2010 Empiri Stat Corporate Capabilities


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2010 Empiri Stat Corporate Capabilities

  1. 1. REACH CLOSER to the Truth EmpiriStat, Inc. 2010 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
  2. 2. Corporate Capabilities Summary REACH CLOSER to the Truth Quick Facts About EmpiriStat 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 project, science and fact extend along a timeline in both directions—past, Federalwide Assurance present and future. Applying rigorous methodologies and experience at every (FWA) A00015488 point along this timeline results in outcomes that are as close to the truth as possible. CAGE Code: 53F97 Our work lies at the intersection of science and practice. We bring over 15 years DUNS Number: 826391034 of experience to your research and development, along with accurate Small Business NAICS codes: documentation, rigorous quality control, and regulatory compliance. We work efficiently under tight project deadlines without compromising quality. 518210 541519 541611 541690 541712 541720 541990 611420 611430 We work with clients interested in ongoing communication and dialogue between disciplines and our experience comes from collaborating with many researchers over a wide range and complexity of studies in epidemiology and various medical and device specialties. We are committed to providing and maintaining the highest scientific rigor and ethical standards—while providing both timely and cost-effective services. Commitment to Excellence EmpiriStat Launches 2010 We at EmpiriStat are committed to building “We have the passion for Boot Camp Training Series long lasting collaborative relationships with making things happen with an Our 2010 Boot Camp Training Series was our clients. We believe that to forge these developed by professionals who have urgent patience, optimism, and effective relationships, we must remain hands on experience in all phases of clinical a tolerance for uncertainty. It is research. Training Series include true to our key values: responsibility, educational modules for Biostatistics, Data integrity, value, and commitment to not just the respect for our Management and Standards, excellence in every role and task we knowledge in the field that we Pharmacovigiliance and Safety Reporting, undertake. Clinical Monitoring and Data and Safety possess, but taking action and Monitoring Board Training. Each course is doing valuable work with that presented once per Quarter at specific Our underlying foundation at EmpiriStat is locations and is offered on-site or at a a belief that we can make a difference in knowledge.” central location designated by the client. the world and we will try to do that each Facility and meeting planning for a central and every day. We have the passion for ~ Dr. Nicole Close, President location may be arranged by an EmpiriStat Meeting Planner Manager on behalf of the making things happen, coupled with a genuine reserve of good will, from client. Please contact us to request our professionals who are excited to share and contribute their knowledge and Training Brochure. experience, but who are equally compelled to learn and to engage themselves in that process to continually improve corporately, professionally and personally. 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. 3. SELECTED CASE STUDIES Challenge: A pharmaceutical Services company was only months away We offer the following major clinical research collaboration and services: from filing their NDA with the FDA. They did not have an in- Biostatistics and Statistical Programming house Biostatistics/Statistical Data and Safety Monitoring Board Services Programming group for review Project Management and Auditing and writing of the ISS SAP and Statistical Software and Programming Validation to conduct the validation Clinical Data Management Assistance programming for their program. Site Selection and Qualification Solution: EmpiriStat Clinical Monitoring collaborated with the company Safety Monitoring and Reporting Services and provided all of the services Scientific Administrative Support required as the Sponsor’s in- house Biostatistics and Statistical Programming group Biostatistics and Statistical Programming to support both the ISS and the EmpiriStat provides a wide range of services throughout every project and NDA filing within a very clinical trial phase. Some services – such as statistical programming of table, condensed timeframe without listing, and figure shells – provide a cost savings to our collaborator if compromising quality. programmed and validated while the trial is Result: The company received ongoing (instead of during the database closure and the biostatistical guidance, analysis phase). The range of our assistance can be writing, review and statistical categorized loosely by project/trial phase validation programming from (Implementation, Ongoing, Database Closure and EmpiriStat to complete the filing Analysis Phase, Post Clinical Trial Phase, and within the existing company General) and range from hypothesis, objectives and endpoint planning, Protocol timelines. The company saved time and money by consulting and Statistical Analysis Plan writing/review, Sample size/power calculations, with EmpiriStat who provided Statistical programming specifications, to Interim data monitoring/analysis, flexible, time efficient and cost Database review and cleaning, and Primary statistical analysis and secondary effective services in an review of statistical analysis and interpretation. expedited manner set by the client’s needs. Data and Safety Monitoring Board Services Establishing, managing, and participating on a Data and Safety Monitoring Challenge: The client had Board (DSMB) is a serious process. EmpiriStat has the skills, knowledge, and contracted with EmpiriStat for experience to perform DSMB services professionally and effectively. As a part-time Senior Clinical and partner in the process, we assist the Sponsor in DSMB member identification Regulatory Affairs Management and selection, DSMB training, and our professional management and secure and expertise. The client was data analysis and delivery ensures leadership to assist with establishing the also in the process of contracting for a full service CRO objectives, responsibilities, and procedures through an official charter, to provide Data Management, expertise to establish procedures for the review of safety data and we are fully Clinical Monitoring, Safety qualified to act as the unblinded partner in performing the statistical analysis Reporting, Biostatistics, and and facilitation of the exchange of information between the DSMB members, Regulatory support for their chair, and Sponsor. multi-center clinical trial. However, the client was having contracting difficulties and the trial timelines were being Project Management and Auditing delayed. EmpiriStat has the experience and capability to succeed at collaborating and managing overall projects and clinical trials beyond Biostatistical services. Solution: EmpiriStat was Many clients find our management capabilities an invaluable aspect of our contracted by the client to larger collaboration. Our management services include project leadership and expand their current services to management of clinical trials, epidemiologic studies, health surveys, and 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. 