2012 2013 Corporate Capabilities

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2012 2013 Corporate Capabilities

  1. 1. 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 
  2. 2. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Corporate SummaryAt EmpiriStat our work lies at the intersection of science and practice, in collaboration with partners forthe design, implementation and analysis of clinical trials and research studies. With our in-depthbiostatistical and methodological experience, we navigate through the myriad of regulations and researchguidelines 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. Weoperate 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 andfull Phase I to IV clinical support, with post marketing analysis throughout a wide range of therapeuticareas and devices. We offer a variety of customizable services of high-end development and knowledgein: Biostatistics and Statistical Programming Risk Based Monitoring Regulatory planning, support & submission Epidemiological Cohort and Longitudinal for INDs, BLAs, PMA, 510ks, and IDEs Studies Data and Safety Monitoring Board services Capacity Building Training for Existing and (masked and unmasked statistical support), Developing Programs Charter Services and Administrative Duties Clinical Research Support Staffing for Clinical Data Management support Government and IndustryEmpiriStat’s founder Dr. Nicole C. Close wasn’t satisfied to cruise the easy road, she has continuallychallenged herself and those around her. Under the guidance of mentors she was encouraged to thinkbeyond boundaries. This no-limits approach became a unique part of her professional methodology. InMarch 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 developmentoptions while delivering the highest quality product. Responsibility to each other and to our clients isour 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 Quick Facts with a powerful team of subject matter experts in scientific, regulatory, and logistical aspects of clinical Woman-Owned Small Business research, EmpiriStat has the ability to understand our CAGE Code: 53F97 clients goals and provide the necessary contributions required to achieve them. Driven by our passion for DUNS Number: 826391034 science and overcoming the challenges associated with Small Business NAICS 518210, research, we can confidently state that our clients’ 541519, 541611, 541690, 541712, success is our success. We genuinely care about our collaborators. We get to 541720, 541990, 611420, 611430 know them, their families, their hobbies and we share FWA 00015488 with them as well. It’s the personal attributes of our Navy FWA Addendum team that makes us easy to work with and our passion and excitement for science and research is evident in all Air Force FWA Addendum we do.2|P age
  3. 3. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Why EmpiriStat 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, DC3|P age
  4. 4. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Biostatistical Synergy©It takes a team approach for the successful completion of a research study or for the development of anew 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 mustbe able to effectively orchestrate these complex tasks.EmpiriStat has collaborated with clients and organizations in almost every industry and specialty—bothin the U.S. and countries around the world. We have developed and refined a rigorous, effectivefoundation of methodologies that are fluid yet repeatable—enabling us to quickly adapt to each newproject and provide the high level of personal service and reliability that is the core of our reputation. EmpiriStats Methodologies Adapt to Every Industry and TherapeuticMore and more pharmaceutical and biotech companies are strategically outsourcing their developmentneeds to CRO partners that have exceptional skills in defined areas. As a result, the role of the CRO as aservice provider is rapidly changing. Companies are now moving toward a strategic outsourcing modelto maximize clinical development efficiencies and product quality. And as industry diversifies, EmpiriStatis 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 havesuccessfully and seamlessly integrated into our collaborators development programs, not only byproviding operational support and services, but by providing strategic insight into the unique clinicaldevelopment challenges.EmpiriStat, Inc. is ideally positioned to provide the most value to our collaborators. Mostimportantly, we have positioned ourselves with the latest technology and methodology to harnesscost effective strategies for start-up and small to mid-size partners. We offer an impressive solutiontailored to each client to maximize quality, efficiency, and support, without sacrificing responsiveness orflexibility. Whether its for a clinical trial, important post-marketing efforts, outcome registry, oraugmenting your staff, we bring a strong scientific and integrated approach that positions your researchstrategy appropriately. By utilizing our collective knowledge and experience, we ensure our collaboratorsachieve great success.4|P age
