**TrialKit for Site-Based Clinical Trials**

The only mobile-native EDC to power your in-person clinical research.

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What Are Traditional Site‑Based Clinical Trials?

In traditional clinical trials (also called site‑based trials), study participants travel to physical clinical sites (hospitals, clinics, or research centers) for visits, assessments, and procedures. All measurements, imaging, lab draws, clinician assessments, and monitoring typically happen on-site, under controlled conditions.

These trials remain foundational in drug development, device testing, and therapeutic validation. They offer tight procedural control, direct oversight, and standardized environments that help ensure data consistency, compliance, and clear regulatory traceability.

While decentralized and hybrid models are growing, many clinical questions—especially those requiring in-person assessments, biosample collection, or specialist procedures—still depend heavily on site‑based trials.

Challenges in Traditional Site‑Based Trials

Even site-based trials are not without friction. Common challenges include:

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High site burden

Staffing, data entry, source document management, and monitoring overhead

Slower data timelines

Delays in transcription, query resolution, data cleaning

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Operational complexity

Coordinating multiple sites, maintaining consistency, ensuring training quality

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Scalability issues

Geographic expansion is expensive, patient recruitment may be limited by site reach

But modern technologies can help overcome many of these issues.

Role of Technology in Traditional Site‑Based Trials

To optimize site-based trials, sponsors and CROs increasingly adopt software and digital tools—without abandoning the advantages of in-person oversight:

EDC (electronic data capture): Replaces paper CRFs with digital forms for direct site input, real-time validation, and built-in logic checks
eCOA / ePRO: Even in site-based settings, patients can self-report questionnaires via mobile apps on-site or at home
eConsent: Digitally capture informed consent at the site to improve version control and compliance
Imaging, PACS & adjudication modules: Direct integration of imaging data collected on-site

Site monitoring tools & remote monitoring aids: Hybrid site monitoring, triggered remote reviews, dashboards

These tools help traditional trials inherit some of the efficiencies of decentralized trials while retaining control and oversight.

Benefits of Traditional Site‑Based Trials

Rigorous Clinical Control

Ensures standardized, high-fidelity measurements (labs, imaging, vital signs) under consistent settings.
Minimizes variability due to remote data collection factors (patient self-administration, device heterogeneity).

Direct Monitoring and Oversight

Enables in-person monitoring, site visits, and on-site audits to maintain data integrity.
Facilitates immediate verification of protocol procedures and investigator compliance.

Regulatory Predictability

Many regulatory authorities are more comfortable with rich source data from in‑person visits.
Pathways and documentation requirements are well established for site-based trials.

Patient Safety and Clinical Care

Patients can be physically evaluated, managed, and intervened upon immediately if needed.
Physical site presence supports diagnostic procedures, imaging, or sample collection that cannot be reliably done remotely.

Why Use TrialKit for Site‑Based Trials?

TrialKit isn’t just for decentralized trials. It excels in site-based settings as a comprehensive digital backbone:

– Unified platform combining EDC, ePRO/eCOA, eConsent, imaging, and AI analytics
– Seamless monitoring and query resolution in real-time
– In-built audit trails, versioning, and compliance features to support regulatory review
– Intuitive interfaces for site staff to minimize training burden
– Scalability for multi-site or global trials
– Integration support for labs, imaging systems, and external vendors

By centralizing operations and data, TrialKit helps sites focus less on administrative overhead and more on quality execution and patient care.

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FAQs About Traditional Site‑Based Trials

Are site-based trials obsolete with decentralized models rising?

Not at all. For procedures requiring in-person assessments, imaging, sample collection, and specialized equipment, traditional trials remain essential. Hybrid models can complement but often can’t fully replace site-based trials.

Can decentralized trials fully replace traditional studies?

Not always. Some trials still require in-person assessments or highly controlled environments. However, hybrid trials—which blend remote and in-person components—offer a flexible path forward and are becoming increasingly common.

How does EDC software improve site-based trials?

EDC for clinical trials enables direct digital entry at the site, reduces transcription error, accelerates query resolution, and lets sponsors access data as it’s collected, improving speed and data quality.

Can TrialKit support purely site-based trials?

Yes. TrialKit supports fully site-based trials with all the necessary modules (EDC, eConsent, site monitoring, imaging, audit trails, and more) without requiring deployment of decentralized features.

How do you manage site diversity and standardization?

TrialKit allows customizable workflows, consistent protocol templates, version control, and comprehensive training and support to ensure consistency across heterogeneous sites.