Good Clinical Practices

Global Experts in Clinical Trials for Real-World Medical Breakthroughs.

We specialize in conducting clinical trials globally to evaluate the effectiveness of novel medical intervention in real life clinical settings.

We provide all inclusive GCP services to ensure clinical trials meet ethical, regulatory and scientific standards, covering planning, execution, monitoring, and reporting at every stage of clinical studies.

We are top GxP service provider organization with over 20 years of experience, offers services Globally. Zenovel is an emerging global leader, focusing to provide one stop solution to pharmaceutical industry to help safe and effective medicine come in market with expertise in clinical research.

Audit
Risk Based Monitoring
Pre-inspection Readiness
Project Management
Sponsor Oversight
QMS Setup
PK Stat Review
CRO Setup / Upgradation
CSV
Training
Contract Staffing

1. Audit

Have partner with Zenovel to ensure the highest standards of integrity, quality, and compliance in your clinical studies for GCP audit requirements

Our team of knowledgeable auditors offers GCP audit services to ensure clinical trials meet the highest ethical, regulatory and scientific standards, ensuring compliance with international guidelines as well as local regulatory requirements, protecting the integrity and credibility of the research.

2. Risk Based Monitoring

We ensure your clinical trial excellence through our proactive risk management.

We offers advanced Risk-Based Monitoring (RBM) services for clinical studies (BA/BE, Clinical trials, PK studies), focusing on detecting, evaluating, and minimizing risks to ensure patient safety, data integrity, and regulatory compliance, while reducing operational costs.

3. Pre-Inspection Readiness

We ensure cliinical trial sites are inspection ready with pre-inspection readiness services.

We, at Zenovel provide comprehensive pre-inspection readiness services for clinical studies/CRO/Sites, ensuring compliance with GCP standards. Our team conducts mock inspections, reviews study documentation, provides staff training, and optimizes facility preparation.

We offer customized compliance checklists and post-inspection support to mitigate risks and maintain on-going compliance.

4. Project Management

We offer customized project management services for clinical studies, ensuring regulatory and GCP compliance and positive results.

We offer project management services for clinical studies, ensuring efficient execution and regulatory and GCP compliance. Our experienced team manages trial planning, vendor management, risk mitigation, and data integrity, ensuring successful outcomes and patient safety throughout the project lifecycle.

5. Sponsor oversight

We believe in fostering performance with extensive sponsor oversight for assuring successful trial acquisition.

We provide sponsor oversight services for clinical trials, ensuring efficient execution and regulatory and GCP compliance. Our team collaborates with sponsors and take all delegated responsibility on behalf of sponsor to plan trials, manage vendors, and maintain data integrity, and also prioritize risk management, site oversight, and data integrity, ensuring successful trial outcomes.

6. QMS Setup

We emphasize the importance of integrating quality in every step through competent QMS configuration for GCP compliance.

Zenovel focuses on establishing strong Quality Management System (QMS) as per the GCP and Regulatory standard. We offer services like SOP and policy development, document management, training, quality control tasks, and many others ensuring high-quality and compliant trial conduct through a continuous development process.

7. PK Stat Review

We give a complete guide on professional PK statistical analysis, emphasizing the importance of understanding it for informed decision-making.

We provide expert pharmacokinetic statistics evaluation services, ensuring in-depth data interpretation and analysis in clinical studies. Our statisticians evaluate concentration-time profiles, PK parameters, and apply relevant statistical procedures to extract useful information about drug exposure and pharmacokinetics, along with provide simple statistical reports for regulatory filings and decision-making.

8. CRO Setup / Upgradation

We enhance your CRO operations with skilled GCP Compliance setup and upgrades.

We offer comprehensive CRO setup and upgradation services as per the GCP and Regulatory standard, including system development, vendor management, process optimization, QMS implementation, and facility development as per the regulatory and GCP compliance. Our customized strategy for CRO setup/upgradation, ensuring effective clinical trial management, improving output, calibre, and compliance with regulations. Partner with Zenovel for professional assistance in building and refining your CRO.

9. CSV

We offer an expert CSV for GCP-compliant Clinical Studies, ensuring data integrity.

10. Training

We focus on the importance of expert training on various GCP operations in enhancing the excellence of clinical research.

Zenovel offers comprehensive training ensuring adherence to GCP, regulatory guidelines and protocol compliance. It enhances trial quality, mitigates risks, and ensures regulatory compliance.

11. Contract Staffing

We offer flexible GCP staffing solution for seamless clinical trial.

Zenovel provides contractual recruiting for global CROs and pharmaceutical firms, offering Full-Time Equivalent (FTE) models with experienced CRAs and Auditors from over 30 countries, ensuring high standards of quality and compliance. Our experienced staffs include CRA, CTA, CRC, Project Manager, Data Manager, Medical & Scientific Writer, allowing for efficient management of trial workload and timelines.

Reach out to us for any inquiries or support needs.

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

We provide affordable, innovative, and high-quality solutions to pharma industry with ethics driven research and increasing accessibility to high quality medicine worldwide

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

GCP

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

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

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

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

Good Clinical Practices

We specialize in conducting clinical trials globally to evaluate the effectiveness of novel medical intervention in real life clinical settings.

1. Audit

Have partner with Zenovel to ensure the highest standards of integrity, quality, and compliance in your clinical studies for GCP audit requirements

2. Risk Based Monitoring

We ensure your clinical trial excellence through our proactive risk management.

3. Pre-Inspection Readiness

We ensure cliinical trial sites are inspection ready with pre-inspection readiness services.

4. Project Management

We offer customized project management services for clinical studies, ensuring regulatory and GCP compliance and positive results.

5. Sponsor oversight

We believe in fostering performance with extensive sponsor oversight for assuring successful trial acquisition.

6. QMS Setup

We emphasize the importance of integrating quality in every step through competent QMS configuration for GCP compliance.

7. PK Stat Review

We give a complete guide on professional PK statistical analysis, emphasizing the importance of understanding it for informed decision-making.

8. CRO Setup / Upgradation

We enhance your CRO operations with skilled GCP Compliance setup and upgrades.

9. CSV

We offer an expert CSV for GCP-compliant Clinical Studies, ensuring data integrity.

10. Training

We focus on the importance of expert training on various GCP operations in enhancing the excellence of clinical research.

11. Contract Staffing

We offer flexible GCP staffing solution for seamless clinical trial.

Blogs and news

Our Latest Article

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