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“Zenovel, your trusted partner for Regulatory Compliance and Clinical Research Quality Assurance”
Prior outsourcing any Bioavailability/ Bioequivalence (BABE) study or clinical trialto a contract research organization (CRO), it is essential to assess CRO or vendor for compliance standards and quality of services.
Zenovel is the all-in-one solution, we offer clients with arrays of audit options supported by our dedicated and highly experienced teams of auditors. Our auditors have undergone numerous inspections by various regulatory bodies, which enhance our understandings of regulatory perspectives and reassure our clients during regulatory examination. To ensure adherence to Good Clinical Practice (GCP) in clinical trial process, we offer a comprehensive selection of audits services through our GCP consultancy division.
Based on Zenovel experience and clients specific requirements, we have segmented audits services as:
CRO Audit
CRO Site System and Facility audit for Qualification and Re-Qualification
Our team gauge the CRO's or site's competence for carrying out clinical trials and BA/BE studies in accordance with GCP standards and other specific regulatory requirements, our comprehensive 360-degree approach provides a clear image of the CRO/site's adherence to current GCP and GLP, as well as relevant legal and ethical norms. It is also a regulatory necessity to qualify the CRO/vendor with a thorough audit before outsourcing any trial or study to verify that the CRO/site has the systems and facilities that support clinical research/trials in conformity with GCP and regulatory standards.
Priorto assigning any BABE studies or clinical trial to a CRO. The CRO or vendor must be certified or trained to ensure a high degree of compliance and high-quality services.
Comprehensive review of the system and facility according to regulatory requirements, covering all departments such as clinical, bioanalytical, pharmacokinetics (PK), quality assurance (QA), IT, administration, human resources (HR), and vendors assessment of past inspection track records and experience Evaluation of all standard operating procedures (SOPs) and documentation Review of resource management and capabilities
Vendor Qualification Audit
At Zenovel, we meticulously conduct thorough quality assurance audits on CRO/sites to ensure their suppliers meet regulatory standards like GCP and NABL. These audits guarantee the integrity, dependability, and compliance of research services provided by suppliers in areas like pathology, radiology labs, archival facilities, IT, computer system validation, and pharmacy. The aim is to ensure all aspects of the clinical research process adhere to the highest standards of quality and regulatory compliance. By this method, clinical research projects are more successful and possess overall integrity.
Before outsourcing any research/study specific services to any vendor, it is required to qualify the vendor for compliance level and quality services.
Pathology and Radiology Laboratories: Oversee accreditation verification, regulatory adherence, operations, QMS process, equipment maintenance, calibrations, sample handling, data management, staff competency, and safety control measures.
Archival Facility: We assist in record keeping, handling and retrieval process, security process, access control, storage condition (Temperature and Humidity control), and disaster recovery plan.
IT and Computer System Validation (CSV):Our range of services included system and cyber security, data protection, data back and recovery, system and software validation and maintenance, regulatory compliance, gap assessment, data integrity.
Pharmacy:Our expert team helps in study drug handling process, storage department and condition, temperature and humidity control, equipment (laf, refrigerator, deep freezer, etc.), pharmacy sops, study drug dispensing and retention process, security and access control, sterilization process, line clearance process, etc.
CRO/Site GAP Audit
We assist to get an in-depth review with intention of uncovering gaps and potential areas for improvement in the procedures and operations of a Contract Research Organization (CRO) or clinical trial site.
GAP evaluation audit can be accomplished at various phases of clinical trial/study such as pre-study phase, prior to CRO/site selection, while in study performance, prior proceeding to regulatory inspection.
Zenovel helps in assessment of regulatory compliance, QMS, clinical and analytical operation, data management process, data integrity, training and assessment procedure, safety assessment process and reporting, etc.
Study Specific Audit
Pre-Inspection Readiness/ Mock Inspection/ Regulatory Compliance Audit
Zenovel provides support to plan facility regulatory inspection or for a particular specific study, ensuring the trustworthiness of the study data.
- Pre – inspection Audit: (Mock Inspection)
Prior to any regulatory inspection is announced for facility or specific study, and after the submission of the first study for a particular regulatory agency.
- During Inspection Support:
We offer clinical trial sites and CROs on-site aid for regulatory inspections to ensureadherence to protocols and efficient inspection procedures. This service includes assistance with training and paperwork, helping staff with coordination and communication with regulatory inspectors, and resolving any issues that arise.
For-Cause Investigation
Zenovel uses innovative and advanced root cause analysis technique to identify primary cause of problem or failure implementing corrective and preventive measures as a solution. This involves the tracing sequence of events leading up to the issue and creating a plan of action to address and prevent future setbacks.
Zenovel assist when unexpected results emerged in the research and it nearly failed, the study was compromised due to abnormal concentration being obtained,
Zenovel assist in examining high risk areas where errors are most likely to occur and identifying issues or mistakes that contributed to the failure. We conduct a full evaluation of the problems and errors using systematic root cause analysis techniques, and offers strategies to prevent future challenges thereby increasing productivity and profitability.
Investigator Site Audit
Zenovel’s purpose is to ensure regulatory compliance, data integrity, subject safety, quality assurance, and risk assessment of clinical trial activities and documents during or after the study's completion.
It is carried out while in the process of studies, after the completion of the studies, and followed by all cause audit
Here, review of informed consent process, eligibility assessment, source document, protocol, GCP, and regulatory compliance, safety assessment, IMP management, facility visit, staff competency assessment and training is needed for study compliance
Quality Assurance Audit
In order to ensure data integrity, subject safety, compliance assurance, risk assessment and management, quality improvement, and inspection readiness
Following the completion of the entire study we provide on-going monitoring associated research including after the completion of study's conclusion and conduct through for-cause investigation.
Review of informed consent process, eligibility assessment, source document, protocol, GCP, and regulatory compliance, safety assessment, IMP management, data management and record keeping, facility visit and equipment assessment, staff competency assessment and training.
Safety Assessment Audit
For the purpose of to assess participant safety, medical experts will also evaluate AE/SAE evaluation and follow-up, regulatory compliance, risk management, and ethical responsibility.
It is conducted prior to study, post dosing, during the study, after completion of the study, and for-cause visit.
Medical History and Baseline Assessment, AE/SAE recording and reporting, Assessment, management, and follow up of AE/SAE
Study Specific Approach
