EmpiriStat Corporate Capabilities 2011
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    EmpiriStat Corporate Capabilities 2011 EmpiriStat Corporate Capabilities 2011 Document Transcript

    • REACH CLOSER to the Truth EmpiriStat, Inc.2011 Corporate Capabilities Summary BIOSTATISTICAL SYNERGY 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  [1]
    • Corporate Capabilities Summary REACH CLOSER to the Truth Quick Facts About EmpiriStat, Inc. Woman-Owned Small EmpiriStat was founded with a unique goal: to discover the truth as far as Business possible. As biostatisticians and clinical trialists, we believe reaching this goal is only possible by going beyond analytics. For every research and development Federalwide Assurance (FWA) A00015488 project, science and fact extend along a timeline in both directions—past, present and future. Applying rigorous methodologies and experience at every CAGE Code: 53F97 point along this timeline results in outcomes that are as close to the truth as DUNS Number: 826391034 possible. Small Business NAICS codes: 518210 541519 541611 Our work lies at the intersection of science and practice. We bring in depth 541690 541712 541720 experience to your research and development, along with accurate 541990 611420 611430 documentation, rigorous quality control, and regulatory compliance. We work efficiently under tight project deadlines without compromising quality. EmpiriStat, Inc. Professional Development and Training We work with clients interested in ongoing communication and dialogueEducation and training is the between disciplines and our experience comes from collaborating with manycornerstone of EmpiriStat. researchers over a wide range and complexity of studies in epidemiology andWithout the tools for continuous various medical and device specialties. We are committed to providing andimprovement professionally and maintaining the highest scientific rigor and ethical standards—while providingpersonally, we believe we lose both timely and cost-effective services.the insight, knowledge, andpassion to further ourselves,our career, and our business. Commitment to ExcellenceTraining is the process of We at EmpiriStat are committed to “We have the passion for makingdeveloping specific skills to building long lasting collaborative things happen with an urgentperform a certain job or task relationships with our clients. We believemore efficiently, and education patience, optimism, and a tolerance that to forge these effective relationships,is noted to be the overall we must remain true to our key values: for uncertainty. It is not just thedevelopment of the human responsibility, integrity, value, and respect for our knowledge in themind. EmpiriStat offers a wide commitment to excellence in every role field that we possess, but takingrange of specific trainingsessions, such as Good Clinical and task we undertake. action and doing valuable workPractice (GCP) training, Site with that knowledge.”Management Training, or Data Our underlying foundation at EmpiriStat isand Safety Monitoring Board a belief that we can make a difference in ~ Dr. Nicole C. Close, President(DSMB) Training. We also offer the world and we will try to do that eacha wide variety of Professional and every day. We have the passion forDevelopment courses, such as making things happen, coupled with a genuine reserve of good will, fromEducational Modules in professionals who are excited to share and contribute their knowledge andBiostatistics for Non- experience, but who are equally compelled to learn and to engage themselvesStatisticians, Epidemiology, in that process to continually improve corporately, professionally andData Management, andPharmacovigilance. Please personally.contact us to request aProfessional Development andTraining Brochure. 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]
    • SELECTED CASE STUDIES ServicesChallenge: A pharmaceutical We offer the following major clinical research collaboration and services:company was only months away Biostatistics and Statistical Programmingfrom filing their NDA with the Data and Safety Monitoring Board ServicesFDA. They did not have an in- Project Managementhouse Biostatistics/StatisticalProgramming group for review Statistical Software and Programming Validationand writing of the ISS SAP and Clinical Data Managementto conduct the validation Clinical Site Managementprogramming for their program. Clinical Monitoring Services Safety Monitoring and Reporting ServicesStatistical Analysis: EmpiriStatcollaborated with the company Regulatory Support Servicesand provided all of the services Scientific Administrative Supportrequired as the Sponsor’s in- Biostatistical Synergyhouse Biostatistics and StatisticalProgramming group to supportboth the ISS and the NDA filingwithin a very condensed Biostatistics and Statistical Programmingtimeframe without compromising EmpiriStat provides a wide range of services throughout every project andquality. clinical trial phase. Some services – such as statistical programming of tables, listings, and figure shells – provide cost and time savings to our collaborator ifResult: The company receivedthe Biostatistical guidance, programmed and validated while the trial iswriting, review and statistical ongoing (instead of during the database closure andvalidation programming from analysis phase). The range of our assistance can beEmpiriStat to complete the filing categorized loosely by project/trial phasewithin the existing company (Implementation, Ongoing, Database Closure,timelines. The company saved Analysis, Post Clinical Trial, and General) and rangetime and money by consulting from hypothesis, objectives and endpoint planning, Protocol and Statisticalwith EmpiriStat who provided Analysis Plan writing/review, Sample size/power calculations, Statisticalflexible, time efficient and cost programming specifications, to Interim data monitoring/analysis, Databaseeffective services in an expedited review and cleaning, and Primary statistical analysis and secondary review ofmanner set by the client’s needs. statistical analysis and interpretation.Challenge: The client hadcontracted with