CLINICAL TRIALS
What is Pharmacovigilance for clinical trials and how to choose the service provider?
Good Clinical Practice (GCP) stands as a global benchmark for ethical and scientific quality in designing, documenting, and reporting studies involving human subjects. Adhering to this standard ensures the protection of the rights, safety, and well-being of study participants, along with the reliability of clinical data. Pharmacovigilance in clinical trials, outlined in these standards, serves as a crucial instrument for safeguarding of trial subjects.
The meticulous choice of a Pharmacovigilance service provider for clinical trials is paramount. The significance of having a team of highly qualified experts with extensive industry experience enables the effective and trustworthy management of aspects related to the safety of the involved patients and the studied medicines. Our objective is to enhance and modernize the various processes involved in overseeing clinical studies, ensuring strict adherence to the regulations governing this field.
VI.REL positions itself as a service provider capable of addressing the diverse needs of clients through tailor-made solutions. Leveraging the diverse expertise within our team, we guarantee comprehensive management of Pharmacovigilance activities in clinical trials, prioritizing both patient safety and regulatory compliance.
OUR SERVICES
Clinical Trial Pharmacovigilance
Pharmacovigilance Responsible Person (RP)
Our Pharmacovigilance Responsible Person (RP) service for clinical trials aids sponsors in monitoring the information within safety reports and facilitates access management to EudraVigilance. This ensures the thorough communication of all safety-related findings during the study to the European Medicines Agency (EMA). With our team of specialized experts, we commit to conducting a meticulous data analysis, ensuring compliance with regulatory standards, and maintaining efficient oversight of pharmacovigilance responsibilities throughout the entire clinical trial process.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Our services are pivotal in defining the safety profile of the experimental drug. Beyond documenting known adverse events as potential risks, our team is deeply committed to the meticulous collection, management, and accurate assessment of Serious Adverse Events (SAEs). We guarantee a thorough and prompt handling of information crucial to the well-being of participants in clinical trials.
Our comprehensive offering includes medical review and evaluation by highly qualified professionals. Our expert team diligently analyzes Serious Adverse Events, providing indispensable insights for managing reports on particularly significant adverse events that may arise during clinical studies. These activities are indispensable for a thorough evaluation of the impacts adverse events may have on the risk-benefit balance of the experimental product, thus contributing to ensuring the safety and efficacy of the treatment under study.
We collaborate seamlessly with the clinical study team to ensure precise communication with the ethics committee following local guidelines. This ensures the timely and appropriate notification of all SAEs, fostering a proactive and responsible approach to participant safety in clinical trials.
Suspected Unexpected Adverse Reactions (SUSARs)
The effective and timely management of suspected unexpected adverse reactions (SUSARs) during clinical trials requires a reliable service provider to ensure proper reporting to the competent authorities. Our comprehensive management of SUSARs is executed by a team of experts who handle all aspects of reporting with the utmost precision, including timelines for SUSAR notification and reporting formats
Development Safety Update Report (DSUR)
Medical oversight and Case narrative
We specialize in providing tailored services in drafting reports on adverse events observed in patients during clinical trials. These reports play a pivotal role in establishing a causal link between the drug and the observed events, thereby contributing significantly to the overall safety assessment of the product. Drawing on our extensive expertise, we ensure a thorough and lucid analysis of events, supporting the reporting and evaluation of adverse reactions.
Our services extend to offering dedicated support to the clinical study team, ensuring meticulous oversight of protocols and providing valuable medical insights in the management of adverse events. Our proficiency lies in the precise review of clinical data and critical parameters essential for the pharmacovigilance of the study, including the accurate coding of information related to adverse reactions following the guidelines of the Medical Dictionary for Regulatory Activities (MedDRA).
Safety Management Plan (SMP)
The Safety Management Plan (SMP) stands as a pivotal document in safeguarding patient well-being by identifying and effectively managing potential risks. It facilitates seamless communication and collaboration among diverse stakeholders involved in the study, ensuring alignment with regulatory standards set forth by the FDA and EMA. VI.REL offers comprehensive services for the meticulous drafting and revision of the SMP, encompassing all associated modules to ensure thorough compliance with reporting requirements related to the safety of experimental drugs.
Clinical Study Report (CSR)
We offer comprehensive services for the creation and management of the Clinical Study Report (CSR). This document seamlessly integrates clinical and statistical descriptions, presentations, and analyses into a unified report. It includes essential appendices such as the study protocol and comprehensive information regarding the drugs and patients involved in the study. Our team of specialists guarantees the meticulous preparation of the CSR, ensuring full compliance with current regulatory standards.
Reference Safety Information (RSI)
VI.REL provides comprehensive management services for Reference Safety Information (RSI) related to investigational medicinal products (IMPs) in clinical trials. Our team meticulously evaluates each Suspected Unexpected Serious Adverse Reaction (SUSAR) and meticulously drafts the RSI, adhering to the coding standards of the Medical Dictionary for Regulatory Activities (MedDRA). This ensures accurate document handling and secures the safety of study participants in full compliance with regulatory standards.
Clinical Trial Application (CTA)
We offer comprehensive services encompassing the preparation and submission of clinical trial applications to relevant authorities. Our service involves the meticulous compilation of details regarding investigational drugs and the planned study, all under medical supervision. VI.REL team ensures a precise assessment of the experimental design, anticipating potential challenges, and ensuring strict adherence to current regulatory standards.
Risk/Benefit Ratio of the Investigational Medical Product (IMP)
Our service for evaluating the risk/benefit ratio of Investigational Medicinal Products (IMPs) centers on a comprehensive review of safety data. This risk-based analysis incorporates the distinct safety profile of the IMP, therapeutic indications, and previously identified risks. By gaining a profound understanding of the investigational medicinal product, we can assess potential risks relative to the established standards of care for the relevant clinical condition. This ensures a thorough and precise evaluation of the risk/benefit balance.
