If you’ve watched any of the track and field events at the Olympics, you’ve likely been blown away by the lightning-fast reflexes of an Olympic sprinter. In order to be among the fastest runners in the world, these athletes must follow an extremely regimented training program to ensure they are physically and mentally prepared for the biggest day in their athletic careers. Every muscle must be finely tuned and every thought must be focused, ensuring they are ready to spring into action the moment the starting gun fires.
In the fast-paced world of clinical trials, sponsors need to be just as agile, quick to react, and adaptable to changing circumstances. Because of the importance of our industry’s work, the race is against time — not just competitors. The ability to move swiftly and efficiently through the complex maze of biospecimen operations can be the difference between success and setback. Like an athlete dodging hurdles, sponsors who can navigate obstacles with speed and precision are the ones who reduce delays and accelerate study timelines.
But why is this speed and agility so crucial for sponsors, especially for competitive and resource-constrained biotechs? And why should biospecimen operations be a primary focus for sponsors looking to fast-track their clinical trials? Let’s delve into the reasons why moving swiftly in your biospecimen operations is not just an advantage, but a necessity.
Why does speed and agility matter in biospecimen operations?
Patient samples are the backbone of most of the data that is generated for clinical research; therefore, the way in which these samples and their associated data are managed and tracked across various sites and lab vendors makes biospecimen operations a critical focal point for impacting the overall efficiency of a clinical trial.
So why should speed and agility be a priority for sponsors when it comes to their biospecimen operations? It turns out there are a number of reasons.
- They’re in a competitive market: Sponsors — especially biotechs — operate in an intensely competitive environment where being first to market can make a significant difference in market share and profitability. The biotech landscape is especially populated with numerous players racing towards similar goals. Sponsors that can streamline their biospecimen operations and reduce trial timelines gain a first-mover advantage, capturing market attention and establishing their innovations as industry standards.
- They can benefit from expedited regulatory approval: Speed and agility in clinical trials aren’t just about getting to the finish line first — they’re also about meeting crucial regulatory milestones on time. The faster a sponsor can generate high-quality data, the sooner they can submit it to regulatory bodies like the FDA for review. Swift, accurate data submission can expedite regulatory processes, potentially leading to faster approvals and quicker market entry.
- They want to be pioneers in clinical research: Sponsor organizations are driven by innovation and the constant pursuit of new knowledge. The quicker a sponsor can move through the various trial phases, the sooner they can iterate and innovate on their products. Speed and agility allow sponsors to adapt to new scientific information as it emerges during a trial, enabling them to refine their approach and push the boundaries of their research. Being a pioneer means staying ahead of the curve, and that requires the ability to react swiftly to new data and evolving research landscapes.
- They have limited people resources: Unlike large pharma companies, biotechs often operate with lean teams, making it essential to maximize the efficiency of every team member. Speed and agility in biospecimen operations mean that smaller teams can achieve the same high standards of execution as larger organizations. Technology that streamlines and automates traditionally manual processes becomes a force multiplier, enabling sponsors to do more with less. This not only helps them meet aggressive study timelines, but also allows them to allocate resources more strategically.
- They have limited financial resources: Financial constraints are a reality for many sponsors — especially biotechs. Delays in clinical trials can be extremely costly, consuming valuable resources and potentially jeopardizing the entire study. By prioritizing speed and agility, sponsors can reduce overhead costs associated with extended study timelines. Demonstrating the ability to conduct efficient and timely trials also boosts investor confidence, which is crucial for securing ongoing funding.
- They need to improve data quality through proactive decision-making: The sooner sponsors can act on biospecimen operation activities and trial data, the sooner they can make proactive decisions that improve the overall quality of their studies. Real-time data access allows for quick adjustments, ensuring that the trial stays on track and produces reliable, high-quality results. By being able to react quickly to data insights, sponsors can finetune their study designs and avoid issues that could compromise data integrity.
What’s at stake for sponsors if they aren’t quick and agile in managing their biospecimen data and operations?
Unfortunately, the stakes are high for sponsors who aren’t able to make speed and agility a priority when managing their biospecimen data and operations.
- They might lose out on first-mover advantage: In the competitive clinical research landscape, being first to market is often crucial. Delays in biospecimen operations can result in competitors reaching the market first, capturing market share, and establishing their products as the standard of care. Missing out on this advantage can be a costly setback, both in terms of financial returns and the opportunity to set the industry benchmark.
- Their financial health is at risk: Study delays can inflate costs, strain budgets, and deplete financial resources. For biotechs with limited funding, this can be devastating. Inefficiencies and delays not only increase the financial burden but can also decrease investor confidence, making it harder to secure the necessary funding for future trials. Maintaining a rapid pace in biospecimen operations is crucial for protecting the financial health of the company.
- Patients are impacted: The human cost of delays in clinical trials cannot be overlooked. Slower trials mean that patients must wait longer for potentially life-saving or life-enhancing treatments. This is particularly consequential for those suffering from rare or aggressive diseases, where time is of the essence. The ability to accelerate trial timelines can make a tangible difference in patient outcomes, providing hope and improved quality of life for those in need.
- Trying to make up for lost time caused by delays hurts data quality: When delays occur, there is often a rush to make up for lost time. This hurried approach can compromise data quality, leading to gaps in data for primary and secondary endpoints, and increasing the risk of non-compliance with regulatory requirements. Rushed processes towards the end of a trial can jeopardize the outcomes of regulatory reviews and submissions, further delaying approval and market entry.
- Their reputation could take a hit: Reputation is everything in clinical research. Consistently slow or delayed trials can damage a sponsor’s reputation within the industry, making it harder to attract partners, sites, and patients for future studies. Slow progress can also erode trust with key stakeholders — including investors, partners, and even patients — affecting the company’s long-term prospects.
Slope can get your trials over the finish line at record speed
Slope’s biospecimen lifecycle software, Biospecimen360™, is designed to empower sponsors with the speed and agility needed to stay ahead in a competitive landscape. By streamlining biospecimen operations and providing real-time access to critical data, Slope enables quick decision-making, reduces trial timelines, and enhances overall efficiency. Whether you’re managing complex workflows or responding to unexpected challenges, Biospecimen360™ ensures you can navigate the intricacies of clinical trials with precision — bringing life-saving and life-changing treatments to market faster.
Slope's Professional Services are designed to complement our Biospecimen360™ software, providing sponsors with expert guidance and hands-on support. Our team of industry specialists become extensions of your study team, helping you optimize your biospecimen operations and ensuring that your trials are conducted with precision and efficiency. From pre-vendor selection to study closeout, Slope's Professional Services help you navigate complex challenges, streamline workflows, and accelerate timelines, so you can focus on delivering life-changing treatments to patients.
To learn more about our software and services, click here to speak with an expert.