HELPING COMPANIES NAVIGATE THE COMPLEXITIES OF DRUG SAFETY COMPLIANCE.
DRUG SAFETY NAVIGATOR
Drug Safety Navigator is a pharmacovigilance (PV) company focused on helping our pharmaceutical and biotech clients navigate the best course to maintain patient safety -- from adverse event reporting and medical monitoring to call center support and PV system audits. With a nimble approach and a team with extensive real-world experience, we’re dedicated to our client's patient safety in an increasingly complex regulatory landscape.
WHO WE ARE
At DSN, unlike the larger CRO's, we put a premium on deep experience, hands-on customer service and flexible methodologies. What does that mean for you? Our senior team -- with an average of more than 15 years experience in the PVG & drug safety market – is engaged on your project, every single day.
We understand that your organization has unique needs, which is why DSN offers a flexible engagement model for our clients. In some situations, we work on a project basis and for other clients, we are a fully-outsourced extension of their organization, serving as their virtual safety department with global pharmacovigilance support for both clinical and post-marketed medical products.
By using modern technology and leveraging our highly-experienced safety managers, our clients gain the benefits of a world-class safety department that works collaboratively to ensure accurate data capture.
We look forward to the opportunity to engage with you and help solve your most daunting challenges.
ADVERSE EVENT REPORTING
Data Collection & Management, Simplified.
DSN provides comprehensive AE/SAE Case Management services utilizing Oracle Argus Safety Database in the Cloud. The system is hosted by a premier Life Science Hosting Administrator, who utilizes an ISO 9001-certified Quality Management System to deliver GxP compliant hosting across two dedicated Data Centers. With 24/7 support from our host, DSN can focus on case management from receipt to reporting without having to support a large IT infrastructure. That translates into more time focused on your project, delivered at a better price point.
REGULATORY INSPECTION PREPARATION
Ensuring your Team & Processes are Ready.
In the pharmaceutical industry, inspections are a fact. And recently, there has been significant regulatory focus around PV quality management systems and an increase in regulatory inspections. At DSN, we work with companies to apply a risk-based approach to develop an inspection strategy that will ensure companies are prepared for the inevitable audit. Our team includes a former FDA inspector with extensive experience with inspection preparation and mock audits. DSN applies pharmacovigilance practices that will help your organization sail through a regulatory inspection. And most importantly, we ensure a safe risk benefit profile for your product.
Contact us today so we can help you prepare.
SAFETY SIGNAL DETECTION
Proactive Reviews Lead to Better Outcomes.
Companies have an ethical and legal obligation to monitor the safety of their drug(s) throughout its life cycle and safeguard public health by identifying risks and putting in place appropriate mitigation measures.
DSN understands the importance of signal detection as a key component of a robust pharmacovigilance program and works closely with companies in monitoring and detecting new safety issues that may emerge. DSN can perform routine monitoring of safety data as well as apply the appropriate level of safety signal workup for identified safety risks.
Get to know the team in person! Call us today at 919-885-0549.
WHAT OUR CLIENTS SAY
There are few things as rewarding as a successful collaboration with our clients that solve their challenges. Our team of professionals use their years of experience and knowledge to create lasting and rewarding relationships with our clients and partners. Check out what our clients are saying about working with Drug Safety Navigator.
“As part of our full-service offering, Lexitas is very proud to partner with Drug Safety Navigator for pharmacovigilance operations. Molly has been a trusted colleague for nearly a decade, and along with her team, we consistently receive excellent and expert service possible. The DSN team excels at ensuring that the needs of clients are met, particularly the assurance of compliance with FDA regulations regarding drug safety reporting. DSN has been a great partner on numerous studies including several pivotal trials due to their knowledgeable counsel, excellent responsiveness, and superb teamwork."
Chad Ice, President, Lexitas
Some of our Key Clients & Partners
HOW CAN WE HELP YOU?
We offer flexible solutions for our clients, from projects to serving as their full virtual safety department.
Drug Safety Navigator solves each client’s issues by providing a comprehensive approach backed by our team of experienced professionals. Our process fosters collaboration and innovation to ensure we not only understand the core needs of clients, but also help them develop successfully. Below are just some of the ways we can help you tackle your toughest challenges. Let's talk.