  5. 5. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Our CollaboratorsEmpiriStat has collaborated with more than 30 clients in support of over 100 clinical trials since ourbeginning in 2008. Our experience encompasses a full range of clinical trial management services fromearly protocol development through post market surveillance. Our team has supported every stage ofdrug and device development from bench to bedside. We are always looking to expand our knowledgeand apply our skill set to new areas as well. Snapshot of our Industry, Government and Academic Partners5|P age
  6. 6. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Our ExperienceGovernmentEmpiriStat 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 suchtasks 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 ToolsNon-Profit OrganizationsEmpiriStat works with non-profit organizations like the United Network for Organ Sharing (UNOS), TheHenry M. Jackson Foundation for the Advancement of Military Medicine and the United StatesPresidents 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 AfricaPrivate IndustryEmpiriStat provides a wide range of services to private companies like Alexza Pharmaceuticals, SolubleSystems, 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 studiesAcademia and Private PracticeEmpiriStat collaborates with academic institutions like the Schulze Diabetes Institute at the University ofMinnesota 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 strategy6|P age
  7. 7. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Summary of ServicesEmpiriStat is committed to providing the highest quality services, superior performance, and unmatchedcustomer accommodation. Every team member at EmpiriStat possesses a comprehensive knowledge ofregulatory 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 importantlysynergy as a team, that eliminates errors and redundancies that are not tolerable. Below we provide abrief overview of our expertise, but highly recommend calling us to speak with us personally.Biostatistics and Statistical ProgrammingOur biostatistician’s provide statistical guidance on all clinical development program strategies,development of optimal study designs, endpoint selection, sample size, randomization, blinding, and theappropriate statistical methods for each design. They provide guidance on the selection of optimalefficacy and safety endpoints and are particularly versed in various statistical methods, including whatmay or may not be accepted for products and devices with the FDA. They know the importance ofplanning for the collection of data, in terms of the study design and testing of the hypothesis(es). Samplesize 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 theappropriate statistical techniques, even when those techniques may not be the “standard” for the fieldcurrently or devise a mathematical approach to address that specific situation. We can cite the traditionaltests that we have experience in but our knowledge and the application of that knowledge is where weexcel.We have served as presenting statisticians at the DSMB on behalf of the study and Sponsor, as well as theDSMB statistician, and as the unblinded reporting statistician. We prepare all appropriate statisticalprogramming and reports based on our function, have a full understanding of the data, and can providequick analyses and reporting during the meeting if the Chair requires it. Any statistician that works in anyrole of the DSMB is thoroughly versed in sequential monitoring techniques, understands the role of theDSMB, 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 forefficacy or safety.In addition, we provide full CDISC implementation for your submissions through SDTM conversion andADaM datasets. We have internally implemented documented techniques that saves our collaboratorstime during SDTM conversion, and have tips at the beginning of the studies on how some of our methodscan be adapted early in the process. It is never too early to have your ISS and ISE analyses and plansdeveloped 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 toyou why we should do something the way we propose, or give you options and the reasoning behindthose options, and you do not understand—that is our fault. It is our duty to teach, recommend andlearn.7|P age
