2012 2013 corporate capabilities
DESCRIPTION
Your Clinical Research PartnerTRANSCRIPT
Corporate Capabilities Brief
2012-2013
Your Success is Our Success!
EmpiriStat, Inc., 13694 Sam Hill Drive, Mount Airy, MD 21771
1-866-935-STAT or 240-744-0000 Fax 866-276-STAT www.empiristat.com
EmpiriStat, Inc.
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At EmpiriStat our work lies at the intersection of science and practice, in collaboration with partners for
the design, implementation and analysis of clinical trials and research studies. With our in-depth
biostatistical and methodological experience, we navigate through the myriad of regulations and research
guidelines to ensure a successful clinical trial and clinical program, and even more importantly,
relationship with the US and European regulatory bodies that may be involved in that pathway. We
operate as members of the team, while moving our client’s product forward on its given timeline.
EmpiriStat provides research support for animal model studies, in-vivo and in-vitro diagnostic testing and
full Phase I to IV clinical support, with post marketing analysis throughout a wide range of therapeutic
areas and devices. We offer a variety of customizable services of high-end development and knowledge
in:
Biostatistics and Statistical Programming
Regulatory planning, support & submission
for INDs, BLAs, PMA, 510ks, and IDEs
Data and Safety Monitoring Board services
(masked and unmasked statistical support),
Charter Services and Administrative Duties
Clinical Data Management support
Risk Based Monitoring
Epidemiological Cohort and Longitudinal
Studies
Capacity Building Training for Existing and
Developing Programs
Clinical Research Support Staffing for
Government and Industry
EmpiriStat’s founder Dr. Nicole C. Close wasn’t satisfied to cruise the easy road, she has continually
challenged herself and those around her. Under the guidance of mentors she was encouraged to think
beyond boundaries. This no-limits approach became a unique part of her professional methodology. In
March of 2008 with a unique goal in mind: to discover the truth as far as possible, EmpiriStat was born.
It has always been EmpiriStat’s position to provide comprehensive and cost efficient clinical development
options while delivering the highest quality product. Responsibility to each other and to our clients is
our expectation.
With established key relationships in Biotechnology, Industry, Government, and Academic clients,
EmpiriStat has developed an unparalleled ability to
provide comprehensive services. This, in combination
with a powerful team of subject matter experts in
scientific, regulatory, and logistical aspects of clinical
research, EmpiriStat has the ability to understand our
client's goals and provide the necessary contributions
required to achieve them. Driven by our passion for
science and overcoming the challenges associated with
research, we can confidently state that our clients’
success is our success. We genuinely care about our collaborators. We get to
know them, their families, their hobbies and we share
with them as well. It’s the personal attributes of our
team that makes us easy to work with and our passion
and excitement for science and research is evident in all
we do.
Corporate Summary
Quick Facts
Woman-Owned Small Business
CAGE Code: 53F97
DUNS Number: 826391034
Small Business NAICS 518210,
541519, 541611, 541690, 541712,
541720, 541990, 611420, 611430
FWA 00015488
Navy FWA Addendum
Air Force FWA Addendum
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Strategic U.S. Clinical Development Partner
Statistically and Methodologically Focused for Design,
Implementation and Analysis
Expert Therapeutic, Industry, and Regulatory Knowledge
Proven And Successful Track Record
Close Proximity To The FDA and Working Knowledge of FDA
Divisions and BIMO
Personalized "Hands-On" Customer Focus
Seamless, Secure Virtual Approach
Outstanding Communication
Flexible and Responsive
Competitive Cost Structure / Tailored Services
Dedicated Team for the Program/Client
Simply Put… We are Energetic, Love our Careers and are FUN
to Work With
Recognized by the business community:
o Voted the Best Place to Work in Frederick, Maryland
(Small Business) in 2011
o Voted 2012 Frederick County Technology Awards, Small
Business of the Year
o Voted 2011 Entrepreneur of the Year for Women in
Technology, Dr. Nicole C. Close, Washington, DC
Why EmpiriStat
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It takes a team approach for the successful completion of a research study or for the development of a
new device or drug product. It entails substantial integration of collaborators, both internal and external,
to research, develop, register, and ultimately market a new product. In order to achieve success one must
be able to effectively orchestrate these complex tasks.
