The transformation of the clinical trials industry is no longer a hypothesis — it is already a reality. Digital technologies, increasingly complex sponsor requirements, and the need to include more diverse patient populations have accelerated the shift from the traditional, site-centric model toward hybrid and decentralized formats.
📌 Traditional clinical trials have served their purpose. For decades, they were the backbone of research, leading to essential medical breakthroughs. But today’s reality demands more: speed, accessibility, scalability, and a truly patient-centered approach.
In this new context, traditional research sites face a strategic choice: adapt or risk becoming irrelevant. This is not just about digital tools or protocol changes — it’s about a deep shift in mindset, where flexibility, connectivity, and patient focus become core performance drivers.
Hybrid trials have emerged as a balanced solution between conventional research and modern technologies that enable remote participation. Yet for many legacy sites, this model remains abstract — or even intimidating. How does a hybrid study work in practice? What new responsibilities does it bring? What changes are needed in infrastructure, staffing, and operational workflows?
Without staying in the theoretical zone, this article clarifies the key elements every traditional research site should understand in order to transition successfully to hybrid trials and remain a trusted partner in modern research networks.
1.Why Hybrid Trials Are Becoming the New Industry Standard
The traditional model of clinical trials — centered exclusively on in-person site visits — is not disappearing, but it’s no longer sufficient in an ecosystem that demands speed, accessibility, and adaptability. Hybrid trials, which combine on-site components with remote activities, have emerged in recent years as a balanced solution, offering both the rigor of direct oversight and the flexibility of digital tools.
This transition didn’t happen overnight. The COVID-19 pandemic acted as a major catalyst, accelerating the adoption of telemedicine, eConsent platforms, wearable devices, and remote data collection methods. What began as a crisis response has proven to be, in many cases, a structural improvement in the way trials can be designed and executed.
Hybrid trials offer clear benefits to all stakeholders:
Moreover, hybrid models support greater representation of the general population by removing geographic and social barriers that traditionally limited access to research. Regulatory authorities such as the FDA and the EMA have begun issuing updated guidance that actively supports the implementation of decentralized elements in trial design.
As these advantages become increasingly evident, fully traditional models are being phased out in favor of more agile approaches. In 2024, the question is no longer if sites should adapt — but how.
2. What Hybrid Trials Require from Traditional Research Sites
Adopting a hybrid model is not just about adding digital components to an existing structure. For traditional research sites, true transition involves a fundamental rethinking of how clinical trials are designed and operated.
🔹 2.1. Expanding the Role of the Study Coordinator
In hybrid trials, the coordinator is no longer just a documentation administrator. They become a true operations manager — orchestrating both on-site visits and remote activities, managing real-time communication with patients and medical teams, and integrating data from multiple sources (digital platforms, wearable devices, ePRO, etc.).
This expanded role requires:
🔹 2.2. Integrating Digital Infrastructure
Traditional sites that want to remain relevant must implement functional digital components: eConsent, eSource, telemedicine, EDC systems, and remote monitoring tools. Having the technology is not enough — it must be:
Without a minimal, functional digital architecture, hybrid implementation risks being shallow and resource-draining.
🔹 2.3. Adapting the Team to a New Type of Interaction
Transformation is not just about technology — it's about people. Research teams must be prepared to manage virtual interactions with patients, monitors, and sponsors, use new platforms effectively, and embrace more flexible, decentralized workflows.
This shift requires:
🔹 2.4. Building Integrated Collaboration with Sponsors and CROs
In a hybrid model, the relationship between sites and sponsors/CROs becomes more complex and interconnected. Activities are no longer purely sequential or local — they are distributed across teams, platforms, and timelines. Sites that succeed in this context are those that:
Sponsors are also starting to evaluate sites based on digital and operational maturity, not just recruitment speed. Effective collaboration in hybrid trials requires the ability to respond quickly, document accurately, and integrate feedback in real time.
Adopting a hybrid model isn’t about “adding platforms.” It’s about rethinking relationships, roles, and internal structures.
Sites that understand these deeper — not just technological, but cultural — shifts are the ones that remain part of modern research networks and become trusted long-term partners.
3. What Traditional Sites Must Concretely Implement
The transition to hybrid trials doesn’t happen overnight, nor does it require massive upfront investment. But it does require a structured, realistic approach tailored to each site's capabilities. Traditional centers that succeed in this transformation aren’t necessarily the ones with the most resources — they are the ones that know how to prioritize and implement changes progressively.
🔹 3.1. Technology: A Minimal Functional Digital Infrastructure
The first concrete step is establishing a solid digital foundation. There are three essential components for any site aiming to implement a hybrid model:
These technologies don’t need to be deployed all at once. Many sites begin with eConsent — a solution with immediate impact and relatively low investment — and expand progressively as operational capacity grows.