EmpiriStat for Data and Safety Monitoring Board Servicespart-time Senior Clinical and Establishing, managing, and participating on a Data and Safety MonitoringRegulatory Affairs Management Board (DSMB) is a serious process. EmpiriStat has the skills, knowledge, andand expertise. The client was experience to perform DSMB services professionally and effectively. As aalso in the process of contracting partner in the process, we assist the Sponsor in DSMB member identificationfor a full service CRO to provide and selection, DSMB training, and full administrative support services. OurData Management, Clinical professional management and secure data analysis and delivery ensuresMonitoring, Safety Reporting, leadership to assist with establishing the objectives, responsibilities, andBiostatistics, and Regulatory procedures through an official charter. We also have the expertise to establishsupport for their multi-centerclinical trial. However, the client procedures for the review of safety data, and we are fully qualified to act aswas having contracting the unblinded partner in performing the statistical analysis and facilitation ofdifficulties and the trial timelines the exchange of information between the DSMB members, DSMB Chair, andwere being delayed. Sponsor.Solution: EmpiriStat wascontracted by the client toexpand their current services toprovide a Bridge until the CROcould be selected andcontracted. In a condensed 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  [3]
    • timeline of just 4 months,EmpiriStat created the Project Managementdeliverables and provided the EmpiriStat has the experience and capability to succeed at collaborating andon-site professionals to initiate managing overall projects and clinical trials beyond statistical services. Wethe clinical trial (including have the ability to provide critical leadership across the entire project team,complete Case Report Forms, and we work with the sponsor to complete deliverables and strive to meetManual of Procedures, a Safety project timelines and budget specifications. Our Project Management supportReporting System, Study Specific will guide your study with seamless communication that will define andProcedures, Establishment and complete your project on time, and on budget. Some of our PM services canprocedures for a Data and Safety include “hands-on” oversight from concept to completion, coordination andMonitoring Board, all training review of project deliverables such as Protocols, CRFs, and other clinical studymodules, Clinical Monitoring Planand 2 certified research tools, and study budget forecasting and contract negotiation. We also developcoordinators and one Risk Analysis Plans, Outsourcing Plans, and Contingency Plans to reach yourprofessional consultant). A clear project milestones.transition plan was developedbetween EmpiriStat’s Bridge of Statistical Software and Programming Validationservices to the CRO. Validation is a critical element in clinical trials, and EmpiriStat providesResult: The client moved valuable insight for the entire validation process, including assistance withforward with the deliverables validation procedures and documentation of statistical software installation,required to initiate the trial operation and performance qualification, SAS® Macro and statisticalwithout further delay, had no programming validation, and independent review and assessment of corporatecost or delay associated with anew group getting up to speed statistical software validation procedures, processes and documentation.on the trial since EmpiriStat wascurrently providing management Clinical Data Managementguidance. It saved time and Effective and well-executed data management is a vital part of any project ormoney when the CRO was hiredsince all primary deliverables had clinical trial, and EmpiriStat’s Data Management servicesbeen created for the study. ensure the quality of your results. EmpiriStat is capable of providing full data management services to include the design and review of case report forms, DataChallenge: A European device Management Plans, and the development of editcompany was preparing for filing specifications. We also have the ability to develop andwith the US FDA with a device implement a clinical database to collect and store study data, and performalready approved in Europe. medical coding using MedDRA and WHO Drug dictionaries. EmpiriStat is proudThey had consulted with an to be capable of supporting studies that are paper-based, electronic, or aacademic Biostatistician in the hybrid of both.US, but were unsure of theanalyses and recommendationsthat the Biostatistician had made Clinical Site Managementand was looking for an Selection, evaluation and qualification of clinical sites and investigators areindependent senior statistical critical for the successful execution and completion of clinical trials. The siteopinion. selection process and the relationship of the sponsor-site-investigator are keySolution: EmpiriStat was areas of opportunity in accelerating the drug and device development processconsulted to review the while generating high quality data. Site selection is a crucial decision thatstatistical analyses and needs to be made by the Sponsor in which both obvious and underlyingrecommendations and to provide challenges are addressed and efficiencies are made. Considerations we taketheir own assessment prior tothe company filing. EmpiriStat into account are the potential of patient recruitment and retention; thestatisticians (PhD Biostatistician experience of the site Principal Investigator, quicker start-up processes, thewith US Regulatory experience increased competition among Sponsors for sites, patients, increasedand an EmpiriStat UK Statistical globalization of trials and key players, and FDA and international regulations.Consultants versed in EMEA EmpiriStat assists the Sponsor in creating site selection and managementguidances) reviewed the processes by taking an in-depth look at specific steps and/or a critical analysisinformation and provided a of existing practices, challenges and provide an opportunity to formulate a 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  [4]
