Detection, Validation, Assessment, and Tracking
OUR TEAM OF EXPERIENCED PROFESSIONALS CAN SUPPORT YOUR SIGNAL MANAGEMENT NEEDS
Our highly qualified team of Pharmacovigilance (PV) experts are available to support your organizations signal management needs. Adopting both quantitative and qualitative methods and utilizing multiple data sources, we partner with you to ensure that you are able to detect, validate, assess, and track signals.
What is Signal Management?
ARE YOU LOOKING TO OUTSOURCE YOUR SIGNAL MANAGEMENT?
We provide Signal Detection Services
- Screening PV databases
- Screening homepages of competent authorities
- Literature searches in dedicated databases
- Comparison of reference safety information with innovator/comparator UPSI/SmPC
- Qualitative and Quantitative Signal Detection activities using appropriate tools
We provide Signal Validation Services
- Signals are validated by our experienced medical resources and evaluated against all available evidence for any additional information on the drug-event pair.
- Evidence is documented and, if qualified, the drug-event pairs will be processed in the next step of assessment
We can support or assume responsibility for the authoring of your
- Providing a medical evaluation of those products that are in development and post-marketing.
- Further recommendation of actions for the signal(s) will be suggested as a consequence
We establish ongoing Signal Tracking that ensures all stakeholders are informed of signals and have access to their associated information.
- Providing a signal tracker with agreed timelines for evaluation and compliance tracking
- Delivering manual and/or technological support in tracking signals for your molecules on a periodic basis
We conduct efficiency and effective Safety Review Meetings under the supervision and guidance of our
- Delivered by our PV Specialists and Medical experts
- Detailed meetings will be conducted on a periodic basis (monthly or quarterly as agreed) in order to implement decisions informed by signal management activities
We develop Risk Management Plans and other Risk Minimization Documents for your medicinal products as per Health Authority requirements.
- Maintain the tracker for Risk Management plans
- Track risk minimization measures agreed for the molecule(s)
ADVANTAGE OF OUTSOURCING YOUR SIGNAL MANAGEMENT REQUIREMENTS TO NAVITAS LIFE SCIENCES
Experienced team with optimal infrastructure
Cost effective and efficient support
Ability to scale to suit specific needs
WE CAN SUPPORT YOUR ORGANIZATION WITH THE FOLLOWING ACTIVITIES:
- Generating Line Listing Reports (for both the review and the cumulative period)
- Executing Literature Searches, Review, and Full Text Order
- Performing Qualitative and Quantitative methods using disproportionality statistics including Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), and Empirical Bayes Geometric Mean (EBGM) values
- Screening competent authority websites including PRAC agenda minutes, Drug Safety Communications, and WHO newsletters
- SmPC/Product information comparison and presenting a recommendation
- Authoring Signal Reports, Peer Reviews, and Medical Reviews
- Providing feedback and comments on Signal Reports
- Our in-house QPPV team provides oversight, reviews signals, and offers valuable recommendations
- Analyzing and defining the risk management strategy and best practice-based Signal Detection and Management process
- Conducting Safety Review Meetings
- Maintenance of Signal schedule, ongoing signal tracker, and managing progression