HealthcareHow can CROs hit timelines by using fit-for-purpose technology?

Contract research organizations (CROs) are companies that help to manage and conduct clinical trials for the pharmaceutical, biotechnology, and medical device sectors. With the life sciences industry rapidly growing in complexity and scale, CROs face increasing pressure to deliver high-quality results within watertight trial timelines and budgets, while consistently adhering to uncompromising regulatory requirements. This article considers how CROs can meet timelines by using fit-for-purpose technology.

The challenges of clinical trial timelines

According to research published in the Medical Sciences Journal¹, participant recruitment is one of the most challenging aspects of any clinical trial, directly impacting both the study duration and the quality of trial results. Approximately 80% of clinical trials fail to meet their initial enrollment target and timeline², with factors such as lack of awareness, logistical barriers, geographical location, trial accessibility, and regulatory barriers often compromising a trial’s ability to recruit and retain participants. Failing to recruit enough eligible participants willing to commit to a clinical trial can result in significant delays and financial losses and can compromise the validity of trial results.

As international multi-site clinical trials become more common, conformity with complex protocols and regulatory guidance is another growing challenge to clinical trial timelines. Regulations vary by geographic location, and regulatory bodies in different regions may see variations in concepts such as adverse event reporting, data privacy requirements, and clinical trial approval processes. This regulatory challenging landscape makes it extremely difficult to implement the same trial protocol across all study sites, leading to considerable delays and associated cost implications.

Every day that a trial is delayed adds to the overall operational costs, including ongoing site management, staffing, and extended timelines for data analysis and reporting. The TUFTS Center for the Study of Drug Development conducted a study³ that determined that a single day of delays within a clinical trial is estimated to cost $40,000 in direct daily costs, and $500,000 in unrealized drug sales.

Cost implications, including revenue loss, are just one way delays impact trial sponsors. Prolonged timelines may lead to reduced confidence from stakeholders and investors, which can impact funding and the company’s market valuation while giving competitors the chance to bring similar drugs to market faster. For CROs, extended delays in trial management can limit company resources, meaning they are unable to take on new projects and risk their reputation in the process.

Last but certainly not least, delayed access to innovative treatments may result in participants missing the chance to access potentially life-saving therapies.

Leveraging technology for efficient patient randomization and trial supply management

Rapid advancements in AI and technology have enabled clinical trials to leverage digital technology to enhance clinical trials’ quality and integrity, helping CROs meet their targets and stay on track with pre-determined study timelines and data management. Digital technology is becoming a key component in clinical trial execution, allowing CROs to automate their supply chain and participant randomization processes. Randomization and trial supply management technology (RTSM) ensures timely delivery of trial supplies and can both automate and optimize supplies sent to sites. Adaptable RTSM settings can support trial supply goals, including reducing drug wastage and keeping shipments and carbon emissions to a minimum, in addition to saving time on stock monitoring effort.

Fit-for-purpose technology in clinical trials refers to the design and implementation of tools and systems specifically optimized to meet the needs of clinical studies, supporting the management of compliance with global regulations, and helping CROs manage complex documentation. Fit-for-purpose technology can ensure that not only does the system meet the needs of the protocol when the first patient is enrolled, it can flex and adapt to protocol amendments and operational challenges. By using fit-for-purpose technology, CROs can align user-friendly technology and the seamless integration of multiple systems with their specific needs and trial design.

The use of real-time data visualization dashboards and predictive analytics helps CROs to anticipate and mitigate risks, enhances communication between sites, sponsors, and CRO teams, and allows them to solve issues quickly through faster and more informed decision-making. Technology can reduce administrative burden and the risk of human error, as well as reduce unnecessary clinical trial delays and improve global participant outcomes.

Partnering with fit-for-purpose technology suppliers empowers CROs to navigate the complexities and challenges of today’s clinical trials. By investing in fit-for-purpose technological solutions, tailored to their operational needs, CROs can hit clinical trial timelines, enhance trial efficiency, save money, and continue to bring much-needed, life-saving, therapeutic options to participants faster.

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Resources

1. Medical Science. Successes and Challenges in Clinical Trial Recruitment: The Experience of a New Study Team. https://pmc.ncbi.nlm.nih.gov/articles/PMC11348161/
2. Journal of Medical Internet Research. Online Patient Recruitment in Clinical Trials: Systematic Review and Meta-Analysis. https://pmc.ncbi.nlm.nih.gov/articles/PMC7673977/
3. Therapeutic Innovation & Regulatory Science. New Estimates on the Cost of a Delay Day in Drug Development. https://link.springer.com/article/10.1007/s43441-024-00667-w