  8. 8. EmpiriStat, Inc.2012-2013 Corporate Capabilities BriefTrainingAn 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 thebackground and essentials of Epidemiology, Clinical Data Management, Clinical Trial Foundations, andStatistics for Non-Statisticians. Participants are able to receive a valuable education and the toolsnecessary to design a clinical trial, generate data reports and provide scientific critique of research. Thecourse also teaches attendees how to develop work-plans and standard operating procedures to ensure thesafety 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, butare expanded upon in EpidemiologicalInvestigations and Analyses, Advanced Topics inClinical Trials, Data Management Strategies andImplications and Statistical Analyses andInterpretation. Training methods are very important,and as such we used didactic, hands on and smallgroup sessions using skills in these areas. Ourapproach is through the use of slides and presentations,group case studies, group discussion and exploration,directed question and answer periods and summaryquizzes for the main topics of the day.Our success in providing this training is evident in thatwe have been a leading training provider to the President’s We go anywhere in the world for you!Emergency Program for Aids Research (PEPFAR) andhave 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 itsdepartments, 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 collaborationamongst the stakeholders. There should be an examination of each group’s functional roles, anunderstanding of the technical methods utilized as well as an appreciation of the behaviors, relationshipsand values that enable an organization to carry out complex tasks.8|P age
  9. 9. EmpiriStat, Inc.2012-2013 Corporate Capabilities BriefOur Training StyleWe understand that in the real world, personnel usually learn by seeing a problem, raising a question thenfinding 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 asolid 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 dayWe also offer tailored training for our clients whether you want an on-site brown-bag training session oran off-site training event at a designated site. Our training series and educational training modulesinclude Biostatistics, Data Management and Standards, Pharmacovigilence and Safety Reporting, ClinicalMonitoring and Data and Safety Monitoring Board Training.Clinical Research Support StaffingAt EmpiriStat our staffing division focuses on providing clinical research professionals and expertise forall therapeutic areas for products and devices. We serve the clinical research needs of our clients withwhom we partner. Our approach allows us to provide a wide range of tactical and experiencedprofessionals 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 onecarefully. The first step in our recruiting process is identification of the appropriate skills sets, educationaland 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, experiencelevel required, and any special skills necessary. Only through understanding our clients’ needs and carefulscreening of candidates can we select the right person for each job. We consider factors such as thedesired salary range, the difficulty of finding the skills set, and the skills that are required versus the skillsthat are helpful to have. Our staff carefully screens candidates’ qualifications as they relate to each clientthrough intense question and inquiry. This careful selection process leads to an increased level of clientsatisfaction and project success.9|P age
  10. 10. EmpiriStat, Inc.2012-2013 Corporate Capabilities BriefRisk Based Monitoring ToolsRisk based prioritization monitoring has changed the way we look at study management, monitoring andstatistical reporting. The first of two new draft guidance for industry, "Oversight of ClinicalInvestigations— Risk-Based Approach to Monitoring" was released in August 2011. In conjunction withthis new guidance, the FDA will be describing a new review mechanism for monitoring Sponsors andClinical Research Organizations (CROs) during the IND application phase.At EmpiriStat we understand and know how to implement the FDA guidances and at the same timedevelop the steps to save a Sponsor time and resources during their clinical development program. A riskbased monitoring program provides the necessary risk assessment for clinical conduct and data collectionthat applies available monitoring resources according to the identified risks – and reassesses those riskson a regular basis throughout the study. Monitoring resources include Statistical Prioritization Reportingas well as Regulatory Monitoring.Sponsor Preventative Maintenance Program (SPMP)Our Sponsor Preventative and Maintenance Program (SPMP), is a program in which we develop andimplement 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 theirsubsequent risk rankings to identify any clinical and logistical issues that will trigger possible GCPquestion or concern, thus resulting in a higher probability of FDA inspection during your NDAprocess. When applicable, our team works with the Sponsor to go out to the site to remedy and train onidentified issues.EmpiriStat’s SPMP is an ongoing process; the metrics built will remain and will be automatically initiatedfor all new studies and reports created for the Sponsor on a weekly, biweekly or monthly basis forreview. 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 ourteam with your sites. We give comments and updates as needed on all reports.10 | P a g e
