CRO for Decentralized Clinical Trials – The Future of Research, Delivered by ProRelix Research
In a world where time-to-market can determine the success or failure of life-changing therapies, decentralized clinical trials (DCTs) have rapidly evolved from a novel concept to a strategic necessity. These patient-centric, digitally enabled trials have unlocked new possibilities—connecting science with real-world participants in ways previously unimaginable. With a sharp rise in remote technologies and increasing demand for accessibility, the traditional clinical trial model is giving way to one that is agile, inclusive, and scalable.
At the forefront of this transformation is ProRelix Research—a global Contract Research Organization (CRO) that combines scientific expertise, regulatory intelligence, and cutting-edge digital platforms to power decentralized clinical trials across all therapeutic areas and phases.
The Paradigm Shift: Why Decentralization Matters
Decentralized clinical trials represent a fundamental shift in how research is conducted. Instead of expecting patients to travel long distances to centralized trial sites, DCTs bring the trial to the patient—through telemedicine, digital monitoring tools, home healthcare services, and secure online platforms. This model not only improves patient convenience and recruitment diversity but also accelerates timelines and enhances data quality.
However, DCTs are inherently complex. Sponsors need a CRO partner with proven experience, deep regulatory understanding, and the infrastructure to orchestrate every moving part across regions. ProRelix Research is uniquely positioned to meet these demands.
Why ProRelix Research?
At ProRelix Research, we don’t just implement decentralized trials—we design them with intention, execute them with precision, and optimize them for meaningful outcomes. Our capabilities span the full lifecycle of DCTs, from early feasibility and protocol development to real-time data capture, remote monitoring, and regulatory navigation.
We understand the nuances of hybrid and fully virtual trial designs and provide tailored solutions that align with your therapeutic goals, patient population, and global footprint.
Our DCT Capabilities: Powering Research Beyond Boundaries
Decentralized Study Design and Strategic Planning
Every successful DCT begins with a sound strategy. At ProRelix Research, we meticulously analyze your trial objectives, study endpoints, patient demographics, and geographic scope to assess the appropriateness and scalability of decentralized components. Our teams ensure that trial designs not only meet scientific and clinical goals but also align with global regulatory expectations. We provide comprehensive DCT feasibility assessments, develop contingency plans, and integrate digital workflows from the outset to streamline execution.
We also help sponsors select the right hybrid model—fully virtual, partially decentralized, or site-supported—depending on indication complexity and patient safety considerations.
Home Health Visits and Mobile Medical Teams
The cornerstone of a patient-centric DCT is care delivered at the doorstep. ProRelix Research manages a global network of trained mobile healthcare professionals who conduct trial procedures at patients’ homes, reducing the need for site visits and increasing participation among rural and mobility-challenged populations.
We support everything from routine vitals collection and investigational product administration to adverse event assessments and biological sample draws. All home visits are coordinated with digital logistics systems that ensure proper temperature control, sample labeling, and protocol adherence. Patients receive care on their terms, with full clinical oversight and quality assurance.
ePRO, Wearables, and Continuous Data Capture
Our decentralized trials leverage patient-reported outcomes (ePRO) and wearable devices to collect high-resolution, real-time data directly from participants. These tools provide insight into a patient’s daily health status, behavior, and quality of life—offering rich datasets that reflect the therapeutic impact in real-world settings.
We deploy validated digital tools compatible with smartphones, tablets, and wearables. Data is encrypted, timestamped, and integrated into centralized dashboards for immediate analysis. With our system, sponsors gain a continuous, uninterrupted view of trial progression—enabling early detection of safety issues or therapeutic responses.
Global Regulatory and Compliance Expertise
With regulators increasingly embracing decentralized models, navigating the evolving guidelines becomes critical. ProRelix Research has a dedicated regulatory affairs team that works closely with sponsors to ensure every element of the DCT complies with international and local regulations—including FDA, EMA, MHRA, DCGI, TGA, and Health Canada frameworks.
We manage regulatory submissions for decentralized technologies, coordinate with IRBs/ECs to gain approval for digital tools, and ensure full compliance with patient privacy laws such as GDPR and HIPAA. Our early engagement with regulators supports faster approvals and minimizes protocol amendments during trial conduct.
Cardiology
In cardiology research, our decentralized models utilize mobile ECG devices, wireless BP monitors, and remote telemetry tools to capture cardiovascular data with clinical-grade accuracy. Patients are equipped with user-friendly devices that sync directly with our central data platform, minimizing data latency. With nurse-assisted home visits and secure video assessments, we closely monitor cardiac endpoints such as heart rate variability, arrhythmia detection, and medication effects—especially in chronic heart failure or post-MI patients who require long-term follow-up.
Endocrinology
We empower endocrine trials through the deployment of remote glucometers, continuous glucose monitors (CGMs), and wearable devices that track metabolic parameters. Our DCT model ensures daily data capture, behavioral logging, and automated alerts for glycemic excursions—critical in diabetes, thyroid dysfunction, and metabolic syndrome studies. Telehealth consultations with endocrinologists allow for real-time dose adjustments, while educational tools improve patient self-management and protocol compliance from home.
Rare Diseases
Rare disease trials face unique hurdles, including limited patient populations and geographically dispersed participants. ProRelix Research addresses this through telemedicine access to specialized investigators, home-based genetic sample collection, and virtual support communities that improve engagement. We coordinate international regulatory compliance, logistics for investigational products with cold chain needs, and multi-language eConsent systems. These trials demand agility and precision—two qualities we bring to every rare disease DCT initiative.
