Project Management

Drive Efficient and Successful GCP-Compliant Trials with Our Expert Project Management, from Start to Finish

We are all-inclusive partner in excellence for End –to-End Clinical Trial Support

Zenovel is committed to providing pharmaceutical 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.

We offer range of services depending upon the phase of your trial

Site/CRO Identification
Feasibility
Audit
Selection and Study Budget Finalisation
Protocol writing and review
Selection of appropriate design of the study,
Regulatory insight,
Controlled correspondence with regulatory
Complete Pre-Approval support

Complete Coordination with CRO/Site personnel.
Timeline Management and Slotting,
IMP Accountability verification,
Complete Project Management of entire trial,
Complete Monitoring with Scope agreed upon with Client.
Risk-Mitigation plan assessment.

Retrospective Data review and Verification,
Independent QA visits
Report review
Close out
Pre-Inspection Readiness support,
Handling of Regulatory queries

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

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

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

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

Project Management

We are all-inclusive partner in excellence for End –to-End Clinical Trial Support

We offer range of services depending upon the phase of your trial

Blogs and news

Our Latest Article

FDA’s Approach to Nitrosamine Control: Innovative Solutions for Drug Safety and Compliance

In-Process Monitoring for BA/BE Studies: A Focus on DDIs

Revolutionizing Clinical Trial Monitoring: The Power of Risk-Based Monitoring (RBM)

Mastering Inhalation Studies: A Closer Look at Challenges and Solutions

Ensuring Data Integrity: Best Practices and Considerations

Enhancing Clinical Studies with GCP Audit and Monitoring

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