  11. 11. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Case StudiesChallenge: 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 theISS SAP and to conduct validation programming for their program.Solution: EmpiriStat collaborated with the company and provided all of the services required as theSponsor’s in-house Biostatistics and Statistical Programming group to support both the ISS and the NDAfiling within a very condensed timeframe without compromising quality.Result: The Company received biostatistical guidance, writing, reviewing and statistical validationprogramming from EmpiriStat to complete the filing within the existing company timelines. Thecompany saved time and money by consulting with EmpiriStat who provided flexible, time efficient andcost 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 RegulatoryAffairs Management and expertise. The client was also in the process of contracting for a full serviceCRO to provide Data Management, Clinical Monitoring, Safety Reporting, Biostatistics, and Regulatorysupport for their multi-center clinical trial. However, the client was having contracting difficulties andthe trial timelines were being delayed.Solution: EmpiriStat was contracted by client to expand their current services to provide a Bridge untilthe CRO could be selected and contracted. In a condensed timeline of just 4 months, EmpiriStat createdthe deliverables and provided the on-site professionals to initiate the clinical trial (including completeCase Report Forms, Manual of Procedures, a Safety Reporting System, Study Specific Procedures for aData and Safety Monitoring Board, all training modules, Clinical Monitoring Plan and 2 certified researchcoordinators and one professional consultant). A clear transition plan was developed betweenEmpiriStat’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 wascurrently providing management guidance, and saved time and money when the CRO was hired since allprimary deliverables had been created for the study.Challenge: A European device company was preparing for filing with the U.S. FDA with a devicealready approved in Europe. They had consulted with an academic Biostatistician in the U.S., but wereunsure of the analyses and recommendations that the Biostatistician had made and was looking for anindependent opinion.Solution: EmpiriStat was consulted to review the statistical analyses and recommendations and toprovide their own assessment prior to the company filing. EmpiriStat Principal Biostatistician, Dr. NicoleC. Close, who has extensive U.S. Regulatory experience, along with an EmpiriStat Statistician located inthe United Kingdom who is well versed in EMEA guidance, reviewed the information and provided adetailed Statistical Risk Analysis for the filing.Result: The device company was provided with a detailed Statistical Risk Analysis summary and anindependent assessment. The company made modifications to their filing based on EmpiriStat’srecommendations and successfully filed with the U.S. FDA.11 | P a g e
  12. 12. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Our CommitmentWe at EmpiriStat are committed to building long lasting collaborative relationships with our clients. Webelieve 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 accuratedocumentation, rigorous quality control, and regulatory compliance. We will work efficiently under yourtight project deadlines without compromising quality. Our goal is to ensure the highest statistical validitythrough every project phase… as well as the ability to effectively communicate the results to a variety ofaudiences.EmpiriStat’s highly qualified staff includes Biostatisticians, Programmers, Regulatory Specialists, ProjectManagers, 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 trainedBiostatistician and Clinical Trialist.Dr. Close is trained in Epidemiology and Biostatistics and has more than 16 years of professionalexperience conduction and managing clinical trials and epidemiological research, including themanagement of coordinating centers, and large-scale, multi-site data collection and statistical analysisactivities. Her passion for her field is expressed in the diligence and insightfulness she brings to eachproject and therapeutic area. Dr. Close’s diverse background provides a solid foundation for EmpiriStat’scorporate knowledge, supplemented by a team of highly trained colleagues in complementing areas ofexpertise.Our staff continuously seeks opportunities to interact with and educate professionals from manydisciplines, both in biostatistics and in methodological improvements that improve the outcomes andenhance the knowledge gained from research. VALUE BENEFITSExperienced team successful in providing and Understanding of needs and requirements ensuresmanaging clinical research support that deliverables are managed on time, and within budgetFlexibility EmpiriStat fits our resources to our collaborator’s needs. This flexibility allows us to provide solutions for any clinical research projectUnderstanding Clinical Trials In-depth understanding of the challenges faced when managing and supporting clinical trials12 | P a g e
