signal management
Including signal detection, validation, prioritization, and assessment
Signal Management Services
ProPharma has deep expertise across all signal detection and management activities, including validation, prioritization, and assessment using data from a wide range of sources that are relevant for signal detection for the individual product(s). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. We leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.
ProPharma's simple but scalable model of signal detection and management allows clients to obtain the exact services necessary throughout the entire life cycle of their products.
Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products that require the utmost expertise. Signal management can be deployed throughout both the clinical development and post-marketing phases of the product lifecycle. Safety issues may affect the benefit-risk balance of the product, requiring updates to product labels and other steps that help protect patients from harm.
Signal Detection in Pharmacovigilance
Signal detection in pharmacovigilance is the systematic process of identifying and evaluating potential safety signals in the data relating to a pharmaceutical product. This process involves scrutinizing various data sources for previously unrecognized adverse events or changes in patterns of known adverse events, which might be caused by a medicine. This is vital to monitor and assure the safety of a pharmaceutical product throughout its life cycle.
Key Steps in Signal Management
-
Signal Detection: Identifying potential safety signals using various data sources such as adverse event databases, literature, and other data.
-
Signal Validation: Verifying the identified signals to ensure they are genuine and warrant further investigation.
-
Signal Confirmation: Ensuring that the identified signal is supported by robust, scientific evidence.
-
Signal Assessment: Analyzing the available data to evaluate the relationship between the medicinal product and the observed risk and providing recommendations for mitigating risk to patient safety.
-
Communication: Working with the Client to inform regulatory authorities, healthcare professionals, patients, and the public about the findings and any new safety measures or recommendations resulting from signals in the management procedure.
-
Documentation: Recording all activities, assessments, decisions, and communications for accountability and future reference.
Significance of Signal Management
-
Patient Safety: Ensures that any potential safety concerns with pharmaceutical products are identified and managed to safeguard patients.
-
Regulatory Compliance: Ensures that regulatory requirements for monitoring and ensuring product safety are met.
-
Informed Decision Making: Helps healthcare professionals and patients make informed decisions about medicinal products.
-
Risk-Benefit Balance: Ensures that the benefits of a pharmaceutical product continue to outweigh its risks during the entire lifecycle.
How ProPharma Overcomes Signal Management Challenges
-
Data Quality: Defining robust strategies to analyze available data.
-
Timely Decision Making: Ensuring that decisions and communications are made in a timely manner to protect public health.
-
Global Consistency: Globally harmonized processes to collect, process, and assess data.
News & Insights
April 23, 2024
Meet the Expert: Sarah Giorgio
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
March 26, 2024
EU Pharmaceutical Legislation Reform: Where Are We Now?
On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
April 10, 2024
ProPharma Announces Changes to Its Executive Leadership Team
Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights
April 18, 2024
ProPharma Now Certified as Medidata Rave EDC Accredited Partner
Leading Research Consulting Organization (RCO) Receives Medidata Accreditation for the RAVE EDC Module, Enhancing Clinical Trial Efficiency and Data Integrity for sponsors. RALEIGH, April 18, 2024 –...
January 24, 2024
ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology
RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...
November 27, 2023
EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
October 11, 2023
ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...