Digital Recruitment and eConsent That Connects
Recruitment is one of the biggest challenges in clinical research, but in decentralized models, it also becomes one of the biggest opportunities. We use a data-driven approach that includes social media campaigns, geo-targeted advertising, AI-enabled eligibility screening, and partnerships with patient advocacy groups to identify and engage the right participants at the right time.
Our eConsent platform goes beyond electronic documentation. It includes video explanations, interactive FAQs, and multilingual support, ensuring that patients truly understand their participation. The result is a transparent, patient-empowered onboarding process that leads to higher retention and compliance rates.
Telemedicine and Virtual Trial Hubs
Through secure telemedicine platforms, we replicate the critical functions of an investigator site while eliminating geographical constraints. Investigators can conduct virtual assessments, respond to patient inquiries, and manage safety signals from a centralized hub.
Patients benefit from direct access to physicians and site staff through scheduled video consultations, eliminating travel costs and reducing barriers to participation. Our virtual infrastructure allows for seamless documentation, audio-video archiving, and integration with eCRF systems to ensure that all patient interactions are tracked, compliant, and auditable.
Remote Monitoring and Centralized Oversight
To ensure high-quality data and patient safety, ProRelix Research utilizes advanced remote monitoring systems. Our centralized risk-based monitoring (RBM) platform identifies trends, triggers alerts, and helps site monitors prioritize activities based on real-time risk assessments.
Our CRAs are trained in virtual monitoring protocols, including SDV verification through secure screen-sharing, digital audit trail evaluations, and remote site file reviews. This approach significantly reduces monitoring costs, increases inspection readiness, and ensures that data quality is upheld across decentralized environments.
Therapeutic Breadth, Decentralized Depth
we understand that a one-size-fits-all approach doesn’t work in clinical research—especially in decentralized trials. Each therapeutic area comes with its own set of scientific, logistical, and regulatory complexities. Our DCT solutions are purpose-built to adapt to these challenges, offering disease-specific innovations that ensure both participant well-being and data integrity. With a blend of digital tools, home-based services, and expert oversight, we craft customized decentralized models across diverse therapeutic domains to meet your clinical objectives without compromise.
Oncology
We bring DCT solutions to oncology trials by enabling symptom tracking, electronic patient diaries, and home-based specimen collection. These measures support patients undergoing intensive therapies who may be immunocompromised or too fatigued to travel. Our team ensures safe handling of biologics and toxic materials during home visits, maintaining strict adherence to GCP and biosafety standards. Teleconsultations with oncologists and integration with ePRO tools allow for continuous monitoring of patient well-being, treatment tolerance, and adverse events in real time.
Neurology
Neurology trials often involve patients with movement, cognitive, or speech limitations. Our decentralized solutions include virtual cognitive assessments, wearable sensors for gait and tremor analysis, and remote data submission from EEG/EMG devices. For diseases like Alzheimer’s, Parkinson’s, and multiple sclerosis, our approach allows for longitudinal tracking of subtle functional changes. Caregivers are also supported with training and telehealth resources, creating a collaborative, home-based care ecosystem that enhances study retention and data fidelity.
Immunology and Infectious Diseases
For immunology and infectious disease trials, especially those involving vaccines or immune-modulating therapies, we implement decentralized models that support rapid enrollment and safety surveillance. Mobile phlebotomy, eDiary-based symptom tracking, and integration of diagnostic kits at home ensure protocol adherence and timely AE reporting. Our remote infrastructure also allows real-time communication during outbreaks or public health emergencies, supporting trials in challenging or quarantined environments without compromising patient safety.
Why Sponsors Choose ProRelix Research for DCTs
Rapid Patient Enrollment
We unlock access to a much broader population through geo-targeted digital outreach, AI-powered patient matching, and online advocacy partnerships. This results in faster site activation and enrollment timelines, even for complex trials.
Superior Retention and Adherence
By removing logistical burdens and empowering participants with mobile tools, we see improved adherence to dosing schedules, fewer missed visits, and higher overall data completeness. Personalized communication and concierge-style patient support further enhance engagement.
Accelerated Timelines and Faster Insights
With real-time data collection and centralized monitoring, sponsors can make faster decisions and adapt trial parameters dynamically. This reduces the average duration of a study and expedites time-to-market for new therapies.
Diverse and Inclusive Data
Decentralized methods help overcome long-standing barriers to enrollment faced by elderly, rural, or underserved populations. Sponsors gain access to more diverse data sets, which better reflect real-world efficacy and safety outcomes.
Reduced Operational Costs
Without the need to maintain physical sites, hire large on-site teams, or reimburse patient travel, decentralized models offer significant cost savings. ProRelix Research helps you reallocate those savings into patient support, digital analytics, and expanded reach.
Comprehensive, End-to-End Partner
From feasibility and digital tool selection to home care logistics and final database lock, we serve as your single-source partner for every component of your decentralized trial. Our integrated approach ensures consistency, accountability, and alignment with your vision.
The ProRelix Commitment: Human-Centered, Innovation-Driven
At ProRelix Research, we believe that decentralization is not just about technology—it’s about people. It’s about enabling science to meet participants where they are, without compromise. We are proud to be at the helm of this evolution, ensuring every trial we support is accessible, equitable, and powered by purpose.
Our mission is to redefine clinical research by merging operational excellence with compassionate delivery—making it faster, smarter, and more inclusive than ever before.
Take the Next Step with ProRelix Research
If you’re exploring decentralized trials or ready to transform your next study into a digital-first experience, partner with ProRelix Research. Our expertise, infrastructure, and commitment to quality will guide you every step of the way.
