For life sciences companies, clinical trials play a crucial role in ensuring the safety and efficacy of new therapies, drugs, and medical devices. They are the most pivotal step in determining whether a product will reach the hands of a patient—making it critical for clinical trial managers to execute them flawlessly and as quickly as possible.
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Poor management of clinical trials can lead to delays and increased costs. As many as 45% of clinical trials are completed late and approximately 80% of trials fail to meet their initial enrollment targets on time, according to IQVIA research.
Effective clinical trial management can help reduce the time required for drug development and regulatory approval, enabling drugs to reach the market sooner. Any time savings makes a huge difference in bringing new and potentially life-saving treatments to patients sooner. Accelerated time to market can also help improve the financial performance and reputation of the sponsoring organization.
Let’s examine advice and strategies to improve speed, manage costs, and ensure compliance during the clinical trial process.
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Getting a clinical trial study and associated sites up and running effectively is often a laborious and disjointed undertaking. To avoid slowdowns, clinical trial managers must boost efficiency by streamlining startup activities. This can include automating handoffs between teams, tracking document and contract statuses, automating regulatory submissions, and more. Doing so will increase process quality and prevent unnecessary rework, leading to improved chances of clinical study success. Consider automation for site feasibility and selection, site activation, and interactions and document exchange with investigators.
Clinical trials generate a vast amount of data, and managing this data efficiently is crucial for trial success. Slow or inefficient data collection and management practices can lead to data errors, increased costs, and delays in data analysis. To avoid this slowdown, clinical trial managers should implement effective data collection and management solutions. Look for capabilities like data fabric, which can create an intelligent digital organization and give you a 360-degree view of all enterprise data.
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Effective communication and collaboration between all stakeholders are critical for trial success. Slow or poor communication and collaboration can lead to misunderstandings, delays in decision making, and decreased quality of trial data. To avoid this, clinical trial managers should establish clear lines of communication between all stakeholders, including cross-functional study teams, investigators, sponsors, and regulatory agencies. Leverage a solution with enhanced collaboration capabilities to help. Look for a technology that can automate handoffs between stakeholders and improve data sharing with a data fabric.
Clinical trials are often the most expensive component of research and development. Any cost savings can make a monumental difference in the drug development process. Consider these three best practices to implement for more cost-effective clinical trial management.
A well-designed study can minimize unnecessary costs by reducing the number of study subjects required, decreasing the length of the study, and limiting the number of procedures needed. Improved workflow across study design tasks can eliminate unnecessary process slowdowns and cut down costs throughout. For example, automating process handoffs between functional teams across study planning speeds up interactions across those activities.
Streamlining clinical trial processes can help reduce costs by eliminating redundancies and inefficiencies. This can include simplifying data collection and entry with automated, pre-populated fields, automating menial tasks to reduce workload for trial staff, and standardizing processes such as patient screening and adverse event reporting.
Data monitoring is a critical component of clinical trial management, and real-time monitoring can help reduce costs associated with monitoring activities. Automated systems can monitor and identify issues by analyzing data in real time. Real-time monitoring can provide early detection of issues and reduce the need for on-site monitoring visits, which can be costly.
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As clinical trials become more complex and the demand for speed increases, it can be challenging to balance the need for speed with the need for compliance. Apply these strategies for managing clinical trial compliance concerns as you increase speed:
Let’s examine how clinical trial management systems can help with those concerns as well as speed and cost challenges.
To execute a speedy and effective clinical trial, look for a clinical trial management solution that can eliminate process slowdowns while providing the visibility and control needed to keep operations on track and meet compliance standards.
Trial workers often switch between clinical trial management systems (CTMS), electronic data capture (EDC), clinical data management systems (CDMS), electronic trial master files (eTMF), and various SharePoint sites to find information. This can slow down the trial, increase the risk of human error, and compromise compliance.
It’s important to implement a solution that enables seamless collection, management, and analysis of data from multiple sources in the context of a business process. Look for capabilities such as data fabric, which can help you discover, unify, secure, and optimize data across your organization. A data fabric gives you a 360-degree view of critical data to help you make informed decisions—and to allow your teams to collaborate more efficiently.
Automating routine tasks such as data entry and verification, patient recruitment and retention efforts, and adverse event reporting can help reduce the workload for trial staff and improve trial efficiency.
Look for a platform that offers workflow orchestration. A good workflow orchestration tool will make it easy to use automation capabilities, structure task flows, and manage the interactions between human workers, data, and digital workers. Additionally, a solution with process mining capabilities can provide visualizations of process data, allowing you to identify areas for improvement and automation. By leveraging process mining, you can make data-informed decisions on how to continuously optimize your processes, maximizing both efficiency and effectiveness.
With a process automation platform, you can enhance monitoring and reporting by incorporating analytics, reports, and dashboards. This enables you to track essential performance metrics, such as patient enrollment and adverse events, and generate real-time reports. This enhanced visibility empowers trial staff to identify potential issues early on and take proactive measures to prevent trial setbacks. Real-time reporting can also promote accurate data sharing with regulatory bodies, increasing compliance assurance throughout the trial and enhancing the chances of successful approval for the next stage of development.
Effective clinical trial management is crucial for life sciences companies to ensure timely and cost-efficient development of new therapies. Slow study startup, inefficient data collection, and poor communication can lead to delays and increased costs. To improve speed and reduce expenses, streamlining processes, innovating study design, and implementing real-time data monitoring are key. Additionally, selecting a comprehensive clinical trial management system that enables seamless data collection, process orchestration, and end-to-end trial visibility can significantly enhance efficiency and compliance. By implementing these strategies, organizations can accelerate the delivery of life-saving treatments to patients while also optimizing resources.
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