    • detailed Statistical Risk Analysis more solid partnership between Sponsors, sites and investigators.of the filing.Result: The device company Our team has successfully implemented clinical trial sites, and we have provenwas provided with a detailed processes for starting new sites that remain lasting ones through in-depthStatistical Risk Analysis training, education and continual mentoring.summary and an independentassessment. The company mademodifications to their filing based Clinical Monitoring Servicesupon EmpiriStat’s Frontline attention to detail and quality comes from well-developed clinicalrecommendations and monitoring plans and their appropriate execution. EmpiriStat embraces thesuccessfully filed with the US philosophy that the biostatistician and data manager works with the clinicalFDA. monitor in those plans in order to provide insight into key variables and issues of data collection and recording that may have an impact on the final analyses. Early identification prevents issues later and saves staff time and costs. We Therapeutic Experience assist our collaborators with expertise in quality assurance of study operations, writing and implementing clinical monitoring plans, monitoring reports, as well  Infectious Diseases  Vaccines as protocol and regulatory compliance review.  Traumatic Brain Injury It’s our standard to have a very short turnaround time for issuing our reports.  Transplants and Immunology Something we take great pride in and have been commended on by many of  Anti-Infectives our clients.  Reproductive Health  Medical Devices  Dermatology Safety Monitoring and Reporting Services  Blood Products EmpiriStat offers a comprehensive plan to help you manage your pre- and  Wound Care post-marketed product safety program. This management and services may  Oncology  Diabetes include Serious Adverse Event (SAE) and Adverse Event (AE) reporting, SAE and  Cardiovascular Disease AE MedDRA coding, examining current treatment utilization patterns, SAE narrative writing, submission to regulatory authorities, generation of MedWatch (3500A/CIOMS) Forms, preparation of periodic safety updateGlobal Depth and Diversity reports (PSURs) and periodic adverse drug experience reports (PADERs. We follow the FDAs Good Pharmacovigiliance Practices and EMEAs European  Government Directive 2001/20/EC guidelines and focus our work-products on the end-user  Non Profit Organizations perspective.  Private Industry For those studies that require use of an Independent Safety Monitor, our  Academic EmpiriStat Consultants stand ready to perform those functions as well, safely partitioned and fire-walled from our Safety Department and project staff.  Private Practices Regulatory Support Services“I would do anything for Empiristat. You EmpiriStat offers tailor made regulatory services to assists Sponsors andcan trust them to do what they say they Investigators with the administrative activities involved in meeting thewill do, which isn’t always true aboutcontractors. They have a sense of regulatory requirements for research involving human subjects. We canurgency and their work is top-notch. assure that study projects and protocols comply with federal, state, andThe fact they are a virtual company institutional requirements governing the conduct and implementation of eachnever entered my mind because they trial, and can serve as a liaison between the FDA, the IRB, Investigators, andalways deliver—and in this economy, Research Staff. Additionally, we can offer consultation and guidance regardingthat is what it most important.” the application to the FDA regarding your product or device, support for FDA and IRB submissions, assistance with registering trials on ClinicalTrials.gov,~Roger House, President assistance with Pre-IND meetings, Type B Meetings and other regulatedAxiom Corporation meeting requests, and guidance for FDA audits. 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  [5]
    • Scientific Administrative Support Often it is necessary to provide scientific administrative support for a project that may not have a dedicated individual to perform these services, or does not have a sufficient amount of this work to employ a full-time staff member to handle. This often results in these services being assigned to members of the team with other duties. With competing projects, timelines, and efficiency in mind, EmpiriStat recognizes these challenges and provides the following services to support your team: Administrative management of Data and Safety Monitoring Boards, preparation and distribution of paper and electronic documents, on-site management of local or international conferences, andFor personalized attention coordination of Investigator kick-off meetings. Also provided are the contact us at: coordination and scheduling of science team meetings, and taking minutes during these group collaborations. EmpiriStat, Inc. 13694 Sam Hill Drive Mount Airy, MD 21771 Biostatistical Synergy Tel: 866.935.STAT derived from the Greek synergos, συνεργός meaning working together Fax: 866.276.STAT Email: info@empiristat.com Synergy is when two or more different entities cooperate advantageously for a final outcome. We think with EmpiriStat’s teamwork, we will help you produce an overall better result than if you were working toward the same goal individually. We take pride in our ability to provide the highest quality services with an appropriately staffed team while maintaining our responsiveness and flexibility of a smaller company. It’s a promised standard from us that includes expertise, mentoring, and support from a team of experts who understand your needs. Our goal is always to help you succeed by working as a part of your team. We will tailor a project plan to meet the needs www.empiristat.com of every project, whether you need full scope global services or only one particular service, such as statistical analysis and programming. It is our absolute goal to help you succeed by fully integrating and working as part of your team. “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 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  [6]