EmpiriStat has collaborated with clients and organizations in almost every industry and specialty—both
in the U.S. and countries around the world. We have developed and refined a rigorous, effective
foundation of methodologies that are fluid yet repeatable—enabling us to quickly adapt to each new
project and provide the high level of personal service and reliability that is the core of our reputation.
EmpiriStat's Methodologies Adapt to Every Industry and Therapeutic More and more pharmaceutical and biotech companies are strategically outsourcing their development
needs to CRO partners that have exceptional skills in defined areas. As a result, the role of the CRO as a
service provider is rapidly changing. Companies are now moving toward a strategic outsourcing model
to maximize clinical development efficiencies and product quality. And as industry diversifies, EmpiriStat
is able to adapt and promote our strong capabilities within specific areas and stages of drug development,
rather than simply providing time and material support as the traditional CRO does. We have
successfully and seamlessly integrated into our collaborators development programs, not only by
providing operational support and services, but by providing strategic insight into the unique clinical
development challenges.
EmpiriStat, Inc. is ideally positioned to provide the most value to our collaborators. Most
importantly, we have positioned ourselves with the latest technology and methodology to harness
cost effective strategies for start-up and small to mid-size partners. We offer an impressive solution
tailored to each client to maximize quality, efficiency, and support, without sacrificing responsiveness or
flexibility. Whether it's for a clinical trial, important post-marketing efforts, outcome registry, or
augmenting your staff, we bring a strong scientific and integrated approach that positions your research
strategy appropriately. By utilizing our collective knowledge and experience, we ensure our collaborators
achieve great success.
Biostatistical Synergy©
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EmpiriStat has collaborated with more than 30 clients in support of over 100 clinical trials since our
beginning in 2008. Our experience encompasses a full range of clinical trial management services from
early protocol development through post market surveillance. Our team has supported every stage of
drug and device development from bench to bedside. We are always looking to expand our knowledge
and apply our skill set to new areas as well.
Our Collaborators
Snapshot of our Industry, Government
and Academic Partners
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Government EmpiriStat works closely with government entities such as the United States Department of Defense
(DoD), the National Institutes of Health, and the United States Food and Drug Administration for such
tasks including:
Clinical Data Management
Biostatistics and Statistical Programming
Safety Monitoring and Reporting
Project Management
Regulatory Processes and Management of Investigational New Drug Applications (INDs)
Safety Monitoring and GCP Training
Providing Subject Matter Expertise in the development of Risk Based Monitoring Tools
Non-Profit Organizations
EmpiriStat works with non-profit organizations like the United Network for Organ Sharing (UNOS), The
Henry M. Jackson Foundation for the Advancement of Military Medicine and the United States
President's Emergency Plan for AIDS Relief (PEPFAR) performing such tasks as:
Design of domestic and international epidemiological studies
Health Survey and Questionnaire Design and implementation strategies
Process and management approach for effective data collection and statistical practices
Final statistical analyses for study reports and manuscripts
Scientific mentoring of scientists and validation procedures
Clinical Trial Training of clinicians, nurses and research staff in East and West Africa
Private Industry
EmpiriStat provides a wide range of services to private companies like Alexza Pharmaceuticals, Soluble
Systems, and Research & Diagnostic Antibodies including:
Consulting for integration of statistical analyses in FDA New Drug Applications (NDAs)
Grant writing and funding support
510(k) and PMA support
In-vitro device trial support
Validation of final statistical results for an Integrated Summary of Safety (ISS) and Integrated
Summary of Efficacy (ISE)
Providing management strategy and design methodology for clinical and health research
Design, management, and clinical monitoring of clinical studies
Academia and Private Practice
EmpiriStat collaborates with academic institutions like the Schulze Diabetes Institute at the University of
Minnesota and Coastal Carolinas Integrated Medicine on tasks including
Regulatory strategy for studies leading to a Biologics License Application (BLA) with the FDA
Clinical data management, project management, biostatistics and clinical monitoring
Clinical trial support and statistical analysis for IND studies
Grant writing support and strategy
Our Experience
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EmpiriStat is committed to providing the highest quality services, superior performance, and unmatched
customer accommodation. Every team member at EmpiriStat possesses a comprehensive knowledge of
regulatory affairs and applicable FDA and ICH guidances-- from our statistical and programming group,
to clinical data management to our clinical monitors.
