FDA Representation for pharmaceutical, biotechnology, and medical device companies
Senior Management
President
Executive Vice President, Chief Scientific Officer
Vice President, Clinical Operations
Senior Director, Clinical Operations
Senior Director, Strategic Development
Director, Statistical Programming
Associate Director, Biostatistics
Director of Finance
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.
Vice President, Clinical Operations
Michelle Currie is Vice President of Clinical Operations at Veristat, Inc. After holding positions of increasing responsibility in the contract research organization and biotech settings, Ms. Currie joined the company as Director of Medical Writing Services in 2000. Over the subsequent years, Ms. Currie’s role within the company has expanded as the business has grown. While at Veristat, she has participated in several successful NDA/BLA filings, developed key company functions and policies, and contributed toward the expansion of Veristat’s client base. As the head of Clinical Operations, Ms. Currie is responsible for cross-functional project planning, budget development and oversight, resource management within and across projects, staff mentoring, vendor management, and project operational support. Working with Business Development and Clinical Operations personnel, she works to build and maintain strong, effective relationships with clients, vendors, and other clinical research partners. Prior to joining Veristat, Ms. Currie served as Manager of Medical Writing at Idenix Pharmaceuticals, Inc. (formerly Novirio Pharmaceuticals, Inc.). At Idenix, she started the medical writing function, including development of standard procedures and templates for clinical study documents, and prepared and assisted with the filing of pre-INDs and INDs for antiviral agents. Ms. Currie began her career in the pharmaceutical industry in 1992 at PAREXEL International Corporation. At PAREXEL, she held positions of increasing responsibility in the Medical Writing Services group. Ms. Currie assisted with the writing, review, and compilation of two successful NDAs. Additionally, she prepared numerous clinical documents in a variety of indications, primarily focusing on the human immunodeficiency virus (HIV). Prior to joining the industry, Ms. Currie worked in human services. Ms. Currie holds a BA in Psychology from William Smith College.
Senior Director, Clinical Operations
Kathy Sachse is the Senior Director of Clinical Operations at Veristat Inc., and manages all aspects of clinical operations including oversight of Clinical Operations personnel (Clinical Monitoring, Clinical Project Management, Data Management, Database Development, Safety Services and Program Operations), on behalf of clients through management of internal and vendor personnel. Ms. Sachse oversees fiscal management of contracted project work, the development and maintenance of timelines, and allocation of resources for such work. She is responsible for resource allocation planning, maintenance of optimal department processes, and the development and implementation of strategies to increase project productivity and quality, while decreasing cycle times and costs. Ms. Sachse has over 25 years of experience in clinical research with extensive experience in the management of Phase 1-3 trials utilizing electronic data capture. She has a broad scope of experience in various therapeutic areas including executing trials involving HIV/AIDs, Anti-Infectives, Vaccines, Renal, Cardiovascular, and Neurological disease, including Device experience. Prior to joining Veristat in 2005, Ms. Sachse held the position of Data Project Manager within the Cardiovascular Division at Boston Scientific, Inc., with responsibility for oversight of clinical data management functions and EDC vendor management. Previously, she served as Manager, Clinical Data Analysts in charge of safety data review and coding at MTRA, Inc. and AAI Pharma Inc., Senior Clinical Data Manager at PAREXEL International Corporation, and as Project Coordinator at the Cancer Control Research Unit and the Perinatal Epidemiology Research Unit at the Yale University School of Public Health. Ms. Sachse holds an M.S. in Counseling and Guidance from Indiana University and a Sixth Year Certificate in School Psychology from Southern Connecticut State University.
Senior Director of Strategic Development
Cindy Henderson is the Senior Director of Strategic Development at Veristat, Inc., and is primarily responsible for all business developmentt and information technology services. Her responsibilities include oversight of the IT and Business Development personnel, resource allocation, creation and maintenance of departmental Standard Operating Procedures, support for business 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. 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, 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 26 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.
Associate Director, Biostatistics
Chris Schoonmaker is the Associate Director of Biostatistics at Veristat, Inc. Mr. Schoonmaker is primarily responsible for coordinating the activities of the Biostatistics department. In addition to Mr. Schoonmaker’s senior management responsibilities, he is the lead statistician on several ongoing clinical trials (specializing in oncology and vaccines), serves as an active member on Data Safety Monitoring Boards (DSMBs), and provides statistical consultation on a range of topics and indications. He has more than ten years of statistical evaluation experience in the health care industry. Prior to joining the pharmaceutical industry, Mr. Schoonmaker was a data analyst for an evaluation firm analyzing data related to adolescent health, early childhood development, and AIDS treatment adherence. While at Boston University, Mr. Schoonmaker provided data management and statistical support at the Framingham Heart Study and taught an introductory SAS/statistical computing class. He has provided statistical consultation for a variety of medical and health care studies related to cardiovascular disease, adolescent nutrition, and infant mortality among others, and has extensive experience in data management and advanced statistical analyses. Mr. Schoonmaker received his Master’s of Public Health in Epidemiology and Biostatics from Boston University and thereafter received PhD level training in Biostatistics.
Director of Finance
Doug Beckerman is the Director of Finance at Veristat, Inc. and is primarily responsible for the business and financial strategy of the company through planning, monitoring, and managing the financial operations. Mr. Beckerman has a varied background in both the software and biopharma service industries including financial applications and analysis, business and resource forecasting, client and corporate contracting, strategic alliances, and corporate planning. Most recently, Mr. Beckerman was the Group Leader of Finance, Legal and Human Resources for BBK Worldwide, a leading global clinical trial patient recruitment-marketing consultancy. At BBK, Mr. Beckerman was instrumental in the establishment of the company’s international subsidiaries, providing the financial support for a spin-off of the company’s technology offering into a separate company and enhancing the client contracting process. Prior to BBK, he was the Director of Finance and Administration at Auspice Corporation, a start-up operations automation software provider. At Auspice, Mr. Beckerman built the financial and human resource infrastructure from the ground up and provided financial support for successful rounds of angel financing. Before Auspice, he was the Controller at Tasking Inc., a leading embedded software developer, where he drove the acquisition efforts of the company by analyzing and integrating an acquired company from the financial and human resource perspectives. Previous experiences included varied Analyst roles at Easel Corporation and Computervision Corporation, leading client server and CAD/CAM software providers, focusing on global financial and business planning and analysis. Mr. Beckerman holds an MBA from the Thunderbird School of Global Management and a BA degree in Economics from St. Lawrence University. Mr. Beckerman is an active member of the Institute of Management Accountants and a Massachusetts Notary.