For clinical research organizations (CROs) and the broader pharmaceutical industry around the world, drug development remains a complex and costly process spread across multiple sites. Clinical trials form an essential part of this process, lasting many years and costing millions of dollars. A core aspect of the exercise is collecting study-related data across various sites, subjects and other dimensions.
As the complexity of trials continues to increase amid more stringent regulations, the need for sourcing, aggregating and storing clean, credible data is vital. So is the need to provision faster access to this data for various enterprise users for better informed, agile decision making.
As a result, many industry players are turning to cloud-based Electronic Data Capture (EDC) systems for the collection and analysis of clinical data across global sites. Many of these sites are spread across developing countries with limited access to medical infrastructure and regulatory approval processes. Stakeholders involved across the study lifecycle can overcome the roadblocks posed by limited communication and collaboration tools by deploying digital tools such as EDC platforms. Apart from replacing the conventional method of collecting trial data through paper forms, EDC eliminates the need for notoriously difficult site visits to gather and ascertain test data.
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The effectiveness with which complex data spanning multi-site clinical trials can be gathered, analyzed and shared with relevant stakeholders ultimately determines the safety and efficacy of new drugs in the pipeline. EDC systems provide dynamic tools that pharma companies can integrate with their existing systems and utilize the same for defining studies, capturing data and managing the same for assessing study results.
The benefits offered by EDC platforms are manifold – they enable data-driven monitoring that provides transparency and actionable insights at all stages of a specific trial. This streamlined data can be sorted through with the click of a few buttons, an added impetus that enhances the efficacy of complex trials. Such solutions are primarily built with the objective of simplifying workflows and delivering better user experiences for patients.
EDC systems are steadily becoming indispensable for researchers as they simplify complex clinical trials while remaining easily accessible from a user standpoint. Another compelling aspect of such systems is the real-time visibility they offer into the massive amounts of data being collected at every stage of trials.
Researchers who undertake complex trials for developing new-to-market drugs or showcasing the safety of long-term medications for chronic ailments are also implementing EDC solutions in-house to make trials simpler and less expensive. This can be done by opting for cloud-based EDC platforms that involve relatively lower upfront capital expenditure and minimal maintenance issues. Moreover, such implementations reduce the trial timelines for researchers.
As the integration of EDC software with other digital eClinical applications such as randomization, supply management and adverse event reporting systems gathers pace, the pharma industry is realizing the imperative to design and implement customized EDC. Doing so would boost their ability to swiftly source digital data from sources including electronic health records and lab reports.
And with independent standards like CDISC that help classifying and sharing trial data gaining traction alongside open-source EDC software, the various stakeholders involved in the trial lifecycle will be able to make their research studies more productive, agile and cost-effective.
In any clinical trial, data is a critical component that can significantly impact the entire project in terms of end-to-end turnaround time, costs, and efficiency. Today, with technological advancements powering clinical data management, it may in fact even have a role in determining the overall success of a project.
For clinical research organizations (CROs) and the broader pharmaceutical industry around the world, drug development remains a complex and costly process spread across multiple sites. Clinical trials form an essential part of this process, lasting many years and costing millions of dollars.
Leading pharma regulators such as the U.S. FDA continue to impose, and enforce, strict compliance standards with regard to approval of new drugs. The U.S. watchdog’s strict vigil means that for every new medical device or drug securing market release, thousands get rejected – cumulatively representing billions of dollars, and years of research.
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