It is our internal strengths, corporate structure and standard operating procedures, and most importantly
synergy as a team, that eliminates errors and redundancies that are not tolerable. Below we provide a
brief overview of our expertise, but highly recommend calling us to speak with us personally.
Biostatistics and Statistical Programming Our biostatistician’s provide statistical guidance on all clinical development program strategies,
development of optimal study designs, endpoint selection, sample size, randomization, blinding, and the
appropriate statistical methods for each design. They provide guidance on the selection of optimal
efficacy and safety endpoints and are particularly versed in various statistical methods, including what
may or may not be accepted for products and devices with the FDA. They know the importance of
planning for the collection of data, in terms of the study design and testing of the hypothesis(es). Sample
size and power calculations are devised based on previous literature, FDA expectations and guidelines,
and the appropriate statistical methodology chosen. We understand and are ready to recommend the
appropriate statistical techniques, even when those techniques may not be the “standard” for the field
currently or devise a mathematical approach to address that specific situation. We can cite the traditional
tests that we have experience in but our knowledge and the application of that knowledge is where we
excel.
We have served as presenting statisticians at the DSMB on behalf of the study and Sponsor, as well as the
DSMB statistician, and as the unblinded reporting statistician. We prepare all appropriate statistical
programming and reports based on our function, have a full understanding of the data, and can provide
quick analyses and reporting during the meeting if the Chair requires it. Any statistician that works in any
role of the DSMB is thoroughly versed in sequential monitoring techniques, understands the role of the
DSMB, is able to explain the statistical methodology of those sequential techniques, futility analyses,
statistical penalties for multiple looks at the data, and statistical justification for stopping early for
efficacy or safety.
In addition, we provide full CDISC implementation for your submissions through SDTM conversion and
ADaM datasets. We have internally implemented documented techniques that saves our collaborators
time during SDTM conversion, and have tips at the beginning of the studies on how some of our methods
can be adapted early in the process. It is never too early to have your ISS and ISE analyses and plans
developed to be implemented through your various phases as well.
It is our excellence in communication of statistical methodology, reasoning and presentation of analyses,
that has captured the interest of our clients. Our explanation to an investigator, interdisciplinary team,
Data and Safety Monitoring Board, or a lay person is made in a way for that concept to be understood.
We all consider ourselves at EmpiriStat constant learners, educators and mentors. If we cannot explain to
you why we should do something the way we propose, or give you options and the reasoning behind
those options, and you do not understand—that is our fault. It is our duty to teach, recommend and
learn.
Summary of Services
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Training An effective training plan is an essential requirement at the start of a study to deliver consistency
throughout the study by ensuring a uniform
interpretation of the study protocol, CRFs,
safety, and all study procedures. Our
training agenda’s include study-specific
training (protocol review and execution,
CRF training, safety) as well as general
clinical training (ICH/GCP, investigative
site expectations, and other key topics).
With EmpiriStat you get a team that is well
versed and experienced in preparing and
delivering training for clinical researchers.
We also provide Capacity Building for
research centers within and outside the
United States. The EmpiriStat Series 101
Training is comprised of a four day hands-
on course that provides participants the
background and essentials of Epidemiology, Clinical Data Management, Clinical Trial Foundations, and
Statistics for Non-Statisticians. Participants are able to receive a valuable education and the tools
necessary to design a clinical trial, generate data reports and provide scientific critique of research. The
course also teaches attendees how to develop work-plans and standard operating procedures to ensure the
safety of study subjects during a clinical trial.
Building from that solid knowledge base, we offer a Series 201 standard course as well. In this course,
the building blocks of Series 101 are emphasized, but
are expanded upon in Epidemiological
Investigations and Analyses, Advanced Topics in
Clinical Trials, Data Management Strategies and
Implications and Statistical Analyses and
Interpretation. Training methods are very important,
and as such we used didactic, hands on and small
group sessions using skills in these areas. Our
approach is through the use of slides and presentations,
group case studies, group discussion and exploration,
directed question and answer periods and summary
quizzes for the main topics of the day.
Our success in providing this training is evident in that
we have been a leading training provider to the President’s
Emergency Program for Aids Research (PEPFAR) and
have delivered countless training sessions in clinical research throughout Africa.
There are a number of clinical trial models that may be utilized within an organization and its
departments, between an organization and its subcontractors, and within a Clinical Research Network.
