The clinical trial space is notoriously difficult – it’s like trying to climb an impossibly difficult mountain that gets steeper and steeper without a summit. As these trials evolve, so do the challenges faced by the stakeholders conducting those trials.
The clinical trial space is a highly complex terrain. Most of the challenges, however, do not fundamentally involve clinical research. Instead, roadblocks involve a strategic, logistical, and administrative intensity that requires a delicate and nuanced approach. Any misstep can be catastrophic for the trial.
So, let’s look at a few challenges facing contemporary clinical trials.
Complexity
As a result of the diverse stakeholders in the clinical research space, it’s no surprise that complexity features on the list. Each aspect of the trial comes with a series of requirements to support, cumulatively adding complexity.
Moreover, legal parameters surrounding clinical research are intensely rooted in compliance. This adds additional layers of complexity for each destination in which the clinical trial is held. Argentina, for example, has demanding customs specifications that can delay projects and drastically increase lead times, especially without in-depth knowledge of the requirements.
Finally, the complexity of evolving tools in data collation and informatics. These are essential in the context of the contemporary trial space but add to the complexities that challenge medical trials.
Regulation
Predictably, in an industry fraught with rigid frameworks, regulation features often on the list of challenges faced by those within the clinical trial space. Many pharmaceutical trials are hindered purely by the bureaucratic guidelines of global regulatory requirements.
Additionally, different requirements by various regulatory bodies add more challenges to the already rugged terrain. From import compliance and customs regulations to research parameters and institutional reviews, regulation is a massive challenge facing clinical trials today.
Costs
As a result of the decentralization of global trials, the cost of clinical trials is historically high. Trials are becoming more and more time and resource-intensive, rendering them comparatively expensive.
Additionally, introducing controls at every intersection has resulted in compounded costs and stretched timelines. It’s become essential to mitigate potential mistakes at every intersection to keep costs down – as a result, many trials outsource logistics and compliance to ensure smooth interactions and limit unforeseen errors.
Time Demands
From developing a trial design to regulatory approval and funding, every aspect of a medical trial demands its own time parameters.
Collectively these can contribute to lagging and expensive pharmaceutical trials. The key to a smooth and efficient trial is streamlined project management – effectively and concurrently running operations every step of the way.
Governance
The clinical trial supply chain and strategic partnerships are playing a more and more vital role in the trial space. However, these partnerships require logistical project management that can prove challenging. Ultimately governance in the clinical trial space is a massive challenge but can prove endlessly priceless to performance and profitability by implementing the correct partnerships and engaging with the right stakeholders.
TecEx assists CROs, CMOs, Sponsors, and Vendors with risk-free import, export, and customs compliance solutions. So, tie those laces, pack plenty of provisions, and get ready for the trek because while it may be difficult, there are a host of service providers, like TecEx, to help you through the clinical trial journey.
