2011 empiristat corporate capabilities

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

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REACH CLOSER to the Truth

EmpiriStat, Inc. 2011 Corporate Capabilities Summary

BIOSTATISTICAL SYNERGY


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Corporate Capabilities

Summary REACH CLOSER to the Truth

Quick Facts Woman-Owned Small

Business

Federalwide Assurance (FWA) A00015488

CAGE Code: 53F97

DUNS Number: 826391034

Small Business NAICS codes:

518210 541519 541611 541690 541712 541720 541990 611420 611430

EmpiriStat, Inc. Professional Development and Training

Education and training is the cornerstone of EmpiriStat. Without the tools for continuous improvement professionally and personally, we believe we lose the insight, knowledge, and passion to further ourselves, our career, and our business. Training is the process of developing specific skills to perform a certain job or task more efficiently, and education is noted to be the overall development of the human mind. EmpiriStat offers a wide range of specific training sessions, such as Good Clinical Practice (GCP) training, Site Management Training, or Data and Safety Monitoring Board (DSMB) Training. We also offer a wide variety of Professional Development courses, such as Educational Modules in Biostatistics for Non-Statisticians, Epidemiology, Data Management, and Pharmacovigilance. Please contact us to request a Professional Development and Training Brochure.

About EmpiriStat, Inc. EmpiriStat was founded with a unique goal: to discover the truth as far as 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, present and future. Applying rigorous methodologies and experience at every point along this timeline results in outcomes that are as close to the truth as possible. Our work lies at the intersection of science and practice. We bring in depth experience to your research and development, along with accurate documentation, rigorous quality control, and regulatory compliance. We work efficiently under tight project deadlines without compromising quality. 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 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 role and task we undertake. Our underlying foundation at EmpiriStat is a belief that we can make a difference in the world and we will try to do that each and every day. We have the passion for making things happen, coupled with a genuine reserve of good will, from professionals who are excited to share and contribute their knowledge and experience, but who are equally compelled to learn and to engage themselves in that process to continually improve corporately, professionally and personally.

“We have the passion for making things happen with an urgent patience, optimism, and a tolerance for uncertainty. It is

not just the respect for our knowledge in the field that we possess, but taking action and doing valuable work with that

knowledge.”

~ Dr. Nicole Close, President


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SELECTED CASE STUDIES

Challenge: A pharmaceutical company was only months away from filing their NDA 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 the validation programming for their program.

Statistical Analysis: 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 the Biostatistical guidance, writing, review 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 the client to expand their current services to provide a Bridge until the CRO could be selected and contracted. In a condensed

Services We offer the following major clinical research collaboration and services:

Biostatistics Statistical Programming Data and Safety Monitoring Board Services Project Management Statistical Software and Programming Validation Clinical Data Management Clinical Site Management Clinical Monitoring Services Safety Monitoring and Reporting Services Regulatory Support Services Scientific Administrative Support Biostatistical Synergy

Biostatistics and Statistical Programming EmpiriStat provides a wide range of services throughout every project and clinical trial phase. Some services – such as statistical programming of tables, listings, and figure shells – provide cost and time savings to our collaborator if programmed and validated while the trial is ongoing (instead of during the database closure and analysis phase). The range of our assistance can be categorized loosely by project/trial phase (Implementation, Ongoing, Database Closure, Analysis, Post Clinical Trial, and General) and range from hypothesis, objectives and endpoint planning, Protocol and Statistical Analysis Plan writing/review, Sample size/power calculations, Statistical programming specifications, to Interim data monitoring/analysis, Database review and cleaning, and Primary statistical analysis and secondary review of statistical analysis and interpretation. Data and Safety Monitoring Board Services Establishing, managing, and participating on a Data and Safety Monitoring Board (DSMB) is a serious process. EmpiriStat has the skills, knowledge, and experience to perform DSMB services professionally and effectively. As a partner in the process, we assist the Sponsor in DSMB member identification and selection, DSMB training, and full administrative support services. Our professional management and secure data analysis and delivery ensures leadership to assist with establishing the objectives, responsibilities, and procedures through an official charter. We also have the expertise to establish procedures for the review of safety data, and we are fully qualified to act as the unblinded partner in performing the statistical analysis and facilitation of the exchange of information between the DSMB members, DSMB Chair, and Sponsor.


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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, Establishment and 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. It 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 US FDA with a device already approved in Europe. They had consulted with an academic Biostatistician in the US, but were unsure of the analyses and recommendations that the Biostatistician had made and was looking for an independent senior statistical opinion.

