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RISK BASED MONITORING APPROACH

Clinical trial studies entail several complex elements that must be firmly monitored to guarantee the participant safety, uphold study protocol, and comply with regulatory requirements.

Efficient monitoring is essential in the clinical trial for safeguarding the well-being of the trial participants and ensuring the integrity of high-quality studies. Sponsors must bear the responsibility of overseeing trials to uphold the rights, welfare and safety of human subjects as well as the reliability of the trial relevant data.

Regulatory agencies like FDA and EMA mandate sponsors to monitor clinical investigations, encouraging them to develop risk-based monitoring plans that manage human subject risks and data quality. This approach focuses on preventing or managing significant risks to data integrity, human subject protection, and trial credibility, leveraging modern clinical trial methodologies.

FDA and EMA defined risk-based monitoring (RBM) as a crucial part of clinical trial management strategies, that involves a blend of centralized and on-site procedures to ensure human subject welfare and trial ethics. RBM aims to identify, assess, manage, communicate, and review risks throughout the trial's duration, ensuring safety, and integrity, protection of subjects' rights, data quality, and trial credibility.

Zenovel Services

Clients need monitoring services to ensure high quality standards across the clinical trials that they are in adherence with regulatory recommendation. We, Zenovel are able to assist by providing expertise and global resources necessary for effective monitoring We, Zenovel offer multiple customized service packages tailored to meet specific requirements of each study, considering factors like design, risks, and client preferences. We prioritize understanding clients' needs and aim to provide a balance between cost- effectiveness and quality assurance, ensuring a comprehensive solution for each study.

For Risk-Based Monitoring on studies involving healthy participants (Bioequivalence Studies/Phase-I), we assist in following process

Site Initiation Visit
In process periodic Monitoring for check-in, dosing, housing
Retrospective monitoring visits
Site Close out Visit
In process Bioanalytical Monitoring (IPBM)
Retrospective Bioanalytical Monitoring (RTBM)
Method Development and Validation Assessment (MD/MV)
Pharmacokinetic and statistical Monitoring
Study Report review

For Risk-Based Monitoring on patient based studies (Phase-II/III/IV), we assist in listed process

Site Feasibility Visit
Site Selection Visit /Site Qualification Visit
Site initiation Visit
Interim monitoring Visit
Quality Assurance Visit
Safety Monitoring
Site Close Out Visit

Zenovel’s Risk Based Monitoring Approach: Based on EMA Guidance:

Our expertise

Our skilled monitors evaluate your procedures and develop the best strategy tailored to your specific needs, often employing one or more of the RBM tactics outlined below.

Step 1

Risk assessment : Identifying potential risksand their impact on data quality and patient safety is crucial in RBM Involves analyzing protocol complexity, site performance metrics, and regulatory requirements

Step 2

Risk Control : Risk Mitigation / Risk Assessment Quality Tolerance Limit

Step 3

Risk Review & Reporting : Risk Review cycle Reporting quality

Step 4

Centralized monitoring : Uing advanced analytics and data visualization techniques to continuously assess trial data for anomalies, trends, and potential risks Monitor multiple site and study data in real-time

Step 5

Quality Threshold Limits : Helps in corrective action needed for data quality in clinical trials Conduction of regular site visits, audits, and review of trial documents

Step 6

On-site Monitoring : Conducted on high risk activities, protocol deviation, and site performance issues Ensures that potential risk are addressed

Zenovel offers comprehensive support for your next clinical trial, maximizing the potential of risk-based monitoring. With our site services, we provide a complete range of services, from protocol development to data dissemination. Experience a more efficient and patient-centric trial journey with us.

To discover how we can expedite your clinical trial process from start to finish, SCHEDULE A CONSULTATION with our team today

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Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance

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