  13. 13. EmpiriStat, Inc. 2012-2013 Corporate Capabilities Brief TestimonialsI would do anything for EmpiriStat. You can trust them to do what We asked Dr. Close to jump into a very specific role on a team alreadythey say they will do, which isn’t always true about contractors. They moving at high speed toward an NDA. She did this quickly, ably andhave a sense of urgency and their work is top-notch. The fact they are cheerfully, and her work was integral to the submission. Her attention toa virtual company never entered my mind because they always detail and process were particularly appreciated, and her collaborativedeliver—and in this economy, that is what it most important. manner perfectly set the stage for a productive alliance.Roger House, President Robert S. Fishman, MD, FCCPAxiom Corporation VP, Clinical Development Alexza Pharmaceuticals, Inc.EmpiriStat runs a client-focused business with customer satisfaction The EmpiriStat team proved to be my closest collaborators on my researchand quality of services as their top priorities. They serve as the grant proposal. They brought a precise knowledge of the grant reviewprotocol statisticians for my research studies, participate in data safety process, study design, and power analysis. They were extremely helpful inmonitoring boards, and even developed a statistical capacity-building refining the study design to improve the statistical analysis. EmpiriStatworkshop for the new researchers in Africa with whom I work. They brought a genuine excitement about the science of our research and werehave a totally positive attitude—and are efficient, effective, very easy to reach. They asked insightful questions and were very promptresponsive, and flexible. in their analysis and responses. It was a great pleasure to work with such professionals."Dr. Judi ChamberlinU.S. Military HIV Research Program Theodore Henderson, MD, PhDKisumu, Kenya The Synaptic SpaceI’d heard EmpiriStat would be a good company to handle our You have a great programming team that is highly efficient andstatistical analysis. They were very patient while we waited for communicates with ease. They do not sweat when the heat is on. Theyregulatory clearance, then incredibly fast and efficient when clearance were able to run with little direction and produce high quality outputs; afinally came. Their data cleaning was nothing short of amazing, and nice group of “thinkers” not just “doers”. I am looking forward towhen I asked them on short notice to write some abstracts for reviewing the datasets next week or this weekend. Our sponsor will beconferences, I was blown away by how quickly this was done—and excited/pleased to have the tight timeline delivered ahead of schedule.they were extremely well-written. I can’t say anything bad about Great work!”EmpiriStat. Raven Quinn, MSMark Breda BiostatisticianMakerere University School of Medicine Sarah Cannon Research InstituteKampala, UgandaYou’re on the A list, but we haven’t finalized the clinical studies One of the great characteristics Dr. Close brought to our projects was herbudget for 2010. You may safely assume we’ll call you when we great investment in ensuring the integrity of our data. Her respect for bothramp up. Your supervision and back-up on the mechanics of our our data and our study goals was a primary factor in our success. Dr. Closeprogramming and data management was incredibly helpful in ’09. was remarkably thorough in the processes she brought to managing data as well as in the analytic programming she created for us.Robert S. Fishman, MD, FCCPVP, Clinical Development Dr. Bob O’BrienAlexza Pharmaceuticals, Inc. The CDM Group, Inc.The auditors were really nice and easy to work with and made the Good job on getting all of the reports turned around so quickly. I am sureprocess very painless! UAB is very, very happy.Sandra M. Berney, RN, ASN, CCTC Amy PutnamSt. Vincent Indianapolis Hospital Survey Services Manager UNOS Department of Evaluation and QualityThank you so much for all of EmpiriStat’s knowledge and effort. I I wanted to thank you again for the great support of Cerescan…they wereconsider myself lucky to be working with you! VERY impressed (and so was I!...)Mike Webber M. VeatchSoluble Systems Quintiles 13 | P a g e
  14. 14. EmpiriStat, Inc.2012-2013 Corporate Capabilities Brief Contact UsNicole C. Close, PhDPresident and Principal Biostatistician13694 Sam Hill DriveMount Airy, Maryland USA 21771(TF) 866-935-7828 (x 703)(T) 240-744-0000 (x703)(F) 866-276-7828nclose@empiristat.comCaylee A. OrtegaChief Operating Officer/Director of Business Development13694 Sam Hill DriveMount Airy, Maryland USA 21771(TF) 866-935-7828 (x 702)(T) 240-744-0000 (x702)(F) 866-276-7828cortega@empiristat.com14 | P a g e

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