centers; and then it will output PI experience rankings to initially determine the recommended PIs, thus providing a list of recommended centers with a faster speed and more accurate information.

Third is "Taking Robots as Intelligence Assistant"

Automatic robots are introduced to implement repetitive, cyclical, and logical tasks, transforming past work into a pattern of standard operating paths with robot execution and minimal staff supervision, which reduces operational costs and improves execution accuracy, thus forming a digital capability-driven execution liberation solution provider.

RPA Robots: Digital "New Colleagues"

Embracing changes and facing challenges require a full understanding of those challenges. The number of adverse events in clinical drug trials is rapidly increasing, and the cost control challenge for pharmacovigilance (PV) departments is becoming more severe. CROs like Elixir Clinical Research, with limited manpower, are struggling to cope with the growing workload and urgently need to break through productivity bottlenecks with digital technology capabilities. The iECR Center's RPA is particularly useful for routine, high-frequency repetitive tasks in PV.

RPA (Robotics Process Automation) is a software-based technology designed to automatically execute repetitive, regular, and predictable business processes or tasks. Essentially, it simulates manual operations and executes corresponding tasks on a terminal, for example, operating Word, Excel spreadsheets on a computer, or performing data processing in a system, logging into websites for clicking, searching, etc.

RPA has multiple advantages in PV work. On one hand, it can replace manual processes, significantly reducing input errors, improving work efficiency, and cutting costs. On the other hand, it is highly scalable, capable of operating around the clock (24 × 7). Even during periods of peak demand and traffic, the team can still maintain service levels and meet regulatory requirements.

Within just one month, Elixir Clinical Research has successfully applied RPA to several labor-intensive report processing tasks with high workload. This has effectively resolved the contradiction between clients' high-quality demands and low budgets, reducing manual labor by approximately 37%, improving efficiency by 50%, and significantly lowering the error rate due to human factors. The effect was immediate and evident. Currently, full-process automatic robots have been developed and successfully applied to certain projects, helping clients effectively reduce labor costs and save budgets while ensuring quality.

Although the advantages of RPA are clear, there are still limitations. In the execution of complex tasks, RPA cannot realize automated generation independently and still relies on human-robot collaboration to identify, judge, make decision on, and solve complex problems. There is also a need for collaborative efforts to establish a complete data protection mechanism for RPA applications, ensuring data security and avoiding compliance risks. Nonetheless, there is no denying that the potential application scenarios for RPA are vast and largely untapped.

eQuality System: Quality Upgrade, Prevention First

Problem management is oriented towards solving problems, while identifying, articulating, concluding, and dealing with issues are regarded as clues and entry points. It is important to effectively identify critical problems, give priority to prevention and combine prevention with elimination. By managing through problems at the same time of solving the problems, risks can be effectively avoided, thus achieving upgrades in quality and management.

Based on this, Elixir Clinical Research has established the eQuality system at the iECR Center. As a system for clinical research quality management, it can provide customized, standardized, and programmatic clinical trial audit processes and CAPA management processes for issues. It can also independently evaluate trial quality, reduce risks, improve protocol compliance and GCP compliance, and establish an informationized QA system.

The eQuality system is currently being tested for adoption, and is estimated to be completed and launched by the end of this year. Stay tuned!

In the vast landscape of the digital economy, Elixir Clinical Research takes a longer view and is intensifying its efforts in scientific and technological innovation. The creation of the iECR Center marks a significant tool and strategy for the digital and intelligent transformation of the pharmaceutical industry. It breaks down the data silos of the chimney-style management in the past, comprehensively enhancing capabilities in information operation, data mining, and agile application. This advancement aims to achieve intelligent management and optimization in the drug development process, thus improving the quality and safety of drug research and development. In building a service framework, Elixir Clinical Research offers clients smarter and more automated services, opening up new prospects in digital development together and sharing the new dividends of the digital wave.

For more details, please contact 

info@ecr-global.com