Good Clinical Practices
Global Experts in Clinical Trials for Real-World Medical Breakthroughs.
Global Experts in Clinical Trials for Real-World Medical Breakthroughs.
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.
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.
The European Union’s Good Manufacturing Practice (GMP) standards, as outlined in the Annex to the Guide to Good Manufacturing Practice for Medicinal Products, ensure the quality and safety of medicinal products, including those used in clinical trials. The Qualified Person (QP) plays a crucial role in batch certification, particularly for
In the intricate process of developing new pharmaceuticals, guaranteeing product safety, effectiveness, and adherence to global regulations is essential. Batch release testing acts as a pivotal quality assurance measure, confirming that medications comply with rigorous criteria before distribution. When combined with International Council for Harmonisation (ICH) standards, this testing framework
In the world of life sciences, quality isn’t just a benchmark—it’s the backbone of success. Three key pillars—Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP)—form the core framework that supports everything from product development to regulatory approval. These standards aren’t just industry buzzwords; they’re the
In the pharmaceutical industry, quality is paramount—and at Zenovel, we are deeply committed to delivering excellence in Quality Assurance (QA). Our focus is on ensuring that every medicine is developed, manufactured, and delivered with safety and reliability as top priorities. QA is embedded in every stage of the pharmaceutical lifecycle—from
The U.S. Food and Drug Administration (FDA) emphasize the importance of data integrity in pharmaceutical manufacturing, particularly under its Current Good Manufacturing Practices (CGMP) rules. However, issues like fake lab results and sloppy record-keeping persist, posing risks to patients and losing confidence in the system. Independent oversight is crucial to
In the rapidly evolving pharmaceutical industry, assuring product quality and customer safety is a need. This endeavour continues to be based on validation, a methodical procedure to verify that manufacturing procedures and equipment consistently deliver high-quality outcomes. A strong strategy to validation is required in 2025 due to the complexity
