CRO Setup & upgradation old

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.

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Let’s explore how Zenovel plan CRO setup

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.

CRO Upgradation

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.

Opening meeting
Interview with key study team
Document review and data verification as per the protocol
Regulatory and GCP compliance assessment
Discussion on findings/observations
Conclusion meeting

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 the most 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
Establishing efficient 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

Contact us to learn about our experience and expertise on CRO’s setup and upgradation. Zenovel is dedicated to providing customized solutions that cater to your specific requirements and contribute to the success of your clinical research endeavors.

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

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