Regardless of the model employed, for clinical trials to be successful, there must be collaboration
amongst the stakeholders. There should be an examination of each group’s functional roles, an
understanding of the technical methods utilized as well as an appreciation of the behaviors, relationships
and values that enable an organization to carry out complex tasks.
We go anywhere in the world for you!
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Our Training Style
We understand that in the real world, personnel usually learn by seeing a problem, raising a question then
finding the answer. Our courses are structured in such a way that the material is taught in a purposeful,
sequential way, modeling after real world problem solving. Trainees will gain by the end of the course a
solid improvement/understanding, as a result of the learning activities, through the use of:
the use of slides and presentations
small group case study sessions on the topic area
individual work on a problem for resolution
group discussions and exploration
directed question and answer periods
summary quizzes of the main topics for the day
We also offer tailored training for our clients whether you want an on-site brown-bag training session or
an off-site training event at a designated site. Our training series and educational training modules
include Biostatistics, Data Management and Standards, Pharmacovigilence and Safety Reporting, Clinical
Monitoring and Data and Safety Monitoring Board Training.
Clinical Research Support Staffing
At EmpiriStat our staffing division focuses on providing clinical research professionals and expertise for
all therapeutic areas for products and devices. We serve the clinical research needs of our clients with
whom we partner. Our approach allows us to provide a wide range of tactical and experienced
professionals with strategic solutions to the primary challenges that our clients face.
Our approach is to listen, consult and partner with our clients.
We understand the criticality of selecting the right candidate for the right job, so we select each one
carefully. The first step in our recruiting process is identification of the appropriate skills sets, educational
and training background, and experience level required to perform each job. For each new requirement,
we consider the job duties and requirements, educational and training background needed, experience
level required, and any special skills necessary. Only through understanding our clients’ needs and careful
screening of candidates can we select the right person for each job. We consider factors such as the
desired salary range, the difficulty of finding the skills set, and the skills that are required versus the skills
that are helpful to have. Our staff carefully screens candidates’ qualifications as they relate to each client
through intense question and inquiry. This careful selection process leads to an increased level of client
satisfaction and project success.
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Risk Based Monitoring Tools
Risk based prioritization monitoring has changed the way we look at study management, monitoring and
statistical reporting. The first of two new draft guidance for industry, "Oversight of Clinical
Investigations— Risk-Based Approach to Monitoring" was released in August 2011. In conjunction with
this new guidance, the FDA will be describing a new review mechanism for monitoring Sponsors and
Clinical Research Organizations (CROs) during the IND application phase.
At EmpiriStat we understand and know how to implement the FDA guidances and at the same time
develop the steps to save a Sponsor time and resources during their clinical development program. A risk
based monitoring program provides the necessary risk assessment for clinical conduct and data collection
that applies available monitoring resources according to the identified risks – and reassesses those risks
on a regular basis throughout the study. Monitoring resources include Statistical Prioritization Reporting
as well as Regulatory Monitoring.
Sponsor Preventative Maintenance Program (SPMP)
Our Sponsor Preventative and Maintenance Program (SPMP), is a program in which we develop and
implement standard site metrics at the beginning of the IND phase for your clinical development program,
in preparation for NDA filing. We create Sponsor and site level Statistical Monitoring Reports with their
subsequent risk rankings to identify any clinical and logistical issues that will trigger possible GCP
question or concern, thus resulting in a higher probability of FDA inspection during your NDA
process. When applicable, our team works with the Sponsor to go out to the site to remedy and train on
identified issues.
EmpiriStat’s SPMP is an ongoing process; the metrics built will remain and will be automatically initiated
for all new studies and reports created for the Sponsor on a weekly, biweekly or monthly basis for
review. All reports are posted electronically to a Sponsor on a dedicated and secured file sharing system,
which the Sponsor controls on who receives access. Site Reports may also be sent and reviewed by our
team with your sites. We give comments and updates as needed on all reports.
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Challenge: A pharmaceutical company was only months away from filing their NA with the FDA.
They did not have an in-house Biostatistics/Statistical Programming group for review and writing of the
ISS SAP and to conduct validation programming for their program.
Solution: EmpiriStat collaborated with the company and provided all of the services required as the
Sponsor’s in-house Biostatistics and Statistical Programming group to support both the ISS and the NDA
filing within a very condensed timeframe without compromising quality.
