From Academia to Industry: How University-Led Trials Are Professionalizing
- Vafa Javadova
- Mar 29
- 4 min read
For a long time, clinical trials have always been the purview of major pharmaceutical firms and reputable research institutions. Many academic institutions have historically lacked the operational infrastructure necessary to conduct complex clinical trials independently, despite the fact that universities play a crucial role in scientific discovery in the early stages, producing discoveries in university labs.
Today, that dynamic is rapidly changing. These institutions want to be involved in the entire process, and rightfully so. As a result, academic research institutions are beginning to adopt operational practices that resemble those used in industry.
Hence, university-led trials are professionalizing.
The Rise of Academic Clinical Trials
Numerous innovations that have transformed our lifestyles have originated from academic laboratories where scientists carry out preliminary experiments.
For instance, insulin was discovered at the University of Toronto in 1921 by Dr. Frederick Banting and Charles Best. Nevertheless, though the discovery and preliminary research of insulin was conducted at the University of Toronto, the clinical work beyond the early-stages was moved outside of the university. This occurred because the university did not have the infrastructure to run trials from beginning to end.
Even today, the scale and complexity of clinical research continues to expand significantly. Some developments that have contributed to more complex research environments include:
The rise of international clinical trials
Integration of digital technologies such as wearable devices and electronic health records
Larger volumes of clinical and patient data
Increased regulatory frameworks
Rapid advancements in Artificial Intelligence
These demands require structured operational frameworks, which academic research environments have historically lacked.
Universities have to adapt to these changes and as a result, these institutions are increasingly investing in professional clinical trial infrastructure to support the growing scope of the research space and their own research activities.
What Professionalization Looks Like in Practice
To actually professionalize their clinical trials, academic institutions are beginning to adopt the structures, processes, and technologies that have long defined industry-sponsored research.
One major change is the move toward centralized research infrastructure. Rather than having various workspaces for teams to manage their own workflows, universities are establishing dedicated systems to support clinical trial operations across departments. This includes standardized processes for research planning, participant tracking, obtaining consent, data collection, and reporting. Centralizing these functions in one database with set rules and frameworks allows for consistency and reduced inefficiencies across trials.
Another key development is the emphasis on everything data-related. With the increasing volume of clinical data, telehealth, and IoMT devices combined with the sensitivity of clinical data, universities must ensure that their processes and supporting infrastructure are regulatory-compliant, this information is securely stored and properly documented. Platforms and data environments must deliver regulatory compliance, access controls, audit trails, and allow for long-term storage.
Compliance and regulatory alignment are a crucial part of this transformation. In order to obtain sponsors, funding, and to publish findings, research must meet a variety of regulatory frameworks. This includes meeting HIPPA (in the U.S.), PHIPA and PIPEDA (in Canada), and GDPR (in Europe) regulatory requirements.
Technology is Enabling This Shift
As briefly mentioned, advancements in technology are a key enabler of this transportation. In the past, clinical trial data could only be collected in-person, often in labs, and always face-to-face. Nowadays, researchers and Clinical Trial (CT) Coordinators can perform the entire clinical trial or research process remotely from start-to-finish. This process could include participant recruitment, gathering consent online, using digital surveys to collect data, and using electronic health records.
Furthermore, the management of research is changing due to the development of artificial intelligence (AI). AI-powered solutions can help with things like data monitoring, which could reduce the dependence on administrative supervision or CT Coordinators.
When taken as a whole, these advancements are enabling universities to carry out clinical studies with a level of coordination and efficiency that was previously limited to commercial settings.
Closing the Gap
Universities have always been at the forefront of innovation, producing novel ideas, conducting pilot studies, and advancing scientific knowledge. To carry these results through the whole research lifecycle, however, outside partners with industry expertise have always been required.
This gap is becoming harder to maintain, particularly as clinical research gets more complicated and technology-intensive.
To truly support modern research, universities need tools that enable start-to-finish execution. They need a platform that allows them to manage:
Study design
Data collection
Consent forms
Regulatory compliance
Multi-faceted and international collaboration
Version-controls and tracking
Long-term data storage
This is where Research Data Management (RDM) platforms play a critical role. Platforms such as myLaminin are built to connect the entire research lifecycle into one place. The myLaminin CTMS module supports clinical trial protocol definition, data collection, participant follow-up, eTMF, PI review with 21 CFR Part 11 compliant signoff, delegation log, and audit trail. myLaminin allows institutions to manage data, documentation, collaboration, and compliance within a single, secure environment. Overall, this platform enables universities to operate clinical trials with greater efficiency, transparency and control, making sure that universities cross the finish line.
CTMS is not just project management software, it is the operational backbone of trusted, compliant, and secure clinical research.
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Vafa Javadova (article author) is a myLaminin intern, and studying Management and Organizational Studies (BMOS) at Western University.
