FDA Representation for pharmaceutical, biotechnology, and medical device companies
Senior Management
President
Executive Vice President, Chief Scientific Officer
Senior Director, Strategic Development
Director, Human Resources and Office Management
Director, Statistical Programming
Director, Biostatistics
Director, Data Management
President
John Balser, PhD, co-founder and President of Veristat, Inc., has developed the company to its current size of over 90 professionals in the areas of clinical monitoring, data management, biostatistics and programming, medical writing, and project management. A strong core group of senior management representatives implement process efficiencies and service improvements. In addition to providing global direction for the company, Dr. Balser is actively involved with clinical projects in his role as one of Veristat's principal statistical consultants. In this role, he assists clients with clinical study design and program development based on his many years of experience in the statistical aspects of clinical research. He is often called upon to assist clients on a variety of statistical issues at meetings with regulatory agencies. Prior to founding Veristat in 1994, Dr. Balser served as Vice President, Biostatistics, and Data Management at Medical & Technical Research Associates, Inc. He has held positions of increasing responsibility in the biostatistics departments at various pharmaceutical companies including E.R. Squibb, Biogen, and Miles. Dr. Balser received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 25 years.
Executive Vice President, Chief Scientific Officer
Barbara Balser, co-founder, Senior Vice President and Chief Scientific Officer of Veristat, Inc., is primarily responsible for strategic planning and consulting, data quality, medical oversight, and production of regulatory submission documents. Dr. Balser has more than 25 years of clinical research experience that encompasses both the pharmaceutical and contract research organization industries. Her experience includes Phase I to IV trials across multiple therapeutic areas with a specific focus in oncology and anti-infectives. Dr. Balser has participated in the writing, oversight, and submission of multiple marketing applications to US, Canadian, and European Union regulatory authorities. Prior to co-founding Veristat, Dr. Balser served as Associate Director of Clinical Research at Medical & Technical Research Associates, Inc. where she was responsible for strategic planning, design, and management of clinical development programs in Phases I through IV; preparation and submission of regulatory applications; and scientific communications. Dr. Balser began her career in the pharmaceutical industry at Miles, Inc. (currently Bayer Corporation). In her capacity as Assistant Director of Clinical Research at Miles, Dr. Balser assisted with strategic planning for the clinical development of anti-infective compounds from Phases II to IV and with the planning, writing, and compilation of two successful NDAs for anti-infective products. Prior to joining the clinical industry, Dr. Balser practiced veterinary medicine at a private veterinary hospital. Dr. Balser holds a BS in Chemical Engineering from the University of Pennsylvania, School of Engineering and Applied Science, and a VMD from the University of Pennsylvania, School of Veterinary Medicine.
Senior Director of Strategic Development
Cindy Henderson is the Senior Director of Strategic Development at Veristat, Inc., and is responsible for all project management, business development, information technology and finance activities. Her responsibilities include oversight of those department personnel, resource allocation, creation and maintenance of departmental Standard Operating Procedures, support for department development activities, and representation of the corporation at client meetings and audits. As Senior Director of Strategic Development, Ms. Henderson ensures that Veristat is a technology leader by implementing and validating the appropriate technologies according to 21 CFR Part 11 requirements. In addition, Ms. Henderson works closely with other members of senior management in making strategic plans and decisions. Ms. Henderson has over 20 years of experience in various contract research organizations. Prior to joining Veristat in 2007, she served as Senior Manager of Training, Innovations and Processes at Averion International Corp., leading various initiatives to create and improve standard operating procedures and implement new technologies for data management as well as the overall corporation. Ms Henderson has a wide variety of experience from PAREXEL International Corporation, from serving as the Lead Clinical Data Manager on several international trials, to Manager of the Quality Process and Training department and Associate Director of Data Management. Additionally she served as the Project Manager for a large proprietary software development, validation, and implementation effort ensuring completion according to both the user requirements and 21 CFR Part 11 and within established timelines and budgets. Ms. Henderson is a member of the Drug Information Association (DIA).
Director, Human Resources and Office Management
Kathi Ritter is the Director of Human Resources and Office Management at Veristat, Inc. Ms. Ritter is responsible for the oversight of the Human Resource Department, including planning, directing and carrying out policies relating to all phases of personnel activity. Ms. Ritter oversees the recruitment, interviewing and selection of employees to fill vacant positions and plans and conducts new employee orientation. Ms. Ritter is also responsible for the selection of company benefits and maintenance of all personnel and facility records. Ms. Ritter is responsible for the supervision of administrative staff, negotiating facility and company contracts and oversees the maintenance of the facility. In addition, Ms. Ritter participates in strategic planning with other members of Senior Management. Before joining Veristat in 2003, Ms. Ritter worked in the legal and teaching fields. Ms. Ritter holds a BA from Merrimack College.
Director, Statistical Programming
Jeanne Corriveau is the Director of Statistical Programming at Veristat, Inc. and is primarily responsible for the statistical SAS programming aspects of clinical trial projects through management of internal staff. Her responsibilities include resource allocation, maintenance of department processes and procedures, assistance with the development of business proposals, and participation in client meetings and audits. Ms. Corriveau is also responsible for coordination of large CDISC projects, overseeing SDTM migration/QC and ADaM development/QC for ISS/ISE electronic submissions. Ms. Corriveau has over 28 years of clinical research experience with all phases of clinical trials in a variety of therapeutic areas. Prior to joining Veristat in 2007, she was Associate Director of the Waltham Biostatistics & Programming department at PAREXEL International, LLC. Ms. Corriveau holds a B.A. in Sociology from the University of Massachusetts with a concentration in research and analysis.
Director, Biostatistics
Amanda Truesdale is the Director of Biostatistics at Veristat Inc. Ms. Truesdale is responsible for overseeing the statistical aspects of projects and project teams. Ms. Truesdale is also responsible for resource allocation, maintenance of department processes and procedures, assistance with the development of business proposals, participation in client meetings and audits, and training staff members. Ms. Truesdale is actively involved in numerous projects and attends meetings with scientific advisory groups and regulatory bodies to support the statistical aspects of regulatory submissions. She helps plan, coordinate, and provide statistical analyses, summaries, and reports of studies in the support of product development including IND/NDA and BLA submissions, and IDE and PMA submissions. Ms. Truesdale has experience in a variety of indications, with extensive experience in infectious disease. Her research interests include sample size re-estimation and methods for handling missing data. Before joining Veristat in 2007, Ms. Truesdale worked as a Biostatistician at Averion Inc.
Director, Data Management
Natasha Ostavnenko is the Director of Data Management at Veristat, Inc. Ms. Ostavnenko is primarily responsible for coordinating the activities of the Data Management department, including management of internal staff, resource allocation, maintenance of department processes and procedures, assistance with the development of business proposals and participation in client meetings and audits. In addition to Ms. Ostavnenko’s management responsibilities, she is the lead data manager on several ongoing clinical trials in therapeutic areas including oncology, GI disorders and immune system disorders. Ms. Ostavnenko has more than ten years of clinical research experience with all phases of clinical trials in a variety of therapeutic areas. Prior to joining Veristat in 2011, she held several managerial positions in the data management area at pharmaceutical companies including Idera Pharmaceuticals, Sirtris Pharmaceuticals and Altus Pharmaceutials. Ms Ostavnenko holds a Master of Science degree from the Ukrainian National Technical University in Kiev.