24 Sep 24

How Fidelity Is Supporting Its Client With Global Pharmacovigilance Activities

Pharmacovigilance and Drug safety activities are the obligatory requirements for safeguarding patient health, maintaining drug safety, and adhering to global and local regulations. At Fidelity Health Services, our bouquet of entire pharmacovigilance offerings allow pharmaceutical companies to handle complex safety data, manage adverse event reports, and meet compliance requirements.

Moreover, partnering with experienced pharmacovigilance providers can help drug manufacturers optimize their operations, mitigate risks, and improve patient safety throughout the drug development and its life cycle.

Thorough Clinical Trials Safety Monitoring and Pharmacovigilance

Fidelity's pharmacovigilance services cover every stage of a drug's lifecycle, starting from clinical trials to post-market surveillance. We assist our clients in upholding the highest patient safety standards by utilizing global best practices, advanced tools, and a proactive approach to pharmacovigilance management. Our services help drug manufacturers concentrate on innovation while staying compliant with safety regulations.

Medical Information Call Center (MICC) Services

Medical Information Call Centers (MICCs) is key source to receive the safety information as well as product quality defects notification from the market, providing essential communication support for healthcare professionals, patients, and consumer. Our MICC services help manage inquiries through phone, email, and social media channels, addressing medical inquiries, product quality issue, adverse events, etc.

Our MICC service includes:

To provide services that are both affordable and compliant, our MICC service includes a selection of approach models.

24*7 model: We offer MICC services to clients in which medical call center professionals are on available around-the-clock to take calls from and assist customers.
The 8*5 model, also known as the weekday model, is a cost-effective and compliance solution for clients. Our healthcare professionals are available on call to attend to customers' calls throughout business hours on weekdays. Any calls made to hotline or toll-free numbers are sent to voicemail and will be addressed the next business day.

Fidelity Health Services has tied up with the globally renowned telephony partners, so we can handle any requests from clients for toll-free numbers, making the MICC setup hassle-free for our clients.

We provide scientific responses to the customer's based on official documentation as well as published scientific literature.

Individual Case Safety Report (ICSR) Processing

ICSR processing is a fundamental component of pharmacovigilance activity. Fidelity Health Services manages the process from adverse drug reaction (ADR) intake to regulatory submission making sure that companies comply with international standards, such as FDA and EMA and all other regulatory authorities. Our ICSRs and case processing services help pharmaceutical, and biopharmaceutical companies streamline drug safety and compliance.

Safety Signal Detection

Drug safety signals are not a novel idea. The foundation of pharmacovigilance efforts is the signal detection method. However, as more medicinal products are authorized for marketing each year and as increasing numbers of people are taking medicines, this has resulted in an increase in the number of adverse events reported to manufacturers and to regulators.

Fidelity Health Services have PV safety database containing several adverse event reports or ICSRs, that is able to detect, prioritize, and evaluate signals in an efficient and proactive manner. We adopt the following steps is signal detection process:

Signal detection
Signal validation
Signal confirmation
Signal Analysis
Signal prioritization
Signal assessment
Recommendation of actions

Risk Management Plan

A Risk Management Plan (RMP) service offered by Fidelity Health Services is designed to ensure the safety of patients and the effective use of medicinal products. This service includes the development, implementation, and continuous monitoring of a comprehensive risk management strategies and appropriate measures, in compliance with regulatory requirements. Fidelity Health Services works to identify, assess, and mitigate potential risks associated with a medicinal products, device, vaccines detailing risk minimization measures, safety studies, and regular updates to ensure the product's safety profile is continuously evaluated and optimized throughout its lifecycle.

Global Regulatory Compliance and Reporting

Fidelity helps pharmaceutical companies meet international reporting requirements, including ICSRs and periodic safety updates, by verifying all submissions align with FDA, EMA, and other regional standards. Our expertise in global regulatory compliance helps pharma companies to achieve required compliance.

Automation for Smarter Pharmacovigilance

Data-driven insights are transforming pharmacovigilance. Integrating automation helps clients to assess safety data, evaluate trends, and manage risks more efficiently. By utilizing high end technology, companies can make informed decisions that strengthen their product safety profiles and improve overall pharmacovigilance processes.

Literature Monitoring Services

Literature monitoring is essential for identifying new safety information and emerging risks. Fidelity's literature monitoring services include the ongoing review of medical and scientific publications to detect relevant information related to drug safety.

Periodic Safety Reporting

Periodic safety reports (PSURs and PBRERs) are the most important documents that evaluate the safety profile of medicinal product for cumulative period of time and also aligns with compliance with global regulations. Fidelity's core experience of turning around more than 2200+ periodic reports annually can serve the clients with utmost quality reports and maintains the compliance.

Why Partner with Fidelity Health Services?

We bring industry expertise, latest and high end technology, and a commitment to drug safety to our pharmacovigilance services. From MICC management to signal detection, we offer a full suite of services designed to reduce risks, meet compliance standards, and support successful product lifecycles.

Furthermore, our comprehensive approach helps pharmaceutical companies maintain a strong focus on patient safety while navigating the complexities of regulatory demands.

Contact us for more information on how Fidelity Health Services can drive your pharmacovigilance strategy, or visit our website