Before outsourcing any BABE/Clinical Trial/Study in any Contract research organisation. It is required to qualify the CRO/vendor for compliance level and quality services.
Zenovel provides an opportunity to clients to choose a wide range of audits. We have a well experienced dedicated team of auditors. Our Auditors have faced many regulatory audits from different regulatory agencies and regulatory inspectors. We understand the perspective of a regulatory agency which helps our client to be more confident while facing regulatory inspection. We offer a wide range of audits in our GCP consulting Services vertical for specific reasons to focus on and ultimately ensuring GCP in Clinical Research.
To evaluate the capabilities of CRO/Site to conduct BA/BE study in compliance with GCP Standards and various specific regulatory requirements. Our detailed 360 Degree approach given a complete picture of CRO/Site with respect to compliance with current Good Clinical Practice and Good Laboratory Practice and applicable regulatory and ethical guidelines. This is also a regulatory requirement to qualify the CRO/Vendor with a detailed Audit before outsourcing any trial or study to ensure the GCP in Clinical Research/ Trials.
Before outsourcing any BABE/Clinical Trial/Study in any Contract research organisation. It is required to qualify the CRO/vendor for compliance level and quality services.
To select qualified Investigators or hospital sites for conducting clinical trials. Which is also known as “pre-study qualification visits” or “site visits” and to determine the investigative site’s ability to conduct the clinical study.
We also recommend verification of Site Qualification done by Trial CRO.
Generally, site qualification is performed before the commencement of the trial or phase study. It is also essential to requalify the site at a certain interval to assess their capability to conduct the trial.
Independent audit of a clinical trial is an important element of GCP in Clinical Research. Trial Audit is completely independent and separate from the monitoring, quality Assurance, quality control done by the CRO.
The whole purpose of Clinical Trial Audit is to evaluate the conduct and the level of compliance with the protocol, GCP, SOPs and the specific regulatory requirements. Mostly to,
Before conducting clinical project for specific regulatory and before submitting trail to specific regulatory.
A successful gap analysis identifies necessary changes in process, organization, and resources, and maps out a systematic approach for implementing solutions that effectively minimize risks to the organization.
When there is a need to upgrade the system to comply with recent regulatory requirements by filling gaps. To submit the study in another regulatory area then it was conducted for. Getting the system ready for new regulations for the first time. To upgrade SOPs and documentation by filling gaps.a
To evaluate Clinical & Bioanalytical facility/Pre-clinical facility/study data and to check compliance to trial protocols, Standard Operating Procedures, Good Clinical Practice (GCP in Clinical Research / Trials), Good Laboratory practices and the applicable regulatory requirements and risk Assessment.
Once the study is completed and CSR is ready, GCP/GLP audit is conducted to check its readiness for submission to respective regulatory authorities.
To identify the root cause of the problem or failure and to Implement solutions by corrective and preventive actions with use of advanced root cause analysis techniques. To trace the progression of events that led up to the incident. To design a way forward after failure.
When unexpected results were obtained for the study and failed by a margin. When abnormal concentration obtained which led to the failure of the study.
To get ready for the regulatory inspection on the facility or for a specific study. To gain the confidence of Study Data.
Before any regulatory inspection is announced for facility or specific study. After submission of the first study for a particular regulatory agency.
