Sponsor Oversight

Elevating your trials by Seamless Execution, Compliance, and Data Integrity with our Sponsor Oversight mechanism

Zenovel commitment to seamless sponsor oversight

The sponsor holds sole accountability for management and monitoring of clinical trials. Therefore, there should be systems in place to ensure that contracted or outsourced tasks are being closely monitored guaranteeing patient wellbeing and data integrity.

When Regulators come to inspect the Sponsor oversight system, they expect following system in place:

USFDA has recommended the “Guidance for Industry Oversight of Clinical Investigations – — A Risk-Based Approach to Monitoring”emphasizing the importance of effective monitoring to protect human subjects and ensure high-quality studies. Sponsors of clinical investigations involving human drugs are required to provide oversight to ensure the rights, welfare, and safety of subjects and the quality of clinical trial data submitted to the FDA.

As per ICH E6 R2, the sponsor may establish an independent data monitoring committee (IDMC) to assess the progress of a clinical trial, including safety data and critical efficacy endpoints. The IDMC should have written operating procedures and maintain records of meetings. The sponsor should ensure oversight of trial-related duties and functions carried out on its behalf, including those subcontracted to another party by the sponsor’s contracted CRO(s).

Zenovel provides array of services for seamless sponsor oversight:

Contracts and agreement

Adherence to GCP is crucial and should be prioritized over internal policies and procedures. The contract should address subcontracting and outline the sponsor’s oversight of additional subcontracting. However, key legislative requirements, such as reporting urgent safety measures and serious breaches, are often missing from contracts, potentially leading to non-compliance due to unclear roles and responsibilities.

is essential before using a vendor and can serve as a continuous assessment mechanism. This can involve reviewing the vendor's Quality Management System (QMS), standard operating procedures (SOPs), site visits, or audits. In cases of multiple vendors, a communication plan should be in place, outlining processes and procedures for each party to follow, especially in case of potential breaches.

are crucial in identifying and rectifying non-compliances in trials. Inspectors may ask sponsors why they continue using certain products and if any mitigation were implemented to prevent recurrence.

are crucial for tracking trial progress, as they help identify potential issues and provide guidance on how to resolve them. A serious breach occurred when a packaging issue was not rectified, leading to a fatal overdose of IMP.

Sponsors should demonstrate oversight by reviewing and approving documentation such as Monitoring Visit Reports, Data Management Plans, Statistical Analysis Plans, deviation logs, and audit trails. It is essential to clearly define which documents are required for review within the sponsor's QMS and what the review entails.

Clear documentation of co-monitoring visits, activities performed, and identified issues should be provided, along with an appropriate Corrective and Preventative Action Plan (CAPA).

The sponsor should be promptly notified of any issues, including potential serious breaches, through procedures that identify and escalate them to the sponsor within 7 days. This process starts as soon as anyone working on behalf of the sponsor, including vendors, identifies the issue.

Adherence to GCP is crucial and should be prioritized over internal policies and procedures. The contract should address subcontracting and outline the sponsor’s oversight of additional subcontracting. However, key legislative requirements, such as reporting urgent safety measures and serious breaches, are often missing from contracts, potentially leading to non- compliance due to unclear roles and responsibilities.

are crucial in identifying and rectifying non-compliances in trials. Inspectors may ask sponsors why they continue using certain products and if any mitigation were implemented to prevent recurrence.

Zenovel maintains the highest standards for safeguarding patients and ensuring data authenticity through comprehensive supervision procedures, guaranteeing efficient management and monitoring of clinical studies.

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

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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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Sponsor Oversight

Zenovel commitment to seamless sponsor oversight

When Regulators come to inspect the Sponsor oversight system, they expect following system in place:

Zenovel provides array of services for seamless sponsor oversight:

Contracts and agreement

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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