Pharmacovigilance
Encompassing the Full life Cycle of Pharmacovigilance Services.
With decades of expertise, YOUV ensures the safety and efficacy of your products through tailored pharmacovigilance services. From development to post-marketing, we are your trusted partner for compliance, safety, and regulatory success.
Our Services:
We provide extensive pharmacovigilance and safety monitoring services, ranging from early development assistance to post-approval efforts. Our team of medical professionals possess in-depth expertise and hands-on understanding of regulatory mandates.
Our case processing team can augment your existing team, adhering to your standard operating procedures to accommodate changes in case volume. Our specialists are proficient in handling cases ranging from clinical trials to post-marketing sources, literature, and observational studies. Our top priority is to maintain the quality of data entered into the safety database to ensure consistent and internationally compliant processing of your safety data set.
- Case book-in & Triage
- Data Entry
- Narrative Writing
- Quality Review
- Medical Review
- Case Submission
We provide assistance in tracking the progression of a company’s products and securing their benefit/risk profile through regular safety reports and risk management plans. This ensures that patients worldwide receive safe and effective medications. Our specialists have a comprehensive understanding of both the technical and regulatory aspects and can help you prepare essential safety documents that are scientifically grounded and proportionate to the risk, optimizing the sustained safe use of medicinal products.
- Periodic Safety Update Reports (PSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Periodic Adverse Drug Experience Report (PADER)
- Annual Summary Report (ASR)
- Development Safety Update Report (DSUR)
- ACO reports – Addendum to clinical overview
At YouV, we understand the importance of comprehensive support during the closeout and post-closeout phases of your clinical research study. Our clinical data management team works closely with you to ensure that all necessary activities for study closeout and data archiving are performed efficiently and effectively.
- Conduct final data cleaning and data quality control activities.
- Prepare study database for archiving and maintenance.
- Provide final study datasets and analysis datasets.
- Generate final study reports and submit to sponsor.
- Assist with publication and presentation of results.
- Maintain study data and archives for long-term accessibility.
- Provide ongoing support for regulatory submissions and interactions with regulatory agencies.
Pharmacovigilance risk management aims to ensure the safe usage of drugs and protect patient health. It is a set of actions taken to identify risks, evaluate risks, and reduce and prevent risks.
- Risk management system development
- Identification of safety concerns
- Development and Implementation of risk minimization measures
- Assessment of risk minimization measures
- Preparation of RMP update(s) based on change in safety profile of product
As part of routine pharmacovigilance, the assessment of safety signals is crucial to enhancing patient safety and public health through improved adverse reaction detection, assessment, comprehension, and prevention. We ensure that your Safety Signals Management activities are comprehensive and that your actions are always timely, accurate, and compliant through our experienced team.
- Literature review
- Signal detection
- Signal validation
- Signal confirmation
- Signal analysis and prioritization
- Signal assessment
- Recommendation for action
The medical information (MI) call centre is an integral component of a comprehensive pharmacovigilance system, serving as a crucial source of adverse event and product quality information. Efficient operation of the MI call centre is vital, as an increasing volume of calls can cause the centre to become overwhelmed, resulting in team exhaustion, prolonged wait times, missed calls, and a decline in the overall quality of your pharmacovigilance system.
- Medical Inquiry
- Product quality complaints
- Adverse event reporting
- Query management
- Case follow up
Why Choose YOUV for Pharmacovigilance Services?
Customized Safety Solutions
We tailor our pharmacovigilance approach to align with your therapeutic focus and regulatory requirements, ensuring precise and effective drug safety management.
Proactive Risk Management
Our team identifies and mitigates potential safety risks early, safeguarding patient well-being and supporting regulatory compliance.
Global Regulatory Expertise
With deep knowledge of international guidelines, we ensure your pharmacovigilance operations meet global standards seamlessly.
Technology-Driven Efficiency
Our use of advanced tools ensures accurate, real-time safety data processing, enhancing efficiency and minimizing errors.
Our Expertise
Ensure Safety, Foster Trust.
Partner with us for comprehensive Pharmacovigilance services and safeguard patient well-being. Contact us today
