Risk Based Monitoring Approach

Efficient Clinical Research Monitoring is critical for protecting the well-being of trial participants and maintaining the integrity of final results. It is now globally accepted that the process for clinical trial monitoring needs to be changed from the conventional approach to Risk-based Monitoring in Clinical trials. The risk-Based Monitoring Approach is now the preferred method for monitoring clinical trials and Bioequivalence Studies.

Initially, FDA has introduced the concept of monitoring in clinical research to oversee the compliance and integrity of overall trial conduct. However, ICH has taken this to a very advanced level by introducing the Risk-Based Monitoring Approach during Clinical Trial/Clinical Research including Bioequivalence Studies and all kinds of studies involving human participants.

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The Risk-Based Monitoring Approach specifically focuses more on the areas where there is a higher chance of error and which may lead to failure of the trial, compromise of safety and waste of resources.
Later on, EMA also published the reflection paper and supported the Risk-Based Approach during monitoring as a very essential tool to enhance the quality of conduct of the trial.

Advantage of RBM includes lower cost, fewer errors, better analysis, cross-site comparison, more timely result, improving patient safety and data quality and complying with regulatory requirements, which make RBM very essential nowadays.

With a highly experienced team, Zenovel is the most trusted and credible partner for many Pharmaceutical companies for overseeing the clinical trials and bioequivalence studies with an effective, focused and well planned Risked Based Approach of Monitoring. 

The Basic Purposes of Clinical Trial Monitoring:

Clinical Research Monitoring / Clinical Trial Monitoring is performed to verify,

  • The rights and well-being of human subjects are protected.
  • The reported trial data are accurate, complete, and verifiable from source documents.
  • The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with the applicable regulatory requirement(s).

An Essential Requirement of Risk-Based Monitoring Plan

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Monitoring plan is the key document to be prepared specific to the trail and molecule. Monitoring plan will be covering the identification and selection of the monitor, training and delegation of monitors based on the experience, qualifications, scientific and/or clinical knowledge needed to monitor the Clinical Trial or Bioequivalence Study.

Monitor should be familiar with the investigational product(s), the protocol, written informed consent form and any other written information to be provided to subjects, the sponsor’s SOPs, GCP, and the applicable regulatory requirement(s).

Monitoring plan should also cover a list of key risks identified and the strategies on how to mitigate the same while monitoring.

Zenovel has a well-established SOP for Risk-Based Monitoring Approach to ensure the maximum compliance and integrity of the data during the conduct of Clinical Trial or Bioequivalence study.

Details of Clinical Trial Monitoring Services / Clinical Research Monitoring Service and Scope:

Zenovel provides multiple tailor-made service packages which can be customized based on the study-specific requirements, study design, Risk Involved and based on the needs of clients. We always focus on the real requirement and all our efforts are inclined towards giving multiple choices to our clients to make it cost-effective yet quality-oriented.

Zenovel GCP Services Packages

Pre Trial services
During Trial services
Post Trial services

From which sponsor can opt for their choice of the package (ZenSight, Zensure, Zenlife), to achieve their desired goal and end results.    

Services ZenSight ZenSure ZenLife
Pre-Trial Service CRO/ PI Selection √ √ √
Feasibility √ √ √
CRO Audit and Qualification √ √
Protocol Preparation Support √
Protocol Review √ √ √
Method Development and Validation Verification √
Pre-Approval Support √
Investigator Meeting √
During Trial Services Periodic Monitoring √ √ √
Medico Monitoring Service √
Quality Assurances Visit √
For-Cause Investigation Visit √
PK-State Data Review √ √
Post Trial Services Retrospective Clinical Data Review √
Retrospective BA Data Review √
IMP Verification and Reconciliation √ √ √
Stand Alone Services Readiness Audit √ √
Project Management Services √
SOP/Documents Review
Control Correspondence
Training on Medical Devise i.e., Inhaler
Sponsor Oversight
Bio viewer and other Regulatory Query responding
Monitoring of Bioequivalence Studies includes the below-mentioned visits:
  • 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)
  • Pre study Method Development and Validation (MD/MV).
  • Pharmacokinetic and statistical Monitoring
  • Pharmacokinetic parameter estimation
  • Statically analysis Monitoring
  • Report review
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Patient-based Study may include the following types of visits,

  • Investigator Meet/kick-off Meeting
  • First Patient First Visit,
  • Last patient last visit
  • Site close out visit

Quality Assurance Verification Visit in Patient Based Trials/PK Studies.

  • First Patient First Visit
  • Second visit per 5/10 patient recruitment
  • Before Data base is locked

We are happy to help. Reach us at: +91-635-635-3636 , [email protected]

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