Leadership Team

Patrick Flanagan is Chief Executive Officer at Veristat, responsible for the company’s business management and financial performance. In collaboration with company leaders, Patrick is responsible for the development and implementation of Veristat’s organizational goals and business strategies.

Patrick has built a 23-year career leading commercial growth, international expansion and financial & operational improvement initiatives for leading companies in the consulting, healthcare, and software fields including A.T. Kearney, Baxter International, Allegiance Healthcare and Oracle. Prior to joining Veristat, Patrick served as Chief Operating Officer of Certara and the General Manager of Certara’s Pharsight Consulting Services Group, a Vector Capital portfolio company engaged in the business of providing consulting services and software to pharmaceutical and biotechnology companies.

Patrick holds a BS in Business from Penn State University and an MBA with a concentration in Finance and Marketing from the Kellogg Graduate School of Management at Northwestern University. Patrick is also an active father, skier, golfer, occasional marathon runner and aging tri-athlete.

John Balser, PhD, co-founder and President of Veristat, has developed the company as industry leaders in areas of clinical monitoring, data management, biostatistics and programming, medical writing, and project management. John 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, John 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.

John received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 25 years. John is an avid runner and has competed in the Boston Marathon.

Barbara Balser, VMD, co-founder, Executive Vice President and Chief Scientific Officer of Veristat, is primarily responsible for strategic planning and consulting, medical oversight, and production of regulatory submission documents. Barbara has more than 30 years of clinical research experience that encompasses both the pharmaceutical and contract research organization industries. Her experience includes oversight and production of Investigational New Drug (IND) applications, regulatory agency briefing documents, preparation for and representation at advisory panel meetings, and consultation across Phase 1 to 4 trials in multiple therapeutic areas with a specific focus in oncology and anti-infectives. Barbara has participated in the writing, oversight, and submission of multiple marketing applications to US, Canadian, Japanese, and European Union regulatory authorities. Prior to co-founding Veristat, Barbara 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; preparation and submission of regulatory applications; and scientific communications.

Barbara began her career in the pharmaceutical industry at Miles, Inc. (currently Bayer Corporation). In her capacity as Assistant Director of Clinical Research at Miles, Barbara assisted with strategic planning for the clinical development of anti-infective compounds from Phases 2 to 4 and with the planning, writing, and compilation of two successful NDAs for anti-infective products. Prior to joining the pharmaceutical and biotech industry, Barbara practiced veterinary medicine at a private veterinary hospital. Barbara 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. When Barbara isn’t busy traveling the world for our clients, she enjoys spending time on the beach with a good book.

As the Chief Financial Officer, Jason oversees all strategic and tactical matters as they relate to financial planning, budget management, and forecasting needs. Additionally, he drives the visibility of the financial data needed to inform and support the Company's operational and growth plans.

He joined Veristat with over 15 years of financial experience in the CRO industry. Before his current role, Jason served as VP of Finance at LabConnect and held several financial leadership roles at Covance, Inc. (a division of Labcorp) including Executive Director, Revenue & Project Analysis and Global Director, Financial Planning & Analysis.

Jason holds a BS in Business Management from North Carolina State University, an MA in Economics from Clemson University and an MS in Finance from Indiana University.

Cindy Henderson is the Executive Vice President, Strategic Development at Veristat overseeing the Proposals & Contracts  functions as well as building and managing partner relationships and collaborating with the executive team on corporate growth strategies. With over 20 years of experience, Cindy concentrates on providing innovative functional and operational support to Veristat’s diverse, sponsor-based clinical studies. Cindy’s key areas of operational expertise include the ability to lend deep insight into the sequence of events clinical studies take as they advance toward the goal of product regulatory submission, the ability to effectively manage and assess client needs, and the ability to strategically outline the required resources for clinical programs. Cindy is a primary contributor in all tactical strategic planning both within Veristat and within client projects.

