Pharmacovigilance & safety services

Experience superior safety and regulatory compliance with Synapmed’s comprehensive pharmacovigilance services. Our commitment to excellence ensures timely and efficient processing and analysis of safety cases, while our in-house team of experts manages your product portfolio within a globally integrated environment. By staying current with industry trends and requirements, we provide you with reliable, high-quality support that enhances your operational efficiency and safety outcomes.

Ensure top-tier safety and compliance through expert pharmacovigilance

Our pharmacovigilance services are designed to not only meet but exceed regulatory expectations. By leveraging a fully integrated, global pharmacovigilance framework, our expert team focuses on compliance, proactive management, and superior customer service. Our streamlined processes enhance quality while reducing time and costs. Discover how Synapmed’s approach addresses your safety and regulatory needs through the use cases below.

End-to-end case management for streamlined processing

Digitized intake and seamless transfer using ADRium-Intake and ADRium-Safety; includes triage, data entry, medical review, quality check, and submission
Dynamic module for ICSR validity, report type identification, duplicate checks, and accurate data registration into ADRium-Safety
Criteria-based assessment for ICSR validity, product identification, seriousness, causality, and case prioritization

Thorough data management for accuracy and efficiency

Comprehensive data entry from source documents into ADRium-Safety; includes patient, reporter, and clinical details with auto-population into E2B format
Evaluation of case seriousness, causality, clinical assessment, signal identification, and MedDRA coding accuracy
Coordination with stakeholders for efficient reconciliation and regulatory submissions

Advanced reporting and signal detection for informed decision-making

Creation and submission of aggregate reports such as DSUR, PBRER, PADER, CSR; includes planning, data collection, and report finalization
Comprehensive signal detection with ADRium Signals for both quantitative and qualitative analysis

Effective risk management and information handling

Development and implementation of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS); ensuring effective risk mitigation
Management of medical information queries and processing of adverse events and product defects through call centers and mailbox management

why synapmed?

Synapmed delivers advanced pharmacovigilance solutions designed to meet the highest regulatory standards.

Our end-to-end services, from case processing to aggregate reporting, ensure thorough management of drug safety and development data. With our integrated approach and expertise, we streamline your operations, enhance compliance, and optimize outcomes.

Our commitment to quality and efficiency, backed by robust technology and experienced professionals, helps you navigate the complexities of pharmacovigilance and achieve your business objectives with confidence.

Frequently asked questions

What is pharmacovigilance and drug safety?

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It play sa crucial role in ensuring drug safety by monitoring the effects of pharmaceutical products after they have been released into the market. Effective pharmacovigilance helps to identify potential safety issues, ensuring that the benefits of a drug outweight its risks.

Why is pharmacovigilance compliance important?

Compliance with pharmacovigilance regulations is essential for protecting public health. It ensures that pharmaceutical companies monitor and report adverse drug reactions (ADRs) effectively, which is crucial for maintaining drug safety and efficacy. Non-compliance can lead to severe consequences, including regulatory penalties, product recalls, and damage to a company’s reputation.

What is included in your pharmacovigilance case processing services?

Our pharmacovigilance case processing services encompass the entire lifecycle of case management, including digital intake, data entry, medical review, and quality checks. We use our ADRium-Intake and ADRium-Safety platforms to ensure accurate and efficient case processing.

How does Synapmed handle pharmacovigilance case registration?

Synapmed’s ADRium Intake module dynamically manages case registration by validating source data, performing duplicate checks, and ensuring proper case registration. We seamlessly populate data into our ADRium-Safety database for comprehensive management.

What does pharmacovigilance medical review entail at Synapmed?

Our medical review process involves assessing the seriousness and causality of cases, performing clinical evaluations, signal identification, and ensuring accuracy in MedDRA coding. Our experts ensure all aspects of the case are thoroughly reviewed and validated.

Can you explain your approach to ICSR reconciliation?

Our case processing team manages ICSR reconciliation by collaborating with stakeholders and safety partners to ensure all cases are accurately reconciled and compliant with regulatory requirements. This process includes reconciling discrepancies and ensuring completeness for regulatory submissions.

What services do you offer for pharmacovigilance risk management?

We design and implement comprehensive Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) to address potential risks associated with drug products. Our risk management services aim to enhance safety and effectiveness while ensuring regulatory compliance.

How does Synapmed support signal detection and management?

Our ADRium™ Signals module provides a complete solution for signal detection and management, including quantitative and qualitative analysis. We identify drug-event combinations that meet statistical thresholds and perform detailed analysis for effective signal management.

What types of aggregate reports does Synapmed prepare?

We prepare a range of aggregate reports including Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER), Periodic Adverse Drug Experience Reports (PADER), and Clinical Study Reports (CSR). Our medical writing experts ensure these reports are comprehensive and submission-ready.

How does Synapmed ensure compliance with evolving regulatory requirements?

We stay updated with regulatory changes and implement necessary adjustments to our processes and systems. Our pharmacovigilance services help clients adapt to new regulations and ensure their practices meet current industry standards.

What is the process for integrating your pharmacovigilance services with existing systems?

We provide seamless integration services, linking our pharmacovigilance platforms with your existing systems to ensure smooth data transfer and operational efficiency. Our team supports the integration process from initial setup to ongoing maintenance and support.

“Synapmed allows us to build expertise within our company while also outsourcing the administrative aspects. When you work with most vendors, it becomes an assembly line, and quality goes down. Or they take over completely, and we lose oversight. Synapmed is a part of my team, so we get to maintain and retain the quality.” 

“I build and fix departments and Synapmed has been part of that journey with me. We wanted to come up with a safety profile for one of our drugs. Because of the performance of competitor generics, it was getting a bad name. Synapmed mined the data, analyzed our product versus generics from a safety perspective, and wrote an article and abstract on the findings that was very productive.”

What is the Right Outsourcing Strategy for Your Company? Not One Model Fits All

Pharmacovigilance (PV) is crucial for the pharmaceutical and biotech industries as safety regulations grow increasingly complex. Companies encounter challenges in managing rising data volumes, resulting in higher costs and a need for specialized expertise. In response, many organizations are outsourcing PV functions to cut costs and tap into expert knowledge. Successful outsourcing hinges on careful partner selection aligned with specific needs, while retaining essential tasks in-housed when necessary. By effectively managing these partnerships, companies can navigate the complexities of pharmacovigilance while concentrating on their core competencies.

Dedicated to youR Project

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. We’re a team that listens, pays attention to details, and brings smart insights to the table. We do it all so you can solve real problems throughout the product development and commercialization lifecycle.

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