May 13, 2024 | Procurement Software
Clinical trials are the backbone of innovation in the pharmaceutical and biotechnology sectors. The global market for these essential activities is expected to exceed $78 billion by 2030.
While the COVID-19 pandemic underscored the urgent need for accelerated development in this field, significant barriers hinder progress. These include inefficient governance, inconsistent contracting practices, prolonged approval times and inadequate technological integration.
Such issues not only lead to exorbitant costs but also compromise the quality and timing of trials, significantly impacting public health outcomes.
For instance, the average clinical trial is delayed by over 12 months, potentially increasing costs by $600,000 to $8 million per incident.
This article highlights three focus areas that pharma companies must look to improve to ensure that clinical trials are successful and cost- and time-effective.
Effective management of clinical trials begins with robust governance and streamlined stakeholder interaction.
To optimize operations, pharmaceutical companies must reevaluate and fortify their organizational structures. This effort includes defining clear roles and responsibilities for all stakeholders involved, from R&D teams to external partners.
By refining governance frameworks, companies can enhance decision-making efficiency, particularly in critical areas such as budgeting and contracting.
For example, simplifying these processes can drastically reduce time-consuming bureaucratic hurdles, leading to faster trial initiation and reduced costs.
The second pivotal area for optimization is process management. Pharma companies should focus on automating routine and complex workflows alike to reduce the likelihood of errors and inefficiencies that can stall trials.
Automation not only expedites administrative tasks but also ensures consistency and compliance across all stages of the trial.
Furthermore, establishing rigorous key performance indicators (KPIs) and a real-time performance dashboard is crucial. These tools help in monitoring ongoing processes, measuring their effectiveness, and swiftly addressing any deviations from expected timelines or budgets.
This systematic tracking and assessment facilitate proactive management of the trial process, ensuring milestones are met on schedule and within budget.
Also Read: Digital Transformation in Clinical Trials
The integration of advanced technologies , particularly artificial intelligence (AI) and decentralized databases, is essential for modernizing clinical trials.
AI applications can revolutionize trial design by predicting outcomes, optimizing patient recruitment, and enhancing data analysis. This not only improves the accuracy of trials but also accelerates the pace at which they can be conducted.
Additionally, adopting decentralized database systems allows for better management and security of patient data, supporting real-time data access and compliance with global regulatory standards.
By leveraging these technological advancements, pharmaceutical companies can ensure that trials are more adaptable, efficient, and capable of handling complex datasets, thereby speeding up the time to market for new therapies.
Transforming clinical trial operations is not a one-size-fits-all process. Each pharmaceutical company faces unique challenges and operates within different regulatory environments. Therefore, it is crucial for each organization to embark on a customized transformation journey that addresses its specific needs and strategic goals.
By focusing diligently on improving governance, optimizing processes, and leveraging technology, companies can significantly reduce the risks associated with delays and non-compliance. More importantly, these strategic enhancements enable pharmaceutical companies to realize substantial long-term value, align their operations with industry best practices, and maintain a competitive edge in the rapidly evolving healthcare landscape.
This strategic focus is not merely about overcoming operational hurdles but also about enhancing the efficacy, speed, and impact of clinical trials in improving patient outcomes worldwide.
To learn more, get the GEP white paper How Pharma Companies Can Optimize Clinical Trial Operations and Unlock Value