Method Directory

Lorem ipsum dolor sit amet consectetur. Vulputate sed scelerisque sed et. Scelerisque id senectus dignissim tellus ac volutpat.

welcome to zenovel

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.

The basic purposes of clinical trial monitoring

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

We Helped by This Service

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.

0 +

Clients Retention

0 %

Cost decresed

Increased Sales

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.

Zenovel Gcp Services Packages

Pre Trial services	Services	ZenSight	ZenSure	ZenLife
During Trial Services	Periodic Monitoring
	MediMonitoring Service
	Quality Assurances Visit
	Investigation Visit
	PK-State Data Review

An Essential Requirement Of Risk-based Monitoring Plan

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

How We Research

Lorem ipsum dolor sit amet consectetur. Vulputate sed scelerisque sed et. Scelerisqu

Research

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

Experiment

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

Apply

Good Manufacturing Practice (GMP) audits are there to ensure that products are made in accordance with quality standards and industry best practices.

Other Services

We are happy to help.

Other services for Method Directory

Lorem ipsum dolor sit amet consectetur. Vulputate sed scelerisque sed et. Scelerisque id senectus dignissim tellus ac volutpat. A pulvinar placerat nibh ut feugiat. Eget nascetur iaculis adipiscing.

Monitoring

Efficient Clinical Research Monitoring is critical for protecting the well-being of trial participants and maintaining the integrity of final results.

PK Stat

Zenovel offers complete support in PK stat which starts from Study Design finalisation to final review of PK stat report/SAS Out put.

Project Management

Project Management involve end to end services which start from Site Identification, Feasibility, Audit and Selection through budget finalisation, Protocol Review, Complete coordination and Monitoring of Study from Start to end till Final Close out and report submission.

GCP

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

GCP

GMP

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

RA Services

AI-powered Regulatory Affairs Services

Pre Submission Service

Dossiers Related Services

Submission Services

Post Submission Services

Batch Release & Testing Services

Support & Staffing Services

Regulatory Staffing Services

Other Services

RA Services

AI-powered Regulatory Affairs Services

Drug Dev. & Discovery

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

Key Expert Services

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