Just like early startups, I believe that small and midsize biotech, life science, and medical device companies serve as the crucibles of innovation in the medical field. However, the needs of these small and midsize pharmaceutical companies differ greatly from those of big pharma or similar organizations with established products on the market.
Those familiar with the industry know that, unlike startups—which often benefit from tools and programs tailored to their size and scale—the life sciences and drug discovery sectors have not yet embraced this same level of customization. Although hundreds of clinical trial management tools exist, many are not designed with small and midsize life science companies in mind. There is an excessive focus on developing and servicing big pharma, which is surprising given that, according to data from ClinicalTrials.gov, big pharma only conducts about 40% of the registered clinical trials. The remaining 60% is divided among academic research institutes and smaller life sciences/biotech companies. In fact, SMB pharma still accounts for more than 50% of clinical trials conducted for INDs, over 70% for medical devices, and 30% for vaccines.
With these numbers in mind, one cannot help but wonder why these trailblazing companies are forced to use tools designed for large, resource-rich organizations. Many of these platforms—often referred to as Clinical Trial Management Software (CTMS) or Clinical Trial Solutions for Small Businesses—are rigid, expensive, and laden with unnecessary features and poor user experiences. This makes them a poor fit for smaller companies that require agility, cost efficiency, and tailored functionality. In contrast, a user-friendly CTMS and scalable clinical trial platforms designed specifically for small and midsize life science companies could drive significant improvements in clinical trial management optimization.
In this article, I share my observations as a relative newcomer to this space and propose a new approach that addresses the unique challenges and opportunities faced by small and midsize biotech and pharmaceutical companies. By focusing on cost-effective clinical trial software for SMBs, we can bridge the gap between the needs of innovative small companies and the current solutions built for big pharma.
Problems
Problems
- Over-Engineered Complexity:
Most legacy CTMS platforms are built to accommodate the extensive regulatory and operational needs of large enterprises. This results in overly complex systems with steep learning curves, redundant functionalities, and a high level of customization that small companies rarely need. The one-size-fits-all model not only overwhelms users but also limits productivity for teams that require simpler, more intuitive interfaces. Additionally, many existing platforms enforce a closed ecosystem that restricts customization and forces companies into long-term contracts. This lack of flexibility stifles innovation and makes it difficult for companies to pivot or adapt their software to changing market conditions and trial requirements, ultimately impeding future growth. - High Costs and Limited Flexibility:
Traditional solutions often come with hefty licensing fees and implementation costs. Small and midsize companies, which typically operate on tighter budgets, struggle with these financial burdens. These platforms are frequently inflexible, offering limited options for scaling down or adapting to the specific workflow and regulatory demands unique to smaller organizations. A cost-effective clinical trial management software solution designed for SMBs could alleviate these issues by providing essential functionality without unnecessary bloat. - Lack of Agility and Integration:
Many existing systems are built on outdated architectures that do not integrate well with modern tools. In an era where data interoperability and real-time analytics are paramount, these systems hinder the seamless flow of information across departments and third-party services. This lack of integration capability forces companies to rely on manual workarounds, leading to inefficiencies and an increased risk of errors. Agile clinical trial solutions and user-friendly CTMS platforms designed for small and midsize life science companies would better support rapid deployment and continuous evolution with growth.
The Over “Tech-ification” of Clinical Trials
I cannot talk about these problems without addressing a major elephant in the room. The over “tech-ification” of clinical trials.
Obviously this may seem ironic coming from someone building a technology solution in space, but when you think of it, clinical trials have been traced as far back as the 1500’s. The first clinical trial can be traced to 1537 when Surgeon Ambroise Paré accidentally conducted a clinical trial when he ran out of boiling oil to treat battlefield wounds. Instead, he used a mixture of egg yolks, rose oil, and turpentine. The soldiers who received the new mixture healed better than those who received boiling oil. I don’t think Excel or AI aided much when James Lind conducted a controlled clinical trial to determine if citrus fruits could cure scurvy in 1747 either.
The point i am driving at here is that, do clinical trials needs the hundreds of platforms that currently exist offering all these single use solutions? Maybe they do. Studies have become increasingly complex and regulated which necessitates some of these solutions but why is there a single solution for each of these processes and sometimes multiple solutions to perform these tasks? And do all these solutions cost as much as they do?
This is a rhetorical question.
Solutions
Now that I have spent enough time complaining, let me provide what I think are a few simple solutions that i think people working in this space(myself included) should consider and we plan for the next phase of clinical trials management tools may look like especially for SMB life science companies.
- Big pharma tends to have established processes and can afford the inertia of large, rigid systems. Their scale allows them to manage complex workflows and regulatory requirements even with less agile technology. In contrast, small and midsize pharmaceutical companies must move quickly to bring innovative treatments to market. They need agile clinical trial solutions that can adapt to rapidly changing protocols, regulatory environments, and emerging scientific data.
- With larger teams and specialized roles, big pharma can manage complex software systems with dedicated IT and operations departments and may tolerate steep learning curves if the system meets broad, multifaceted needs. However, small and midsize life science companies require user-friendly CTMS platforms that are intuitive and easy to learn, enabling faster deployment and higher productivity.
- Budget constraints are a significant challenge for SMB pharma. These companies need cost-effective clinical trial software that doesn’t compromise functionality. A scalable CTMS allows them to start with essential features and add capabilities as their trials grow or new needs emerge. By focusing on affordable, scalable clinical trial management systems, small and midsize biotech and pharmaceutical companies can better manage their resources while optimizing trial processes.
Conclusion.
While I may be somewhat naive in my perspective, there is no disputing that recognizing and addressing the distinct needs of SMB pharma—financial prudence, agility, user-centric design, and integration—paves the way for more effective clinical trial management solutions. By building tailored, cost-effective clinical trial software for SMBs and adopting agile, scalable platforms, developers can empower small and midsize life science companies to innovate more rapidly and compete effectively in an evolving, competitive landscape.