Nicole C. Close, PhD
President and Principal Biostatistician
Qualities: As founder, president, and principal biostatistician at EmpiriStat, Nicole is the driving force behind the company's success. With an eternally optimistic outlook, a passion for hard work and detail, and a unique creativity and humor, Nicole inspires her team and clients alike to surpass expectations. She values a good work/life balance and encourages the same in her team—she is an avid International trainer in clinical trials, enjoys her advanced scuba certification, loves learning about new cultures and food while traveling, and doesn't miss a game for her beloved Pittsburgh Steelers.
Role: Nicole serves as the senior biostatistician to EmpiriStat statisticians and statistical programmers. She provides guidance for regulatory submissions work, leadership for clinical development projects, and is directly responsible for the statistical integrity, adequacy, and accuracy of the clinical studies developed and produced by her colleagues.
Background:
- Trained in Epidemiology and Biostatistics (Juniata College, Case Western Reserve University and The George Washington University)
- More than 16 years of professional experience conducting and managing clinical trials and epidemiological research—including the management of coordinating centers and large-scale, multi-site data collection and statistical analysis activities
- Board Member, Committee Chair, and workshop faculty member for a variety of professional organizations including the American Statistical Association (ASA), The Society for Clinical Trials (SCT), and the International Society for Clinical Biostatistics (ISCB). She is a peer reviewer for several organizations including the Congressionally Directed Medical Research Program (CDMRP), the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA), as well as training members and serving on various Data and Safety Monitoring Boards
- Founded EmpiriStat in 2008
Devin J. Hunt
Manager, Statistical Programming and Clinical Data Management
Qualities: Devin embodies the rare combination of out-of-the-box thinking with extraordinary left-brained organization. He has an unparalleled ability to structure data in a way that is crystal-clear yet also illuminates deeper, more meaningful information. Beginning his career as a Data Manager and Database Programmer and transitioning to Statistical Programming, Devin offers a unique and complete perspective of the data collection and analysis process. His attention to detail ensures that potential problems are addressed prior to them becoming issues.
Mimicking his busy work life, Devin remains active in his free time. He is often found reading tech blogs, studying his textbooks, learning new computer languages, playing video games, taking photos, and participating in extreme sports like skydiving, paintball, flying trapeze, and high-ropes courses.
Role: As Manager of Statistical Programming and Clinical Data Management, Devin provides SAS programming and Data Management support for clinical trial data and provides technical knowledge for clinical trial design and implementation. He is responsible for the development and review of databases for various projects, and confirms that the trial accurately collects the data needed to address the research questions. He is also responsible for the overall management of other statistical programmers, data management personnel and activities, and the function of the team as a whole.
Background:
- Trained at Juniata College for a B.S. degree and currently completing a M.S. degree at The George Washington University
- SAS Certified Base Programmer for SAS 9 with a wide range of experience in Pre-clinical to Phase III clinical trials
- Experienced in providing complete Data Management services consistent with current Good Clinical Data Management Practices
- Expertise with Clinical Data Interchange Standards Consortium (CDISC) modules which are currently being implemented within the pharmaceutical and biotech industries
- Current member of the Society of Clinical Trials, Society for Clinical Data Management, and serves on the education committee for the Society of Clinical Trials
Fawna L. Start, CCRC, BS
Manager, Site Management and Clinical Monitoring
Qualities: Fawna's education and 15 years of experience in clinical coordination, monitoring, project management, regulatory affairs, and auditing, phase II – IV clinical trials in multiple therapeutic areas for both FDA and non FDA regulated trials makes her an invaluable member of the team. As a military spouse and mother of three she knows all about juggling personal and professional life, AND who says you can't have both! She enjoys hunting, camping and loves to just take a stroll on her Harley. She always strives for perfection and would never ask anyone to do anything that she would not do herself. She is committed to the team approach and her strong work ethic shines through in all she does. Her informative style of communication, leadership skills and strong work ethic, as well as her dedication to quality is apparent in everything she does.
Role: As the Manager of EmpiriStat's Site Management services, Fawna will ensure site staff has all the tools necessary to complete one or more trials from start-up to close-out including coordinator training, administration, IRB requirements and submissions, documentation, as well as continued support through the duration of the trial. Fawna builds and manages relationships with the team to ensure all sponsor requirements are met. As a clinical research professional Fawna has in-depth knowledge of regulatory and site requirements.
