What we do
Monitoring and Auditing of Clinical Studies
The role of Saanvi Ethical Research is to bridge the gap for following best ethical practices for data integrity and transparency for the regulatory success of your organization.
To meet the regulatory expectations, the sponsors need to improve quality by developing systems with specific standards for each clinical trial process. The quality systems include personnel roles and responsibilities, training, policies and procedures, quality assurance and auditing, document management, record retention and reporting and corrective and preventive action. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of the trial subjects are protected. Traditionally the quality of a clinical trial conducted at the investigator site is assessed by sponsor audits and regulatory inspections.
The quality depends a lot on how the site conducts the study. In India the sites are on a learning curve of clinical research, needing in-depth training in regulatory requirements, ethics, consent process, and protocol compliance. The combination of monitoring and auditing in a clinical trial setting can have an additive impact on the overall quality of the clinical trial. To understand the differences between auditing and monitoring we need to define a few terms:
Quality Assurance (QA) is defined as “all those planned and systemic actions that are established to ensure that the trial is performed and data generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s).
Quality Control (QC) is defined as “the operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities are fulfilled”
Monitoring is defined as “the act of overseeing the progress of a clinical trial and ensuring that it is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), GCP and the applicable regulatory requirement(s)”
Audit is defined as “a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), GCP and the applicable regulatory requirement(s)”.
Monitoring is a quality control function where study conduct is routinely assessed on an on-going basis at every step of the trial whereas Auditing is a quality assurance function, which is an independent, top-down, systematic evaluation of the trial processes and quality control.
Monitoring + Auditing = Solid Assurance of Quality
Monitoring and auditing although are distinct functions, but together they complement each other to create an additive impact on the overall quality and integrity of a clinical trial.
Strategy for clinical and regulatory development of new drugs /vaccines along with review and preparation of regulatory submission to CDSCO for the conduct of clinical trials
Expertise in clinical and regulatory development of new drugs/vaccines is the hallmark for successful development of products. We have the required expertise having formulated, reviewed and contributed to the development of optimum clinical and regulatory development paths for new drugs and vaccines. We have strong proficiency in review of clinical and non-clinical data required for different phases of clinical trials. This includes review of all CT related documents. Our detailed review would help product gap analysis early on and minimise product failure at regulatory level. We also have expertise in the preparation/review of IND/NDA for New Drugs/vaccines.
We seek collaboration with academia, MSMEs, start-ups and industry so that we can contribute to successful product delivery.
Setting up of Clinical Study Units
Protocol Writing and Site Staff Training
All these functions require detailed knowledge of clinical research and operations with detailed knowledge of changing clinical and regulatory requirements, expertise and clarity in different aspects of GCP, GCLP, relevant regulatory guidelines and ethical standards. Vast experience in designing clinical protocols for BA/BE studies and different phases of clinical trials.
Preparing you for Regulatory Inspections
By performing mock audits prior to regulatory inspections, SER will prepare your site for what to expect in the event of regulatory inspection. This primes the study teams for the type of questions and requests that may be forthcoming. The site and sponsor each gain confidence and know what to expect, outstanding issues if any are resolved and required documents are checked for correctness and completeness. Potentially some minor administrative improvements if required can be put in place to help facilitate the actual regulatory inspection. SER will work with your team so that deficiencies are not identified too late when not much can be done to correct them. SER with its experience and expertise will make it a valuable experience for all study members.
Independent Ethics Committee
Independent Ethics Committee of Saanvi Ethical Research LLP has been established by dedicated, experienced clinical research and quality professionals. The IEC believes in working proactively with stakeholders to bring changes to develop an Ethical mindset. We have a standardized review process of proposals by IEC members (Study Assessment Forms). Well defined SOP driven process has been put in place for identification and analysis of study updates/ AE & SAE reports for protocol deviation/ violation and GCP non-compliance which in turn would help organizations that approach us for review and approval of their clinical studies.