The Global Clinical Trials Management Challenges
- myLaminin
- Mar 16
- 4 min read
By 2026, the global clinical trials market will have grown significantly in size and complexity. It is no longer restricted to just discovering new treatments. Clinical trials are currently at the intersection of science and government regulations, international politics, and data security. As more money is invested in life sciences and novel healthcare ideas, the way clinical trials are conducted, monitored, and kept safe becomes as crucial as the medicines or protocols being evaluated.
Market Size and Momentum
The global clinical trials market is expected to grow significantly. According to Yahoo Finance, it is believed to be worth USD 99.21 billion and is projected to expand at a CAGR of 6.51% between 2026 and 2035.
The reason for this expansion is the tremendous growth in therapies under development. And with the introduction of AI, there is tremendous growth across every discipline of medicine.
Novel remedies must be evaluated in a structured way. All these trials must be conducted to rigorous regulatory standards to ensure participant safety and data privacy. More often than not, much of this research is in collaboration with peers in other institutions and potentially cross-jurisdictional. This creates challenges for PIs and their teams while increasing institutional data management risks.
When it comes to trial spending and trial volume, the clinical trials sector remains dominated by North America and Europe, collectively accounting for over 80% of active commercial clinical trial sites. However, Asia-Pacific, Latin America, and some sections of Africa are receiving increased attention. This is because the people doing these studies aim to involve a diverse range of participants while also completing the trials as quickly as possible. Clinical trials are no longer limited to one location, they now take place all over the world. As a result, clinical trials have increasingly become international collaboration efforts.
However, when it comes to what is going on in the market, growth is not the focus. What is truly crucial is the nature of the shift, rather than its magnitude. Clinical studies are increasingly more difficult to manage.
Complexity Is the New Normal
A single clinical trial is likely to involve many organizations, such as hospitals and universities, and must obtain ethics board approvals from a variety of entities to ensure that everything is carried out safely, equitably, and according to jurisdictional regulatory standards.
These organizations include laboratories that are not part of the primary institution, corporations that assist with research, and individuals who ensure that regulatory standards are obeyed.
The collection of clinical trial data, ideally in a digital format, is a major operational challenge and contributor to cost. All participant data, images, lab results, and clinical trial team member actions, reviews, and sign-offs must be diligently and securely recorded.
These policies and regulatory requirements put a great deal of responsibility on PIs and their teams, who are accountable for adherence to all applicable jurisdictional standards. The mere task of delegating authority to conduct certain procedures by a clinical trial team member is a key and important part of ensuring that delegation authorities are appropriate for the procedures that are part of the clinical trial protocol.
Where a complete Clinical Trial Management System (CTMS) is not available to the research team, this may pose significant inefficiencies, opportunities for administrative errors, and operational strain on the researchers and administrators.
As researchers undertake more genomics and AI-related research, the management of data in cross-jurisdictional contexts becomes more difficult and increases risks for both the clinical trial team members and their institutions.
Data Integrity and Security Take Center Stage
When conducting trials, PIs must deal with sensitive PHI data and potentially valuable intellectual property. Researchers cannot afford to have this information leaked or lost, or to have difficulty determining how it was derived, or who may view it.
Researchers are choosing platforms that enforce and facilitate good data governance hygiene which is critical to the success of their research endeavors, platforms like myLaminin.
Looking Forward
Regulatory oversight is driving the shift to more automation, electronic consent, and digital signatures to ensure rigorous data governance, adherence to ethical standards and approved protocols, as well as applicable jurisdictional frameworks.
Researchers and institutions that can readily adapt to jurisdictional and regulatory standards, maintain participant safety, and data privacy are likely to be well positioned to capture more grant funding.
At myLaminin, we are already detecting that many of the PIs on our platform conducting clinical trials need a platform to effectively manage their team’s operational needs, define and execute structured clinical trial protocols consistent with HIPAA/PHIPA, GCP and 21 CFR Part 11 guidelines, and ensure data security and seamless cross-jurisdictional data sharing.
As the market continues to grow and evolve, the question is no longer whether clinical trials will become more global and data-intensive, instead the question is whether the systems supporting them are ready to support this type of activity.
CTMS is not just project management software, it is the operational backbone of trusted, compliant, and secure clinical research.
Sources
Davis, S. (2024). Clinical trial footprint in BRICS: Improvements seen but needs further affirmative action. Perspectives in Clinical Research, 15(3), 105. https://doi.org/10.4103/picr.picr_109_24
Precedence Research. (2026, January 22). Clinical Trials Market Size to Reach USD 175.02 Billion by 2035. Yahoo Finance. https://finance.yahoo.com/news/clinical-trials-market-size-reach-103100827.html
