Signal Management
Services

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.

Image
Image

What is Signal Management?

The EMA Good Vigilance Practice (GVP) Annex I defines the Signal Management process as “A set of activities performed to determine whether, based on an examination of individual case safety reports (ICSRs), aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there are new risks associated with an active substance or a medicinal product or whether known risks have changed, as well as any related recommendations, decisions, communications and tracking.”

ARE YOU LOOKING TO OUTSOURCE YOUR SIGNAL MANAGEMENT?

At Navitas Life Sciences our End-to-End Signal Management Services include:
Signal Detection

Signal Detection

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
Signal Validation

Signal Validation

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
Assessment Reports

Assessment Reports

We can support or assume responsibility for the authoring of your
Assessment Reports.

  • 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
Signal Tracking

Signal Tracking

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
Safety Review Meetings

Safety Review Meetings

We conduct efficiency and effective Safety Review Meetings under the supervision and guidance of our
in-house QPPV

  • 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
Risk Management

Risk Management

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

Experienced team with optimal infrastructure

Domain experts

Domain experts

Cost effective and efficient support

Cost effective and efficient support

Ability to scale to suit specific needs

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

Learn how we are delivering End-to-End Global Signal Activity Services to a mid-sized global pharma company

Reducing costs, increasing efficiency and compliance, and improving patient safety