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.
OUR SAFETY SOLUTIONS
Drug Safety Navigator exists to solve the critical issues facing our clients, both large and small. Our engagement model is flexible. We work on a project basis for some of our clients and for other clients, we serve as their virtual safety department. In addition to the solutions below, we also offer support for Medical Information and Call Center support, Aggregate Report Preparation, Medical Writing, and Adverse Event Coding (MedDRA, WHO Drug, etc.)
The DSN team includes more than a dozen professionals in North America (based predominantly in our offices in Research Triangle Park, NC), as well as additional subject-matter experts in the areas of regulatory prep, medical monitoring and writing, and quality reviews. Our team has deep industry experience from firms such as Quintiles, PPD, UCB/Schwarz Pharma, and Drug Safety Alliance, among others. Our management team includes DSN principals Molly James and Lynda Spiker, as well as Kristina Keeler and physician Ricardo Velazquez.
MOLLY JAMES, BSN, RN
Partner & President
Molly joined DSN when her firm - Five Oaks Pharm -- was acquired in 2014. She has more than 30 years of nursing experience, with 16 years of experience in pharmacovigilance. Molly has expertise in all strategic and tactical safety operations, including database management, safety process planning, quality and compliance and training. She is a subject matter expert in safety management plan development and workflow processes. Prior to DSN, she held positions at UCB/Schwarz Pharma, Drug Safety Alliance (DSA), PPD, and Inspire Pharmaceuticals. Molly earned her BSN with honors from The University of Michigan, Ann Arbor, MI. In addition to PVG, Molly loves to travel and hike the Blue Ridge mountains around her Asheville home.
LYNDA SPIKER, RN
Partner & VP, Global Safety Operations
Lynda has more than 30 years of nursing experience, with 16 years of experience specifically in the PVG/drug safety market. Lynda has expertise in all strategic and tactical safety operations, including database management, safety process planning, quality and compliance and training. She is a subject matter expert in safety management plan development and workflow processes. Prior to joining DSN in 2016, she held roles leading firms such as PPD, DSA, UCB/Schwarz Pharma and CTI. She earned a nursing degree from The Helene Fuld School of Nursing (Camden, NJ), part of Rutgers University in Philadelphia. When not working, you'll likely find Lynda running or riding her horses.
Director, Global Safety Operations
Kristina brings more than eight years of experience in the healthcare and the pharmaceutical industry. She previously functioned as a Program Director at Ashfield Pharmacovigilance, where she was responsible for establishing a call center allowing for substantial business development in addition to client services, project oversight and client onboarding. Additionally, Kristina is a subject matter expert in Call Center Operations and has extensive experience in developing and leading call center projects. Before joining DSN, Kristina also had roles at Quintiles and WRB Communications. She has her B.A. in Business Administration, 2012 from Averett University in Danville, VA.
RICARDO VELAZQUEZ, MD
Lead Medical Reviewer
Ricardo Velazquez, MD, Drug Safety Navigator’s Lead Medical Reviewer, is currently responsible for medical and literature reviews, ongoing signal detection, and regulatory authority responses. Dr. Velazquez attended Aureus University School of Medicine in Aruba, and completed his clinical training at various medical institutions in the Baltimore and Washington, DC area. Dr. Velazquez has a keen interest in the benefit-risk assessments of medical products during clinical development and post-marketing, and provides such risk management and risk minimization strategies during these crucial stages. His previous clinical training focused on Research and Psychiatry.
Get to know the team in person! Call us today at 919-885-0549.
24/7 Secure Platform Access
OUR TECHNOLOGY PLATFORM
A strong, secure technology foundation is critical to a successful pharmacovigilance operation and at DSN, we take technology very seriously and understand it is an important enabler to support our clients.
Our hosted database approach enables secure 24/7 access, providing our clients with a flexible, scalable and cost-effective pharmacovigilance repository and reporting solution. DSN uses the Oracle Argus Safety version 8.1 multi-tenancy database.
