Signal Management Services
Safety signal management is a crucial process in pharmacovigilance to determine whether there is a causal association between a drug and an adverse event, and if so, to take appropriate action to minimize the risk to patients.
With our team of PV Experts, we help sponsors, MAHs and Medical Device companies to analyze and interpret safety signals across their product portfolio. We aim to provide value for our clients with the following benefits:
Early Detection of Safety Issues
Using Oracle Empirica Signal, our team can establish a comprehensive signal detection process to minimize risk to patients and reduce the likelihood of legal and financial consequences for drug manufacturers.
Data-driven Safety Decision-Making
Our signal management process involves an in-depth analysis of aggregated safety information that helps our clients to take informed decisions, implement better risk management strategies and improve patient outcomes.
Proactive Regulatory Compliance
We use advanced statistical methodologies and data mining techniques to discover and timely report product related safety risks to National Competent Authorities of validated signals detected when monitoring the safety database.
At Techsol, we have the expertise to deliver both the technical and functional activities related to Signal Management. As an Oracle Health Sciences Partner, our team of PV Technical Consultants can complete the rapid implementation of Emprica Signal and Topics applications for your organization. Our functional team of PV Experts and Scientific Professionals can deliver end-to-end Signal Management services for different types of medical products and devices.
Our Delivery Capabilities
- Expertise in using industry-leading Oracle Empirica Signal and Topics applications
- Well-documented signal management process that accounts for accuracy and quality
- Authoring of Signal Reports, Quality Review, and Medical Review.
- Preparation of Signal schedule and Maintenance signal tracker
- Screening Regulatory authority websites for safety communication
- Effectively communicating complex information
- Applying latest methods in scientific research
- Leveraging latest technology for content creation
- Always meeting timelines and avoiding delays
Services We Offer
Our team has the expertise to perform signal management based on GVP Module IX updates. Following are the activities we perform:
1. Data Collection
As a first step, we ensure that our client PV Teams have an established process to collect data using a validated safety database from various sources such as spontaneous reports from healthcare professionals, clinical trials, and observational studies.
2. Signal Detection
We use advanced statistical packages and perform qualitative and quantitative review of ICSRs for accurate safety signal detection. If required, we also complete the assessment of aggregated data to complete signal detection.
3. Signal Evaluation and Validation
> Further evaluation and signal assessment of the Identified signal. Recommendation of actions for the signals will be suggested as a consequence, which includes risk classification and proposals for risk minimization measures.
> Examining the strength of the evidence as per GVP recommendations.