Solution: EmpiriStat was consulted to review the statistical analyses and recommendations and to provide their own assessment prior to the company filing. EmpiriStat statisticians (PhD Biostatistician with US Regulatory experience and an EmpiriStat UK Statistical Consultants versed in EMEA guidances) reviewed the information and provided a

Project Management EmpiriStat has the experience and capability to succeed at collaborating and managing overall projects and clinical trials beyond statistical services. We have the ability to provide critical leadership across the entire project team, and we work with the sponsor to complete deliverables and strive to meet project timelines and budget specifications. Our Project Management support will guide your study with seamless communication that will define and complete your project on time, and on budget. Some of our PM services can include “hands-‐on” oversight from concept to completion, coordination and review of project deliverables such as Protocols, CRFs, and other clinical study tools, and study budget forecasting and contract negotiation. We also develop Risk Analysis Plans, Outsourcing Plans, and Contingency Plans to reach your project milestones.

Statistical Software and Programming Validation Validation is a critical element in clinical trials, and EmpiriStat provides valuable insight for the entire validation process, including assistance with validation procedures and documentation of statistical software installation, operation and performance qualification, SAS® Macro and statistical programming validation, and independent review and assessment of corporate statistical software validation procedures, processes and documentation.

Clinical Data Management Effective and well-‐executed data management is a vital part of any project or

clinical trial, and EmpiriStat’s Data Management services 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, Data Management Plans, and the development of edit specifications. We also have the ability to develop and

implement a clinical database to collect and store study data, and perform medical coding using MedDRA and WHO Drug dictionaries. EmpiriStat is proud to be capable of supporting studies that are paper-‐based, electronic, or a hybrid of both.

Clinical Site Management Selection, evaluation and qualification of clinical sites and investigators are critical for the successful execution and completion of clinical trials. The site selection process and the relationship of the sponsor-‐site-‐investigator are key areas of opportunity in accelerating the drug and device development process while generating high quality data. Site selection is a crucial decision that needs to be made by the Sponsor in which both obvious and underlying challenges are addressed and efficiencies are made. Considerations we take into account are the potential of patient recruitment and retention; the experience of the site Principal Investigator, quicker start-‐up processes, the increased competition among Sponsors for sites, patients, increased globalization of trials and key players, and FDA and international regulations. EmpiriStat assists the Sponsor in creating site selection and management processes by taking an in-‐depth look at specific steps and/or a critical analysis of existing practices, challenges and provide an opportunity to formulate a


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detailed Statistical Risk Analysis of 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 upon EmpiriStat’s recommendations and successfully filed with the US FDA.

Therapeutic Experience

• Infectious Diseases • Vaccines • Traumatic Brain Injury • Transplants and Immunology • Anti-Infectives • Reproductive Health • Medical Devices • Dermatology • Blood Products • Wound Care • Oncology • Diabetes • Cardiovascular Disease

Global Depth and Diversity

• Government

• Non Profit Organizations

• Private Industry

• Academic

• Private Practices

“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

more solid partnership between Sponsors, sites and investigators. Our team has successfully implemented clinical trial sites, and we have proven processes for starting new sites that remain lasting ones through in-‐depth training, education and continual mentoring.

Clinical Monitoring Services Frontline attention to detail and quality comes from well-‐developed clinical monitoring plans and their appropriate execution. EmpiriStat embraces the philosophy that the biostatistician and data manager works with the clinical 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 assist our collaborators with expertise in quality assurance of study operations, writing and implementing clinical monitoring plans, monitoring reports, as well as protocol and regulatory compliance review.

It’s our standard to have a very short turnaround time for issuing our reports. Something we take great pride in and have been commended on by many of our clients.

Safety Monitoring and Reporting Services EmpiriStat offers a comprehensive plan to help you manage your pre-‐ and post-‐marketed product safety program. This management and services may include Serious Adverse Event (SAE) and Adverse Event (AE) reporting, SAE and 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 update reports (PSURs) and periodic adverse drug experience reports (PADERs. 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.

For those studies that require use of an Independent Safety Monitor, our EmpiriStat Consultants stand ready to perform those functions as well, safely partitioned and fire-‐walled from our Safety Department and project staff.

Regulatory Support Services EmpiriStat offers tailor made regulatory services to assists Sponsors and Investigators with the administrative activities involved in meeting the regulatory requirements for research involving human subjects. We can assure that study projects and protocols comply with federal, state, and institutional requirements governing the conduct and implementation of each trial, and can serve as a liaison between the FDA, the IRB, Investigators, and Research Staff. Additionally, we can offer consultation and guidance regarding the application to the FDA regarding your product or device, support for FDA and IRB submissions, assistance with registering trials on ClinicalTrials.gov, assistance with Pre-‐IND meetings, Type B Meetings and other regulated meeting requests, and guidance for FDA audits.


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For personalized attention contact us at:

EmpiriStat, Inc.

13694 Sam Hill Drive Mount Airy, MD 21771

Tel: 866.935.STAT Fax: 866-.276.STAT

Email: [email protected]

www.empiristat.com

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, and coordination of Investigator kick-‐off meetings. Also provided are the coordination and scheduling of science team meetings, and taking minutes during these group collaborations.

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 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, 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


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2011 empiristat corporate capabilities

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