CRO Setup & upgradation

Transform and Upgrades Your CRO with Our GCP Setup, and Custom Compliance Strategies

We encourage CRO’s through Setup and Upgradation

With extensive experience in auditing and monitoring CROs across more than 30 countries, Zenovel offers expert services for CRO setup and upgradation, leveraging industry knowledge and global insights to optimize partnerships, ensuring efficiency, compliance, and excellence in clinical research endeavours.

For Greenfield CRO setup, Zenovel implements holistic approach encompassing various essential elements to ensure efficiency, compliance, and integrity in clinical research.

By integrating these components, Zenovel ensure successful establishment and implementation of CRO setup with focus on client specific needs.

For the CRO upgradation initiative, Zenovel focuses on enhancing the capabilities of the existing facility to perform a wide range of clinical studies across all therapeutic areas, with the ultimate goal of achieving regulatory approvals for submission into major global markets such as USFDA, EMEA, MHRA, WHO, TGA, ANVISA, and others.

Implementing an Excellent Documentation System in Compliance with Global Standards

With our assistance in facility upgradation, CRO’s can possess following advantages:

Implementing an Excellent Documentation System in Compliance with Global Standards
Enhancing Quality Standards of operations and system to Meet Global Requirements
A Highly Efficient Quality Management System Incorporating themost contemporary global practices.
Adopting a Risk-Based Approach in Quality Management to Meet the Expectations of Major Regulatory Agencies like USFDA, EMEA, TGA.
Streamlined Operations Management from Screening to Check-Out.
For enhance Global Presence and attract global Clients.
Highly compliant IT system.
Establishing right platform to enable paperless system in future.
Error free system
Deviation free system

Developing a Highly Efficient Staff through Comprehensive Training on All Aspects of New SOPs and Systems
Efficient Planning and Execution of clinical studies
Capable of handling global regulatory inspection
Establishing efficient data management
Establishingefficient project management
Conduct Clinical Studies in highly efficient and cost-effective manner
Ensuring Compliant Archival Management
Documentation in Multiple Languages
Implementing Efficient Client Management to Retain Existing Clients and Attract New Business

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Blogs and news

Our Latest Article

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

Understanding Nitrosamine Impurities in Pharmaceuticals: Nitrosamines, particularly N-nitrosamines, are probable or possible human carcinogens. They can form during the synthesis of active pharmaceutical ingredients (APIs) or during the storage of finished drug products. FDA guidance emphasizes the need for risk assessment, mitigation strategies, and regulatory compliance to control nitrosamine levels.

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Introduction: In-process monitoring is a critical component of ensuring the quality and reliability of BA/BE studies, especially those involving drug-drug interactions (DDIs). For DDI studies, in-process monitoring is particularly crucial due to the complex nature of interactions, the need for precise data, and the potential impact on patient safety. Key

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Abstract For the past few years, regulatory bodies, industry advocacy groups, and private companies have been tackling the concept of incorporating risk into the design of clinical trials and customizing monitoring strategies based on those risks to achieve higher-quality outcomes. Regulatory guidance like ICH and FDA encourag sponsors to adopt

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Introduction In the realm of inhalation studies, achieving consistent compliance and accurate results is a considerable challenge due to the complexities associated with trial conduct. Zenovel, a third-party monitoring company, boasts extensive experience in monitoring inhalation studies. This article sheds light on Zenovel’s recent involvement in the monitoring of three

Ensuring Data Integrity: Best Practices and Considerations

Introduction There are multiple definitions of data integrity, yet the essence is the same. Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity is the maintenance of, and the assurance of the accuracy and consistency of data over its entire life-cycle and is a critical aspect

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring GCP guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a

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

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

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

CRO Setup & upgradation

We encourage CRO’s through Setup and Upgradation

For Greenfield CRO setup, Zenovel implements holistic approach encompassing various essential elements to ensure efficiency, compliance, and integrity in clinical research.

By integrating these components, Zenovel ensure successful establishment and implementation of CRO setup with focus on client specific needs.

Implementing an Excellent Documentation System in Compliance with Global Standards

With our assistance in facility upgradation, CRO’s can possess following advantages:

Blogs and news

Our Latest Article

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Ensuring Data Integrity: Best Practices and Considerations

Enhancing Clinical Studies with GCP Audit and Monitoring

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