4. provide a Bridge until the CRO surveillance studies; Auditing of vendor facilities and services for statistical could be selected and analysis, programming and Computer system 21 CFR Part 11 compliance contracted. In a condensed qualification and auditing. timeline of just 4 months, EmpiriStat created the deliverables and provided the on-site professionals to initiate Statistical Software and Programming Validation the clinical trial (including Validation is a critical element in clinical trials, and EmpiriStat provides valuable complete Case Report Forms, Manual of Procedures, a Safety insight for the entire validation process, including assistance with validation Reporting System, Study procedures and documentation of statistical software installation, operation Specific Procedures, and performance qualification, SAS® Macro and statistical programming Establishment and procedures validation, and independent review and assessment of corporate statistical for a Data and Safety Monitoring software validation procedures, processes and documentation. Board, all training modules, Clinical Monitoring Plan and 2 certified research coordinators Clinical Data Management Assistance and one professional Effective and well-executed data management is a vital part of any project or consultant). A clear transition clinical trial, and EmpiriStat’s guidance of clinical data plan was developed between management ensures the quality of your results. Such EmpiriStat’s Bridge of services services include design and review of case report forms, to the CRO. write and review Data Management Plans and edit Result: The client moved specifications, design data entry structures appropriate forward with the deliverables for clinical and laboratory data and provide edit specification programming and required to initiate the trial validation. New in 2010, EmpiriStat is showcasing their paper reduction data without further delay, had no collection technology “EmpiriSource.” cost or delay associated with a new group getting up to speed on the trial since EmpiriStat was Site Selection and Qualification currently providing management Selection, evaluation and qualification of clinical sites and investigators are guidance, and will save time and critical for the successful execution and completion of clinical trials within money when the CRO is hired budget and timelines. The site selection process and the relationship of the since all primary deliverables sponsor-site-investigator are key areas of opportunity in accelerating the drug have been created for the study. development process while generating high quality data. Site selection is a key conscious decision that needs to be made by the Sponsor in which both obvious Challenge: A European device and underlying challenges are addressed and the opportunities for improving company was preparing for filing efficiency are made. Considerations we take into account are the potential of with the US FDA with a device patient recruitment and retention; the growing scarcity of experienced already approved in Europe. investigators who bring relevant experience to your trial, quicker start-up They had consulted with an processes, the increased competition among Sponsors for sites, patients and academic Biostatistician in the experienced investigators, increased globalization of trials and key players, and US, but were unsure of the FDA and international regulations. EmpiriStat assists the Sponsor in creating analyses and recommendations the process, taking an in-depth look at specific steps and/or a critical analysis of that the Biostatistician had existing practices, challenges and provides an opportunity to formulate a more made and was looking for an independent opinion. solid partnership between Sponsors, sites and investigators. Solution: EmpiriStat was Clinical Monitoring Services consulted to review the Frontline attention to detail and quality comes from well-developed clinical statistical analyses and monitoring plans and their appropriate execution. EmpiriStat embraces the recommendations and to provide philosophy that the biostatistician and data manager works with the clinical their own assessment prior to the company filing. EmpiriStat monitor in those plans in order to provide insight into key variables and issues statisticians (PhD Biostatistician of data collection and recording that may have an impact on the final analyses. with US Regulatory experience Early identification prevents issues later and saves staff time and costs. We and an EmpiriStat UK Statistical assist our collaborators with expertise in quality assurance of study operations, 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. 5. Consultants versed in EMEA written and implementation of clinical monitoring plans, on-site data audits and guidances) reviewed the monitoring reports, and protocol compliance and regulatory compliance information and provided a review. detailed Statistical Risk Analysis of the filing. Safety Monitoring and Reporting Services Result: The device company EmpiriStat offers a comprehensive plan to help you manage your pre- and post- was provided with a detailed marketed product safety program. This management and services may include Statistical Risk Analysis summary and an independent SAE/AE Handling, Adverse event (AE) and serious adverse event (SAE) data assessment. The company entry and logging, examining current treatment utilization patterns, AE and SAE made modifications to their filing evaluations, SAE narrative writing, literature reviews and summaries, based upon EmpiriStat’s Regulatory Reporting, Generation of MedWatch 3500A/CIOMS forms, recommendations and preparation of periodic safety update reports (PSURs) and periodic adverse successfully filed with the US drug experience reports (PADERs), and prompt notification of potential FDA. expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports. We follow the FDA's Good Pharmacovigiliance Practices and EMEA's European Directive 2001/20/EC guidelines and focus our work-products on the end-user perspective. Industries We Serve Government For those studies that require use of an Independent Safety Monitor, our Biotech EmpiriStat Consultants stand ready to perform those functions as well, safely Pharmaceuticals partitioned and fire-walled from our Safety Department and project staff. Neutraceuticals Academic Vaccines 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 For personalized attention mind, EmpiriStat recognizes these challenges and provides the following contact us at: services to support your team: Administrative management of Data and Safety Monitoring Boards, Prepare and distribute paper and electronic documents, EmpiriStat, Inc. Arrange and provide on-site management of local or international conferences 13694 Sam Hill Drive and Investigator kick-off and training sessions, Schedule conference calls and Mount Airy, MD 21771 meetings and taking minutes at scientific meetings and during conference calls. Tel: 866.935.STAT Fax: 866-.276.STAT Email: info@empiriStat.com Biostatistical Synergy derived from the Greek synergos, συνεργός meaning working together 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 www.empiristat.com 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 of every project. Whether you need full scope global services or only one particular service offering like statistical analysis and programming. 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