What is the difference between on-site and centralized monitoring?

On-site monitoring is a CRA physically at the site verifying source data, consent, IP accountability, and site processes. Centralized monitoring is remote, analytics-driven review of incoming data across all sites to spot trends and risk signals. Excel360 runs both, so each informs the other.

Does risk-based monitoring reduce SDV coverage?

It makes SDV targeted rather than exhaustive. Critical data such as consent, eligibility, primary endpoints, and SAEs receive full verification, while lower-risk data is monitored through centralized checks, concentrating effort where it matters most.

Can Excel360 take over monitoring of an ongoing study?

Yes. We perform a structured monitoring transfer: documentation review, site risk re-assessment, and a transition monitoring plan that maintains continuity without gaps in oversight.

Can you provide monitoring across multiple countries?

Yes. Through a combination of on-site CRA coverage plus centralized and remote monitoring, we support multi-site and multi-region studies while adhering to local regulatory and data-handling requirements.

How do you report monitoring outcomes to sponsors?

Through detailed visit reports, KRI dashboards, deviation logs, and periodic trial-health summaries: a transparent, inspection-ready record of oversight throughout the study.

Division 03

Full-Spectrum Clinical Trial Monitoring

Excel360·Clinical Trial Monitoring

Excel360 combines dedicated on-site CRA visits with centralized, risk-based oversight: a hybrid model that strengthens protocol compliance, protects subjects, and keeps every site inspection-ready from initiation to close-out.

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60% Reduction

In Monitoring Findings

ICH-GCPRBM

360-degree oversight, from site floor to data trend

Traditional monitoring sees what happens during a visit; centralized analytics see what happens between them. Excel360 integrates both: dedicated CRAs on the ground, and remote risk-based surveillance running continuously across your data.

Aligned with ICH-GCP risk-based principles, this hybrid framework catches issues earlier, improves site performance study-over-study, and keeps sites inspection-ready across every trial phase.

Continuous Visibility: Remote analytics between visits mean risks surface early, not at the next monitoring visit.
Risk-Based Focus: KRI-driven prioritization puts monitoring effort where patient safety and data integrity need it most.
Audit-Ready Trails: Every visit, finding, and follow-up documented to inspection standard as it happens.
Subject Safety First: Consent, eligibility, and safety events verified as the priorities they are, at every visit.
Data You Can Trust: Source verification and centralized checks that protect the integrity of your primary endpoints.
Flexible Delivery: On-site, remote, or fully hybrid monitoring, matched to your study's risk and geography.

What Excel360 delivers

A monitoring framework across on-site, remote, and centralized functions, giving one integrated view of trial health.

Source Data Verification and Review (SDV/SDR)
Investigational Product accountability review
Site Qualification, Initiation, Monitoring and Close-Out Visits (SQV/SIV/SMV/SCV)
Structured visit documentation and follow-up letters

How an Excel360 engagement runs

A monitoring lifecycle built on ICH-GCP risk-based principles: planned, executed, and continuously recalibrated.

01
Monitoring Plan Development
Risk assessment drives a tailored monitoring plan covering visit cadence, SDV strategy, and KRI framework.
02
Site Initiation
SIVs confirm site readiness, training, and delegation before first patient in.
03
Hybrid Monitoring Cadence
On-site visits and centralized review run in parallel, each informing the other.
04
Risk Signal Response
KRI breaches trigger targeted visits, retraining, or escalation before issues compound.
05
Close-Out & Reporting
COVs, final reconciliation, and complete monitoring documentation delivered audit-ready.

Why sponsors choose Excel360

Issues caught between visits: Centralized surveillance helps close the blind spot where many protocol deviations are born.
Monitoring effort that follows risk: Resources concentrate on high-risk sites and critical data, rather than spread thin by rote schedules.
Findings addressed at the source: Structured escalation and retraining are designed to reduce recurring site findings over the study.
One integrated trial-health view: Sponsors see on-site observations and remote analytics in a single coherent reporting stream.
Aligned with ICH E6(R3): A risk-based model built on the monitoring approach global regulators now expect.
Continuity when you switch mid-study: A structured monitoring transfer keeps oversight unbroken when we take over an ongoing trial.

Who We Serve

The organizations Excel360 supports

Pharmaceutical Companies
Biotechnology Companies
CROs
Medical Device Companies
Vaccine & Biosimilar Developers
Academic Research Organizations

Questions, answered

The essentials sponsors ask before engaging Excel360. For anything more specific, our team is one conversation away.

It combines traditional on-site CRA visits with continuous centralized data review. Remote analytics flag risk signals such as enrollment anomalies, query trends, and KRI breaches, which then direct where and when on-site effort is deployed. It's the model ICH E6(R3) explicitly encourages.