🔸 Important: Each technology must be validated, interoperable, and compliant with local regulations (e.g., GDPR, GCP).
🔹 3.2. Operational Processes Adapted to Hybrid Reality
Technology without process is useless. Sites that aim to be reliable hybrid partners must redesign their operational workflows to support both on-site and remote activities. This includes:
Without this process foundation, the risk of errors, misalignment, and operational bottlenecks increases exponentially.
🔹 3.3. Continuous Training and Digital Skills Development
Transitioning to a hybrid model isn’t just a technical upgrade — it’s a cultural shift. And that shift must be supported by a coherent professional development plan. High-performing sites invest in:
Coordinators and investigators who know how to operate in a mixed environment become strategic assets in any research network.
4. Common Mistakes to Avoid When Transitioning to the Hybrid Model
Moving from a traditional to a hybrid model isn’t just a technical upgrade — it’s a complex transformation that carries real risks, especially when approached superficially, hastily, or without a coherent strategy. Many of the difficulties sites encounter during transition don’t stem from lack of resources, but rather from misguided decisions made early on.
🔹 4.1. Overestimating Technology Without Operational Readiness
One of the most common mistakes is a “tool-based” approach: implementing digital platforms rapidly without redesigning internal processes and responsibilities.
eConsent, ePRO, and EDC systems are only tools — and without clear procedures and cohesive internal organization, these technologies often create operational chaos rather than efficiency.
A site that introduces digital tools without aligning workflows, training the team, or redesigning the patient interface quickly risks failure — or may even be dropped from a study by sponsors.
🔹 4.2. Lack of a Phased, Strategic Rollout Plan
Transformation only works when it's planned in phases. Many sites make the mistake of attempting “full digitalization” right away, without prioritization. This approach drains budgets, overwhelms teams, and generates internal resistance.
Successful sites start with:
A phased approach allows for real learning, adaptation, and validation — without excessive pressure.
🔹 4.3. Underestimating Team Resistance to Change
Another major pitfall is assuming that staff will simply “adapt” to new processes. In reality, transitioning to a hybrid model means changing the daily habits of coordinators, investigators, and support staff.
Without involving the team from the planning phase:
Successful transformation only happens with the team, not imposed on it.
5. What Sponsors Expect from Sites Involved in Hybrid Trials
In today’s environment, the relationship between sponsors and research sites is no longer purely transactional. With increasingly complex protocols and mounting pressure on timelines and costs, sponsors now select their partners based not only on availability, but on the site’s real capacity to operate effectively in hybrid models.
Sites that succeed in becoming trusted partners are those that understand sponsor expectations go beyond technology — they are also operational, procedural, and cultural.
🔹 5.1. Standardization, Scalability, and Adaptability
Sponsors seek sites with clear, reproducible, well-documented processes that are easy to scale. In multi-site or global trials, a center with strong SOPs, the ability to manage multiple studies simultaneously, and agility in responding to changes becomes a strategic asset.
Scalability doesn’t just mean having more beds or patients. It means:
🔹 5.2. Connectivity and Digital Interoperability
A high-performing site in a hybrid trial must be able to work in real time with sponsors, CROs, and external technology systems. This includes:
Sites that operate on the same “digital level” as sponsors are more likely to be selected for repeat studies.
🔹 5.3. Genuine Patient Focus and High-Quality Deliverables
Finally, sponsors value partners who understand that the patient is at the heart of the hybrid model. Sites that ensure:
are the ones that directly contribute to trial success and faster validation of results.
Hybrid clinical trials are not a passing trend. They represent a deep and irreversible shift in how clinical research is conducted. In this new reality, traditional sites are not required to become fully digital — but they are required to become smarter, more adaptable, and more connected.
The transition to a hybrid model is not about acquiring technology. It’s about rethinking internal processes, training teams, building strong collaboration with sponsors, and adopting a genuine patient-centered mindset. Sites that understand these priorities and take progressive, structured action don’t just remain relevant — they become indispensable partners in modern research.
Sites that adopt these models early have the opportunity to become preferred "early adopters" for sponsors, strengthening their strategic position in the ecosystem.
📌 Survival in today’s clinical research ecosystem is no longer defined by the ability to start a study, but by the ability to complete it — quickly, correctly, and with high-quality data.
📣 To what extent do you believe traditional clinical trial sites are truly ready to transition toward hybrid studies?
From your own experience, what are the biggest barriers: infrastructure, mindset, or lack of clear support from sponsors?
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