Parexel’s approach to risk-based quality management (RBQM) is a holistic risk strategy rooted in Quality by Design principles, that relies on critical data to drive decision-making throughout clinical programs and trials. Accordingly, our clinical trial monitoring strategies are tailored to study protocol requirements, risk level, complexity as well as site and regional considerations.
Our clinical monitoring approach
Every clinical trial monitoring plan is fit-for-purpose, informed by upfront risk assessments, Critical-to-Quality (CTQ) study attributes, whose integrity is essential for participant safety, data reliability, and valid conclusions. Investigator site mix and regional considerations are core inputs for determining the balance of on-site, remote and centralized monitoring.
Site mix describes the combination of investigator sites by characteristics such as:
- Geography (e.g., US vs. EU vs. Asia)
- Site type (academic, private practice, community clinic)
- Experience and capacity (number of prior trials, staff expertise)
Regional data includes:
- Regulatory environment (FDA, EMA, MHRA requirements)
- Local operational practices (data entry systems, consent processes)
- Historical performance (data quality, adverse event reporting, recruitment rates)
- Infrastructure and logistics (travel, language, cultural factors)
The combination of these factors informs risks (such as regions with smaller, less experienced sites or stricter ethical review practices) that inform the clinical trial monitoring plan.
Translating into the clinical monitoring plan
The clinical trial monitoring plan is a risk based blueprint, often with a combination of monitoring methods:
- On site monitoring for high risk or complex sites/regions
- Remote monitoring for lower risk or high volume sites
- Centralized data monitoring that informs onsite and remote site monitoring activities
- Hybrid approaches with all three approaches used in balance
Parexel’s clinical monitoring approach help clients identify, capture and manage quality issues at the earliest stages of emergence, before potential risks escalate into liabilities.
Why sponsors choose Parexel for clinical trial monitoring
Global coverage
Parexel has established and continues to expand a global pool of clinical monitoring roles, including CRAs and Clinical Data Monitors (CDMs) with average experience of 5+ years. Positions are regionally aligned to match site time zones and local language requirements.
Communication and project management
Our monitors are ambassadors of the sponsor and Parexel. They represent both companies when interacting with investigational sites. Through open communication and training, the CRAs understand and communicate sponsors' requirements for the conduct of the study, deliverables, and timelines.
+
CRAs in North America
+
CRAs in Europe
+
CRAs in APAC
+
CRAs in Latin America
Technology and standards
Parexel uses industry leading technology platforms for critical trial activities:
- Veeva Vault Clinical clinical trial management system (CTMS) is a cloud-based application built specifically to help manage the growing complexity of trials and improve study efficiency
- eClinical Solutions elluminate integrates all trial data into a common review platform for faster, more efficient decision making
- CluePoints RBQM is an AI powered Risk Based Quality Management platform that provides centralized statistical data analysis for improved data quality, reduced operational burden and unified oversight across multiple systems
Frequently asked questions
Risk Based Quality Management (RBQM) is rooted in Quality by Design (QbD) principals while applying Risk Based Monitoring (RBM) control mechanisms. This systems-wide approach encourages cross functional engagement in a holistic and risk-based approach to clinical trial management and oversight.
An adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.
- Onsite monitoring requires in-country CRAs to visit clinics and ensure data quality and integrity. They conduct Source Document Review (SDR) to assess study conduct and Source Document Verification (SDV) to compare source data with case report forms. They also manage sites by addressing issues, training staff, and ensuring adherence to Good Clinical Practice (GCP) guidelines.
- Remote monitoring assumes conducting trial oversight without on-site visits that may include SDR and SDV dependent upon site technology and subject to regional regulations. CRAs maintain site compliance and management virtually, ensuring GCP compliance. This methodology may include remote monitoring performed from regional hubs in globally cost-effective locations.
- In-house monitoring employs remote professionals in centralized locations, such as regional hubs located in globally cost-effective locations. Clinical Data Monitors conduct eData reviews, generate queries, and perform remote monitoring visits (excluding SDR/V).
- CM enhances clinical trial oversight through data-driven techniques.
- CM includes data surveillance using Quality Tolerance Limits, Key Risk Indicators, and Data Quality Indicators/Operational Metrics. Centralized Statistical Monitoring supported by technology, such as the CluePoints Central Monitoring Platform, analyzes data trends and anomalies.
- These processes identify concerns not always evident in on-site monitoring, triggering data-driven site contacts or visits. CM is an essential element of Risk-Based Quality Management (RBQM) ensuring alignment with ICH GCP E6R3, as well as efficient allocation of monitoring resources to address critical issues promptly.