Effectively launching a clinical trial is a complex endeavor no matter the size of a company or the allocated budget. In theory, a clinical trial shouldn’t differ from company to company. The process, like that of any scientific experiment, is the same time and time again.
However, carrying out a clinical trial when belonging to a large global corporation is very different to when you are operating as a small biotech with limited resources and a very tight budget, both in terms of cash and manpower.
The ability for biotechs and small pharma to effectively and efficiently carry out a clinical trial depends on their ability to create opportunities for dynamic change. All this while maintaining competitiveness and flexibility, and building on their agility over larger competitors.
Leveraging the Expertise of Vendors
It’s essential smaller companies leverage their position to pose a challenge for established companies in the industry. This is especially pertinent given the recent announcement by Amazon, Berkshire Hathaway and JP Morgan to enter the pharmaceutical arena and potentially disrupt business as we know it. Consequently, small pharma is perfectly positioned to challenge the established old order and offer something which board members and customers alike can benefit from.
To achieve this, small pharma can benefit from the expertise of vendors and service providers who have the in-house expertise to address challenges within the supply chain that are commonplace in their day-to-day dealings. Vendors have the perfect platform to demonstrate to their clients how to escalate trials globally, while assisting them with software solutions that can simplify this process, and ensure small pharma is in a position to maximize its limited resources to achieve positive trial results.
Furthermore, the adoption of said technology has the ability to enable small pharma and biotech to quickly respond and adjust when unforeseen changes arise in their supply chain.
Adopting and Implementing IRT
IRT technologies are another area which can give small companies a competitive advantage over their larger competitors. Solution providers in this area are quickly innovating and designing systems that can simplify a clinical supply director’s job by facilitating their ability to manage supply chain complexities while adhering to stricter regulatory oversight by U.S. and European regulators.
While many see the investment in IRT as a costly one, this tool is much better positioned to manage all aspects of the supply chain than programs, such as Excel or EDC. Adopting and implementing IRT into your current clinical supply chain cuts overall costs by minimizing IP waste, improving drug monitoring, and expediting expiry date processes.
Another area where small pharma can leverage its position to expedite pipeline development lies in its fluid organizational structure. Smaller companies have the ability to prevent organizational silos developing, which are commonplace in larger corporations, and minimize the likelihood of adding significant administrative burdens on a company’s operating systems.
Taking a Leaf out of Big Pharma’s Playbook
However, small pharma should at the same time take a page out of large pharma’s playbook and improve their internal processes by mimicking their standardized supply processes. This is critical to ensure all trials are being benchmarked against the same metrics and standards. By following the accountability structure of large pharma, small pharma can springboard off a tried and tested platform to achieve sustained and continuous growth. This can ensure a company’s ability to expand and grow beyond the next clinical trial.
Overall, small pharma and biotechs are in a prime position to challenge the behemoths in the industry. Given that unlike their larger competitors, small pharma are not subject to a top-down hierarchy of decision-making, as a result, they can quickly adapt to the changing pharmaceutical landscape. This comes at a time when three of the America’s top companies have decided to dip their toe into the pharmaceutical industry and have the ability to, not only disrupt the industry, but change how companies operate in this space. As such, by leveraging their flexibility and drawing on their fluid organizational structure, small pharma can credibly contest established companies while bringing new lifesaving therapies to market.