As the Manager of EmpiriStat's Clinical Monitoring services, Fawna has structured her monitors as part of the research team, not there to find fault but to assist sites and sponsors to have the highest quality documentation and data possible. With a keen eye and attention to detail along with her ability to motivate others, Fawna's expertise in clinical monitoring will ensure integrity of data.
Background:
- Over 15 years of Clinical Research Experience and Certified Clinical Research Coordinator
- Bachelors of Science in Exercise Physiology
- While the regional coordinator for not for profit organization, provided services to the Walter Reed Army Medical Center IRB
- As Research Coordinator, recognized repeatedly by Sponsors as the top clinical trial enroller in the country and worldwide
- Served as the Director of Regulatory for a Site Management Organization (SMO) ensuring all regulatory requirements were met throughout all sites and all trials across the country
- Experienced in Auditing / monitoring and quality assurance for multiple trials and therapeutic areas
Caylee A. Ortega
Director of Business Development and Senior Contract Administrator
Qualities: Caylee is a true patriot who served in the U.S. Army. With her military background, Caylee is an energetic motivator and cheerleader for EmpiriStat, with passion and ethical integrity that inspires the whole team. Her attention to detail is perfectly balanced by her sense of humor.
Role: As Director of Business Development, Caylee leads and develops the company’s business development activities. She builds and manages client/market relationships with potential new clients and agencies to facilitate new client business growth. She also develops strategies, business plans and captures activities for future work consistent with overall company strategy.
As Contract Administrator, Caylee manages contract documents and all associated files. As a Defense Acquisition Professional, she possesses an in-depth understanding of federal contracting and acquisition. She assists with contract development, administration, tracking, and analysis—as well as communicates supplier performance and contract compliance. She reviews all contract modifications, extensions and contract closeout documents.
Background:
- U.S. Army Veteran
- Defense Acquisition Certified Program Manager with over 23 years experience in Department of Defense Activities including Business Development, Strategic Planning, Government Contracting, Defense Acquisition, and Program Management
- Managed the Business Operations of a multimillion dollar Medical Research Information Systems Program (MeRITS)
- Served as Program Manager of a Clinical Research Organization providing bench-to-bedside services to the Department of Defense for the Walter Reed Army Institute of Research (WRAIR), the WRAIR Clinical Trials Center, and the WRAIR Pilot Bioproduction Facility, managing over 200 employees
Laura A. Melia, P.A.
Corporate Counsel
Qualities: Corporate Counsel, Laura Melia brings a wealth of professional and personal qualities to the EmpiriStat team. After graduating from Loyola College in Baltimore, Maryland, Laura received her law degree from the University of Baltimore School of Law in 1992. She is a Member the Professional Advisory Council of the Community Foundation of Frederick County and is a former Board member and general counsel to Habitat for Humanity of Frederick County.
Laura effectively balances the requirements of her profession with the needs of her beloved family and the needs of her community. When not attending to the needs of her husband, two kids, and two dogs, Laura enjoys hiking, biking, skiing, and remaining active in her community. When asked what her “Calgon moment” might be, Laura smiles and pictures herself on a deserted beach somewhere in the Caribbean, icy cold Margarita in hand, and a masseur named Sven massaging her feet.
Role: As Corporate Counsel for EmpiriStat, Inc., Laura negotiates the legal needs of the company, addressing documents such as confidentiality disclosure agreements, non-disclosure agreements, partnering agreements, contracts and more. She ensures that employer discrimination laws are complied with and fair labor rules are obeyed, all with her glowing smile. More importantly, Laura implements the high caliber of responsibility and ethics of EmpiriStat in every document exercised for the company.
Background:
- 18 years as an attorney with an emphasis on business law, estate planning and real estate transactions
- Expert negotiator with a track record of successful settlements and contract negotiations
- Respected contributor on a wide variety of legal issues to multiple professional and charitable organizations
- Superior research and legal brief writing skills, with undergraduate degree in writing
- Hard-working, diligent professional willing to learn new skills and go the extra mile to make a positive contribution
- Member of Maryland State Bar Association (Real Estate and Business Sections) and Frederick County Bar Association