Project Management
Drive Efficient and Successful GCP-Compliant Trials with Our Expert Project Management, from Start to Finish
Drive Efficient and Successful GCP-Compliant Trials with Our Expert Project Management, from Start to Finish
Zenovel is committed to providing pharmaceutical quality control companies unparalleled support through our broad spectrum of project management services.
Sponsor of the study is ethically responsible for the safe conduct of the trial, even though the trial or study is currently being outsourced to CRO for additional technical support. To fulfil these responsibilities, all stakeholders must remain actively engaged in constant interaction and association with CRO. Zenovel acknowledges this primary obligation from the sponsors / client and pledges that all administrative and technical activities will be conducted by the CRO in accordance with the statement of work and GCP standards from the outset.
Zenovel’s project management services cover every aspect of clinical trial management ensuring comprehensive support from start to finish which includes Site Identification, Feasibility, Audit and Selection through budget finalisation, Protocol Review, Complete coordination and Monitoring of Study and for Report submission.
Clinical trials are crucial for drug development, but managing them is complex due to the vast amount of data and patient safety concerns. Zenovel uses innovative approaches like Risk-Based Monitoring (RBM) to streamline processes, prioritize quality, and enhance trial efficiency. This blog explores RBM’s significance in clinical trials and how
In the dynamic, rapidly changing environment of the pharmaceutical industry, product quality and regulatory compliance is mandated. Computer System Validation (CSV) is essential to that goal, since it demonstrates that computerized systems used in manufacturing, testing or managing data are reliable and compliant. This Zenovel guide gives an overview of
Pharmacokinetics (PK) is a key element of drug development, and describes how a drug interacts with the body by defining its absorption, distribution, metabolism and excretion (ADME). Knowing about PK is essential in drug development to establish the safety and efficacy of drugs (both new and generic). It is Zenovel’s
Over the past few decades, clinical trial monitoring has significantly changed from conventional on-site visits to remote and risk-based monitoring with technology. These developments revolutionized clinical trial conduct, with enhanced efficiency, cost reduction, and increased data quality. At Zenovel, we are leading the charge in excessing these innovations to optimize
The pharmaceutical industry is heavily regulated, and compliance with strict standards is crucial for operational excellence and avoiding penalties. To achieve regulatory readiness, pharmaceutical quality leaders use proactive preparation methods like mock inspections and compliance gap analysis. Zenovel guides companies through these processes to strengthen quality systems, enhance staff readiness,
Quality and compliance are paramount in the life sciences and pharmaceutical industry. Regulatory agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the World Health Organization (WHO) have established rigorous requirements that rely on a holistic approach to quality assurance (QA) and validation. At Zenovel,
