Good Clinical Practices (GCP)
Global Experts in Clinical Trials for Real-World Medical Breakthroughs.
Global Experts in Clinical Trials for Real-World Medical Breakthroughs.
We provide comprehensive GCP services to ensure that clinical trials meet the highest Good Clinical Practice standards—covering planning, execution, monitoring, and reporting at every stage of clinical studies.
With over 20 years of global experience as a trusted GxP service provider, Zenovel offers end-to-end support to the pharmaceutical industry, helping organizations maintain compliance, protect patient safety, and bring safe and effective medicines to market. As an emerging leader in clinical research solutions, we deliver a one-stop approach that combines expertise, reliability, and innovation.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Zenovel offers comprehensive training ensuring adherence to GCP, regulatory guidelines and protocol compliance. It enhances trial quality, mitigates risks, and ensures regulatory compliance.
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.
Risk-Based Monitoring (RBM) is a more efficient alternative to traditional clinical trials, focusing on high-risk areas through data-driven insights. It ensures patient safety, data integrity, and regulatory compliance while reducing costs and timelines. However, the success of RBM depends on the competency of monitors, who identify risks, analyze data, and
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