Prior to joining Veristat in 2007, Cindy served as the Senior Manager of Training, Innovations and Processes at Averion International Corporation where she led various initiatives to create and improve standard operating procedures, while implementing new technologies for data management and was a member of the integration team for several key corporate acquisitions. While at PAREXEL International Corporation as the Associate Director of Data Management, Cindy managed several international clinical trials, developed SOPs and processes, provided training and participated in software development, validation, and implementation efforts.

Outside of Veristat Cindy is a Supervising Judge for the North American Flyball Association (www.flyball.org). She also competes in this fun and fast paced sport with her two border collies and miniature Australian shepherd as part of the Weston Whirlwinds Flyball Team (www.wwflyball.org).

Shaheen Limbada is the Executive Vice President of Global Clinical Operations at Veristat. In this role, Mr. Limbada oversees patient recruitment, site engagement, site monitoring, and site management teams. With over 20 years of experience running clinical trials, he excels in the areas of organizational development and execution, patient recruitment and retention, clinical study conduct and governance, and drug safety monitoring.

He joined Veristat through the recent acquisition of Topstone Research, a Canadian-based CRO that he co-founded and held the position of Managing Director. Prior to Topstone, he worked in clinical operations, project management and leadership roles at various clinical research organizations (CROs) and pharmaceutical firms including Leo Pharma, Cetero Research and AstraZeneca.

Mr. Limbada graduated from the University of Toronto and quickly began his career in clinical trials with AstraZeneca Canada Inc. on.

As Executive Vice President of Operations, Alecia provides strategic leadership for the Biometrics, Medical Writing, Regulatory Affairs, and Information Technology teams at Veristat.   With more than 25 years of clinical research experience and demonstrated success in developing and growing global teams, she will ensure the delivery of operational consistency and excellence to our clients who are preparing, conducting, analyzing, reporting and submitting clinical trial data to the regulatory agencies.   

Alecia has a broad background in executive and operational leadership from study start-up through submission activities at various global CROs including Chiltern, Charles River Labs, and IQVIA.  Throughout her career, she has supported global clinical trials across the following therapeutic areas:  Infectious Disease, Oncology, Respiratory, Vaccines, Endocrinology, and Cardiovascular Disease.  

She earned her Bachelor of Science in Biology from the University of North Carolina at Wilmington.

Lindsey Lukis is the Executive Vice President of Talent and Culture at Veristat, responsible for the people related programs and initiatives that allow Veristat to achieve its strategic growth plans.  Lindsey leads the Talent and Culture team to attract, develop, and retain Veristat’s human capital; she is also responsible for the Company’s short and long term people strategies, talent development, and fostering a culture of engagement, agility, and partnership. 

Lindsey joined Veristat in 2015 with prior experience in the retail, financial services, and energy industries, having worked for companies such as Bose Corporation and The Hanover Insurance Group.  She brings more than 15 years of progressive experience in the field of human resources with a particular focus/expertise in talent acquisition and management.  Lindsey holds a B.S. from James Madison University, focused in Organizational Communication Studies and Training and Development.  Outside of work Lindsey enjoys a full home life with her young family, practicing yoga, running and perhaps her most important role - hockey mom.

Mark Ammann is the Senior Vice President of Regulatory Affairs at Veristat. Prior to Veristat Mark was the owner and President of Catalyst Regulatory Services and established a successful Regulatory Affairs consulting practice at United BioSource Corporation where he served as Vice President of Regulatory Affairs and provided strategic regulatory consulting to a range of clients from start-up pharmaceutical companies to large multinational corporations. Prior to starting his consulting career, Mark held positions with increasing levels of responsibility within Regulatory Affairs for 18 years at three major pharmaceutical companies (Novartis, Pharmacia and Pfizer).

Mark is a recognized leader in the regulatory affairs community with an extensive knowledge of regulatory issues and the overall pharmaceutical development process. His excellent analytical, communication and negotiation skills have been used to effectively prepare and lead teams through many challenging health authority interactions.

Mark received his Doctor of Pharmacy degree from the University of Michigan.

Dr. Holinger is the Vice President of Regulatory Affairs at Veristat, a role in which she oversees the Regulatory consulting and operations team.  She works with sponsors to plan their programs and navigate the regulatory submission process throughout the entire drug development life-cycle.  