Oracle Argus Safety Database
Some key features of Argus are:
21 CFR Part 11 fully compliant and validated system with 24/7 support
Full reporting capabilities, including individual case and aggregate reports
Supports E2B file exporting and importing
Compliance Reports and Frequency Reports for Signaling Detection
ISO 9001 and ISO 27001-certified.
CLIENT SPECIFIC INSTANCES
Secure, Hosted Cloud
DSN will configure a client specific instance within this cloud-based safety database. This client specific instance is completely secure and separated from other instances and sensitive data.The system for DSN and our clients is hosted by an outside provider that enables us to provide around-the-clock database monitoring and maintenance activities including server maintenance, routine back-ups, disaster recovery, and security monitoring.
Data to Make Better Decisions
We can provide a variety of reports including:
CIOMS II Line Listings
AER Data Reports
Case Processing Metrics
Signaling and Frequency Reports.
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.
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.
INTERESTED IN CONDUCTING CLINICAL TRIALS IN THE U.S.?
DSN has worked with several partners looking to expand into the U.S. market. Key considerations include DSN's expertise in supporting a successful clinical safety program focusing on protocol and IB reviews, management of SAEs during the trial, compliance with FDA regulatory requirements for SUSAR submissions, required Annual Safety Report or DSUR, and medical writing for end of study Clinical Safety Report and patient narratives to support goal of application for FDA approval. Contact us today to learn more.
NEED HELP WITH MEDICAL CALL CENTER SUPPORT?
Our team has firsthand experience establishing, staffing and monitoring medical information call centers. It’s more than just answering calls. Knowledgeable, well trained staff are the front end of your firm’s brand impression and key to a positive outcome with your patients/customers. DSN provides flexible options from managing inquiries on a specific product to a comprehensive medical information program, staffed by seasoned medical professionals.
INTERESTED IN MARKETING A NEW DRUG PRODUCT IN THE U.S.?
DSN has worked with several international partners looking to expand into the U.S. market. Our team has expertise in supporting a successful Post Marketing safety programs compliant with FDA regulatory requirements to support the goal of compliant U.S. marketing and successful FDA inspections.
ARE YOU A CRO LOOKING FOR AN AGILE & FLEXIBLE PV PARTNER?
As a CRO, your key focus is successfully managing clinical trials. Pharmacovigilance, while important to you, is not a core competency or a target investment area. DSN can help. We work with small- to mid-sized CRO’s to serve as their virtual PV departments, achieving best practice results without the overhead investment. Learn more by contacting us today.
NEED AN EXPERT PV SYSTEMS AUDIT?
Did you know that more than 30% of current PV systems do not meet FDA requirements for appropriate training or adequate procedural documentation? An audit is a smart way to ensure you’re on the right path with your current approach. DSN has conducted dozens of systems audits to ensure compliance and that your firm will be in good shape in the event of an regulatory audit. A small investment can save your study and significant dollars down the road (and help you avoid a 483 finding!)
ARE YOU A SMALL PHARMA WITH PHASE I OR II IN EARLY DEVELOPMENT?
At this point in your journey, key considerations will be things like is the safety section of your protocol compliant? Is your reference safety information (RSI) information up to date and reviewed in alignment with your annual development safety update report? DSN has extensive experience with Phase I/II drug prep to ensure organizational readiness. Reach out to us today and we’ll share more of our insights.
“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
"Having worked with the DSN team, I know personally the dedication, expertise, and commitment to quality and service they exhibit every day for their clients. “
Michael J. Klepper, MD, and Author of
"Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk"
Some of our Key Clients & Partners
"Ultimately, the goal for each of our clients is achieving 100% compliance. Our team takes that responsibility very seriously."
Molly James, DSN President
A short, introductory conversation can help us understand your current challenge or opportunity and how we might be able to work together. We look forward to connecting!
Drug Safety Navigator (DSN)
Office Address: 1906 E. NC HWY 54, Suite 200-D
Durham, NC 27713
Mailing Address: 510 Meadowmont Village Circle, Suite 282
Chapel Hill, NC 27517