Result: The Company received biostatistical guidance, writing, reviewing and statistical validation
programming from EmpiriStat to complete the filing within the existing company timelines. The
company saved time and money by consulting with EmpiriStat who provided flexible, time efficient and
cost effective services in an expedited manner set by the client’s needs.
Challenge: The client had contracted with EmpiriStat for part-time Senior Clinical and Regulatory
Affairs Management and expertise. The client was also in the process of contracting for a full service
CRO to provide Data Management, Clinical Monitoring, Safety Reporting, Biostatistics, and Regulatory
support for their multi-center clinical trial. However, the client was having contracting difficulties and
the trial timelines were being delayed.
Solution: EmpiriStat was contracted by client to expand their current services to provide a Bridge until
the CRO could be selected and contracted. In a condensed timeline of just 4 months, EmpiriStat created
the deliverables and provided the on-site professionals to initiate the clinical trial (including complete
Case Report Forms, Manual of Procedures, a Safety Reporting System, Study Specific Procedures for a
Data and Safety Monitoring Board, all training modules, Clinical Monitoring Plan and 2 certified research
coordinators and one professional consultant). A clear transition plan was developed between
EmpiriStat’s bridge of services to the CRO.
Result: The client moved forward with the deliverables required to initiate the trial without further delay,
had no cost or delay associated with a new group getting up to speed on the trial since EmpiriStat was
currently providing management guidance, and saved time and money when the CRO was hired since all
primary deliverables had been created for the study.
Challenge: A European device company was preparing for filing with the U.S. FDA with a device
already approved in Europe. They had consulted with an academic Biostatistician in the U.S., but were
unsure of the analyses and recommendations that the Biostatistician had made and was looking for an
independent opinion.
Solution: EmpiriStat was consulted to review the statistical analyses and recommendations and to
provide their own assessment prior to the company filing. EmpiriStat Principal Biostatistician, Dr. Nicole
C. Close, who has extensive U.S. Regulatory experience, along with an EmpiriStat Statistician located in
the United Kingdom who is well versed in EMEA guidance, reviewed the information and provided a
detailed Statistical Risk Analysis for the filing.
Result: The device company was provided with a detailed Statistical Risk Analysis summary and an
independent assessment. The company made modifications to their filing based on EmpiriStat’s
recommendations and successfully filed with the U.S. FDA.
Case Studies
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We at EmpiriStat are committed to building long lasting collaborative relationships with our clients. We
believe that to forge these effective relationships, we must remain true to our key values: responsibility,
integrity, value, and commitment to excellence in every task we undertake.
We bring the required knowledge and experience to your research and development, along with accurate
documentation, rigorous quality control, and regulatory compliance. We will work efficiently under your
tight project deadlines without compromising quality. Our goal is to ensure the highest statistical validity
through every project phase… as well as the ability to effectively communicate the results to a variety of
audiences.
EmpiriStat’s highly qualified staff includes Biostatisticians, Programmers, Regulatory Specialists, Project
Managers, Clinical Research Coordinators and Administrators, Quality Assurance Document Specialists,
and Data Managers, all led by our founder, Dr. Nicole Close, who is an experienced and trained
Biostatistician and Clinical Trialist.
Dr. Close is trained in Epidemiology and Biostatistics and has more than 16 years of professional
experience conduction and managing clinical trials and epidemiological research, including the
management of coordinating centers, and large-scale, multi-site data collection and statistical analysis
activities. Her passion for her field is expressed in the diligence and insightfulness she brings to each
project and therapeutic area. Dr. Close’s diverse background provides a solid foundation for EmpiriStat’s
corporate knowledge, supplemented by a team of highly trained colleagues in complementing areas of
expertise.
Our staff continuously seeks opportunities to interact with and educate professionals from many
disciplines, both in biostatistics and in methodological improvements that improve the outcomes and
enhance the knowledge gained from research.
VALUE BENEFITS
Experienced team successful in providing and
managing clinical research support
Understanding of needs and requirements ensures
that deliverables are managed on time, and within
budget
Flexibility EmpiriStat fits our resources to our collaborator’s
needs. This flexibility allows us to provide
solutions for any clinical research project
Understanding Clinical Trials In-depth understanding of the challenges faced
when managing and supporting clinical trials
Our Commitment
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I would do anything for EmpiriStat. You can trust them to do what
they say they will do, which isn’t always true about contractors. They
have a sense of urgency and their work is top-notch. The fact they are
a virtual company never entered my mind because they always
deliver—and in this economy, that is what it most important.
