Pharmacovigilance
Encompassing the Full life Cycle of Pharmacovigilance Services.
Pharmacovigilance is a critical area for any sponsor involved in the development, manufacturing and distribution of medicines. Choosing the right partner for your pharmacovigilance services is essential for ensuring the safety and efficacy of your products, and for meeting regulatory requirements. YOUV has the experience, expertise and technology to support your pharmacovigilance needs and help you achieve your goals. So why not choose YouV as your trusted partner today.
Our Services.
YouV provides 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)
- Canada Annual Summary Report (CASR)
- Development Safety Update Report (DSUR)
- ACO reports – Addendum to clinical overview
Our pharmacovigilance (PV) literature monitoring solution provides a comprehensive, modular approach to literature surveillance for pharmacovigilance. It provides organizations tasked for drug safety reporting a smooth, efficient, and compliant process for the entire literature triage process.
- Global literature monitoring
- Monitoring of the EMA’s Medical Literature Monitoring (MLM) and assessment of safety information
- Literature monitoring to supports the aggregate reports and signal management process
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
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)
- Canada Annual Summary Report (CASR)
- Development Safety Update Report (DSUR)
- ACO reports – Addendum to clinical overview
Our pharmacovigilance (PV) literature monitoring solution provides a comprehensive, modular approach to literature surveillance for pharmacovigilance. It provides organizations tasked for drug safety reporting a smooth, efficient, and compliant process for the entire literature triage process.
- Global literature monitoring
- Monitoring of the EMA’s Medical Literature Monitoring (MLM) and assessment of safety information
- Literature monitoring to supports the aggregate reports and signal management process
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
Current Challenges.
- Lack of standardization in reporting and data collection
- Challenges in data management, analysis and interpretation
-
Lack of expertise and resources to handle pharmacovigilance
activities effectively - Increasing regulatory requirements and expectations
-
Globalization of drug development, resulting in an increase
in data volume and complexity
How YouV could help.
- Utilizing advanced technologies to improve data management, analysis, and interpretation
- Continuous Investment in staff training and development to enhance expertise in pharmacovigilance
- Robust systems and processes in place to ensure compliance with regulatory requirements
- Building strong partnerships with sponsors to understand their specific needs and tailor solutions accordingly
Case Studies.
Adding value to your businesses through our services
Other Expertise.
Biostatistics
Clinical Data Management
Medical Writing