Mara earned her PhD in Molecular Microbiology from Tufts University School of Medicine and began her career as a lead scientist in anti-cancer research.  She provides pharmaceutical, biotech and medical device firms with strategic consulting to prepare their regulatory pathway; to design their clinical program and trials; to perform gap analysis for Chemistry, Manufacturing and Controls (CMC) and preclinical reporting and to write regulatory applications. Additionally, she is an expert in regulatory agency meeting preparation, moderation and logistical support, and serves as an Authorized Regulatory Representative and US Agent. Mara has written, reviewed or provided oversight for more than 20 Investigational New Drug Applications (INDs), multiple Orphan Drug Designation (ODD) applications, breakthrough designation applications, special protocol assessments, fast track applications and several New Drug Applications.

Rita recently joined Veristat through its acquisition of Certus PV.   In her new role at Veristat, she will lead and expand the pre-approval and post-marketing pharmacovigilance and safety surveillance team.  

Rita is a registered pharmacist with over 20 years of experience in global and Canadian pharmacovigilance. Her experience includes more than a decade of senior PV consultancy and ten years in increasingly senior PV roles within the pharmaceutical industry.

Before co-founding Certus PV Services, Rita spent five years in increasingly senior consultant roles at CanReg/OptumInsight. In her Senior Director PV role, Rita routinely provided expert pharmacovigilance guidance to pharmaceutical companies in Canada. She acted as the lead auditor in several audits and assisted companies in preparing for GVP inspections. Rita was also instrumental in setting up pharmacovigilance systems for Canadian companies. Rita’s previous work experience includes ten years at Novartis Consumer Health in Canada and Switzerland, including a global senior management role in aggregate reporting and case processing.

Rita is a recognized pharmacovigilance leader and educator, having presented at PV conferences/webinars organized by professional industry associations. She is a member of the Drug Information Association (DIA) and the Canadian Pharmacovigilance Network and has presented at several conferences/webinars organized by these professional associations.

Agnes recently joined Veristat through its acquisition of Certus PV.   In her new role at Veristat, she will lead and expand the pre-approval and post-marketing pharmacovigilance and safety surveillance team.  

Agnes has started her career in the pharmaceutical industry over 20 years ago.

She has 17 years of experience in global and Canadian pharmacovigilance within the pharmaceutical industry and senior PV consultancy roles. In addition to pharmacovigilance, Agnes's expertise includes medical information, regulatory affairs, and pharmaceutical sales.

Before co-founding Certus PV, Agnes was a Director, PV at OptumInsight. In this leadership function, she headed the PV & MI Department at one of Canada's ten most prominent pharmaceutical companies. She provided strategic PV & MI advice for over 15 other clients. Having led numerous PV audits of contractual partners and vendors on behalf of Marketing Authorisation Holders, Agnes is an expert PV auditor. She is also a recognized PV trainer. Her extensive industry experience includes nine years in PV & MI roles at Bayer Inc. Agnes is a member of the Drug Information Association (DIA) as well as a member of the Canadian Pharmacovigilance Network.

She holds an MSc degree in pharmacology and toxicology.  

As Vice President, Europe at Veristat, Dr. Barceló will drive the strategic European growth plan and expand services through organic and acquisition growth initiatives to ensure customer success. Veristat will continue to broaden its customer base and clinical operations, biometrics, pharmacovigilance, and regulatory operations throughout Europe. Montse will ensure that all growth maintains the high-quality scientific standards that the Company provides clients across its North American, Taiwan, and European geographies.

Dr. Barceló received her medical doctor degree from the University of Barcelona in Spain in General Medicine and Surgery. She started her pharma services career as the General Manager for Spain at Clinical Data Care, a Swedish data management CRO. Later in her career, she joined the Scandinavian CRO, TFS, as Regional Managing Director, ascending to the role of Global Chief Operating Officer, where she was responsible for 18 countries globally and more than 600 clinical research professionals across 23 affiliate locations.