Sponsored By Seriant Oct 27, 2025 8:00am
Clinical development is undergoing a structural shift. Protocols are growing more complex, budgets are shrinking, and expectations from regulators, payers, and patients continue to rise. Meanwhile, investors are demanding greater capital efficiency. In this high-pressure environment, every decision about trial design, execution, and location carries greater consequence.
What was once a linear process of designing a protocol, recruiting patients, generating data, and submitting for approval has matured into an interdependent ecosystem of scientific, operational, and financial considerations. Traditional approaches alone can no longer keep up.
Building a Broader Toolkit for Success
Every source of delay, from protocol amendments to inconsistent data, translates into direct expenses and indirect costs such as lost opportunity, shortened market exclusivity, and reputational risk. Sponsors that fail to anticipate these pressures risk losing capital and credibility with key stakeholders.
To manage this complexity, sponsors must adopt a broader toolkit. That includes pragmatic designs, robust data integration, early statistical involvement, and strategic use of location. Geography, infrastructure, and trial design are no longer separate decisions; they are interconnected levers that can reduce risk and drive value.
- More Diverse Study Populations
Decentralized and hybrid trial models can help reduce barriers to participation and broaden access to under-represented populations. By lowering the burden of travel and time, these models make it easier for more people to enroll and remain in studies, resulting in data that better reflects real-world diversity and yielding more generalizable results.
Digital tools such as electronic consent forms, electronic patient-reported outcomes (ePROs), and telehealth can improve convenience and may support more timely and complete data capture. However, the use of these tools introduces complexity and variability through multiple data sources, formats, collection methods, and diverse populations. Preparing the data for analysis requires modern data management practices and experienced teams to integrate diverse datasets while ensuring integrity and regulatory compliance.
Finally, diversity extends beyond participants to the data itself. Modern trials increasingly integrate results from labs, wearables, and other connected devices. When governed, standardized and aligned with privacy requirements, these data enhance signal detection and improve the real-world relevance of study results.
- Endpoints and Methods
Selection of endpoints and methods are central to trial success. Biostatistical and medical expertise shapes protocols from the earliest stages: sample size determination, statistical approach (e.g., frequentist vs. Bayesian) and methodology, and defining endpoints that reflect clinical reality while satisfying regulators, payers and patients. Pragmatic elements added to explanatory trials increase value by capturing real-world insights without compromising rigor.
- Infrastructure for Insights
Pharmacogenomics centers and large biobanks provide powerful infrastructure for identifying genetic markers, stratifying patients, and discovering predictive biomarkers. These assets reduce development risk by anchoring decisions in human biology, allowing researchers to select targets and patient groups with a higher probability of success.
Published literature shows that genetically supported mechanisms increase success probability by a factor of 2.6, and drug targets backed by human genetic evidence are twice as likely to succeed in clinical development.
- Scale with Agility
Global reach is critical for recruitment and generalizability, but scale without agility can lead to inconsistency and inefficiency. Flexible delivery models, efficient oversight, and strong data management are essential to operating across regions while maintaining quality.
- Geography as strategic multiplier
Geography influences not just logistics, but also cost, speed, and access to infrastructure. Incentives in one country can complement those in another, and certain regions offer regulatory and financial advantages that directly impact clinical timelines and budget.
Canada provides a clear example: Health Canada’s 30-day Clinical Trial Application (CTA) process follows a fixed 30-day review with no ‘stop the clock’ provisions offering a more predictable and faster start than U.S. and EU, respectively. The federal Scientific Research and Experimental Development (SR&ED) program offers 15%–35% tax credits, and provincial programs such as Québec’s new tax credit for research, innovation and commercialization (CRIC) can further reduce net costs.
Perhaps most importantly, Canada’s public research ecosystem enables partnerships that commercial sponsors alone cannot access. Clinical Research Organizations (CROs) operating within Canada’s innovation-driven healthcare network can serve as co-applicants on federal and provincial grants, including CIHR, NSERC, MEDTEQ+, and Mitacs, opening the door to non-dilutive funding that can be used strategically.
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Regulatory Environment Health Canada’s Clinical Trial Application (CTA) process operates on a fixed 30-day review period with no ‘stop the clock’ provisions, |
Federal R&D Tax Support The Scientific Research and Experimental Development (SR&ED) tax incentives program (15%–35% tax credits), offsetting trial costs regardless of outcome. |
Provincial Incentives Various programs can combine with federal SR&ED to significantly reduce net costs |
Academic Partnerships Academic contract research organizations (CROs) can serve as co-applicants on Canadian federal and provincial grants (e.g. MEDTEQ+, CIHR, |
The MEDTEQ+ Impact program provides collaborative funding of up to $1.5 million CAD (approximately $1.08 million USD) over three years, covering up to 40% of eligible project expenses for academic and clinical partners in Quebec, supporting innovation and derisking in clinical trials.
The New Foundations of Competitive Clinical Development
The margin for error in clinical development has narrowed. Sponsors who align scientific innovation, operational discipline, and geographic strategy will be best positioned to succeed. By embracing diverse populations, smarter endpoints, advanced infrastructure, and location-based advantages, sponsors can reduce risk, improve efficiency, and deliver more credible evidence to regulators, payers, and patients.
Seriant is a full-service Clinical Research Organization (CRO) with over 25 years of experience supporting pharmaceutical, biotech, and medtech sponsors from Phase 1 to Phase 4. Our Montreal-based operations are strategically integrated within Canada’s research infrastructure, unlock non-dilutive funding opportunities and enable streamlined execution, while our global reach ensures both operational scale and scientific rigor across regions.
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Contact Seriant to help you de-risk and accelerate your next trial.
The editorial staff had no role in this post’s creation.