Welcome to our comprehensive suite of services designed to ensure the pre-inspection
readiness of CROs/sites in the field of clinical research. At Zenovel, we understand the
critical importance of being prepared for regulatory inspections to maintain regulatory
compliance and data integrity. That’s why we offer a range of tailored solutions to help you navigate the complex landscape of regulatory inspections with ease.
Why Pre-Inspection Readiness Matters:
Pre-inspection readiness is about ensuring that CRO/Site is well-prepared to face regulatory
inspection at any given time. By conducting mock inspections, we assess your site or CRO's
preparedness and train your employees to handle real regulatory inspections confidently. This
proactive approach not only minimizes the risk of non-compliance but also fosters a culture
of quality and compliance at CRO/Site.
When to Plan:
Our services are designed to be deployed at various stage of clinical study:
Pre-Inspection Audit:
Zenovel can support in conducting Mock Inspection
before any regulatory inspection is announced for CRO/Site facility or a specific
study. Our mock inspections provide invaluable insights into your readiness and
identify areas for improvement.
During Inspection Support:
Zenovel provides on-site support during regulatory
inspections to ensure compliance and facilitate a smooth inspection process. Our
support includes training and documentation, guiding staff in communication and
coordination with regulatory inspectors, and resolving any issues that may arise
during inspection.
Post-Inspection Support:
After the regulatory inspection and upon receipt of the
inspection report, we assist your site or CRO in preparing responses and
implementing Corrective and Preventive Actions (CAPAs) to address any
findings.
Scope of Services:
Our comprehensive suite of services includes:
Inspection Readiness Training:
Train CRO/Site team with the knowledge and skills
needed to navigate regulatory inspections confidently.
Document Correspondence:
Ensuring that all necessary documentation is in order
and readily accessible for inspection.
Communication and Coordination:
Guiding CRO/Ste staff in effective
communication and coordination with regulatory inspectors.
On-Site Support:
Providing hands-on support during regulatory inspections to
address any issues in real-time.
Query Resolution:
Assisting in resolving any queries raised by regulatory inspectors
during the inspection process.
Inspection Follow-Up:
Supporting your organization in implementing any necessary
corrective actions following the inspection.
CAPA Preparation:
Assisting in the preparation and implementation of Corrective
and Preventive Actions to address inspection findings.
Regulatory Liaising:
Serving as a liaison between CRO/Site and regulatory agencies
to ensure compliance and facilitate communication.
Benefits to Sponsors:
Data Integrity Assurance:
Mock inspections ensure study data integrity, reducing
the risk of issues during regulatory inspections.
Risk Mitigation:
Identifying compliance gaps early helps mitigate risks, ensuring
studies adhere to regulatory requirements.
Enhanced Confidence:
Sponsors gain confidence in CROs and sites' commitment to
quality and compliance.
Mock inspections foster collaboration between sponsors,
CROs, and sites in addressing compliance issues efficiently.
At Zenovel, we are committed to helping you achieve and maintain regulatory compliance,
thereby safeguarding the integrity of clinical research data. Mock inspections play a crucial
role in ensuring data integrity, mitigating risks, enhancing sponsor confidence, streamlining
regulatory inspections, and facilitating collaboration between sponsors, CROs, and clinical
trial sites. By investing in pre-inspection readiness activities, sponsors can contribute to the
overall success and integrity of clinical trials.
