Risk Based Monitoring Approach
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.
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
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 GCP Services Packages
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.
|Pre-Trial Service||CRO/ PI Selection||√||√||√|
|CRO Audit and Qualification||√||√|
|Protocol Preparation Support||√|
|Method Development and Validation Verification||√|
|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||√|
|Training on Medical Devise i.e., Inhaler|
|Bio viewer and other Regulatory Query responding|
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
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