Roger House, President
Axiom Corporation
We asked Dr. Close to jump into a very specific role on a team already
moving at high speed toward an NDA. She did this quickly, ably and
cheerfully, and her work was integral to the submission. Her attention to
detail and process were particularly appreciated, and her collaborative
manner perfectly set the stage for a productive alliance.
Robert S. Fishman, MD, FCCP
VP, Clinical Development
Alexza Pharmaceuticals, Inc.
EmpiriStat runs a client-focused business with customer satisfaction
and quality of services as their top priorities. They serve as the
protocol statisticians for my research studies, participate in data safety
monitoring boards, and even developed a statistical capacity-building
workshop for the new researchers in Africa with whom I work. They
have a totally positive attitude—and are efficient, effective,
responsive, and flexible.
Dr. Judi Chamberlin
U.S. Military HIV Research Program
Kisumu, Kenya
The EmpiriStat team proved to be my closest collaborators on my research
grant proposal. They brought a precise knowledge of the grant review
process, study design, and power analysis. They were extremely helpful in
refining the study design to improve the statistical analysis. EmpiriStat
brought a genuine excitement about the science of our research and were
very easy to reach. They asked insightful questions and were very prompt
in their analysis and responses. It was a great pleasure to work with such
professionals."
Theodore Henderson, MD, PhD
The Synaptic Space
I’d heard EmpiriStat would be a good company to handle our
statistical analysis. They were very patient while we waited for
regulatory clearance, then incredibly fast and efficient when clearance
finally came. Their data cleaning was nothing short of amazing, and
when I asked them on short notice to write some abstracts for
conferences, I was blown away by how quickly this was done—and
they were extremely well-written. I can’t say anything bad about
EmpiriStat.
Mark Breda
Makerere University School of Medicine
Kampala, Uganda
You have a great programming team that is highly efficient and
communicates with ease. They do not sweat when the heat is on. They
were able to run with little direction and produce high quality outputs; a
nice group of “thinkers” not just “doers”. I am looking forward to
reviewing the datasets next week or this weekend. Our sponsor will be
excited/pleased to have the tight timeline delivered ahead of schedule.
Great work!”
Raven Quinn, MS
Biostatistician
Sarah Cannon Research Institute
You’re on the A list, but we haven’t finalized the clinical studies
budget for 2010. You may safely assume we’ll call you when we
ramp up. Your supervision and back-up on the mechanics of our
programming and data management was incredibly helpful in ’09.
Robert S. Fishman, MD, FCCP
VP, Clinical Development
Alexza Pharmaceuticals, Inc.
One of the great characteristics Dr. Close brought to our projects was her
great investment in ensuring the integrity of our data. Her respect for both
our data and our study goals was a primary factor in our success. Dr. Close
was remarkably thorough in the processes she brought to managing data as
well as in the analytic programming she created for us.
Dr. Bob O’Brien
The CDM Group, Inc.
The auditors were really nice and easy to work with and made the
process very painless!
Sandra M. Berney, RN, ASN, CCTC
St. Vincent Indianapolis Hospital
Good job on getting all of the reports turned around so quickly. I am sure
UAB is very, very happy.
Amy Putnam
Survey Services Manager
UNOS Department of Evaluation and Quality
Thank you so much for all of EmpiriStat’s knowledge and effort. I
consider myself lucky to be working with you!
Mike Webber
Soluble Systems
I wanted to thank you again for the great support of Cerescan…they were
VERY impressed (and so was I!...)
M. Veatch
Quintiles
Testimonials
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Nicole C. Close, PhD
President and Principal Biostatistician
13694 Sam Hill Drive
Mount Airy, Maryland USA 21771
(TF) 866-935-7828 (x 703)
(T) 240-744-0000 (x703)
(F) 866-276-7828
Caylee A. Ortega
Chief Operating Officer/Director of Business Development
13694 Sam Hill Drive
Mount Airy, Maryland USA 21771
(TF) 866-935-7828 (x 702)
(T) 240-744-0000 (x702)
(F) 866-276-7828
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