Our Leadership Team
Transparency isn’t just what we do, it’s who we are. The TrialAssure team brings a wealth of experience from some of the world’s most formidable pharmaceutical, biotechnology, and SaaS organizations. Sponsors trust TrialAssure’s team of experts to help define regulatory processes, not just follow them.
Kelly Vaillant is a Senior Director of Global Transparency Strategy & Compliance with extensive experience in all aspects of Clinical Development, with particular focus in Clinical Trial Disclosures, and Data Transparency, Clinical Operations, Project/Program Management, and Clinical Data Management.
At TrialAssure, Kelly is responsible for providing transparency strategy, consulting, providing technical expertise on regulatory requirements and health authority registries, assisting clients and colleagues in navigating regulations, and bringing an innovative “Design for Transparency” approach to ensure alignment across the organization.
With more than 20 years of experience, Kelly was previously the Global Head of Clinical Trial Disclosure and Transparency at Gilead Sciences and held leadership positions at Novartis, Amgen, and Pharmacia. Additionally, he holds a BSc from the University of Alberta with a specialization in Neuropsychology.
Zach Weingarden is a Senior Product Solutions Manager with more than ten years of experience in the healthcare and CRO arena. Zach has managed software implementations in fast-paced and demanding healthcare, research, biotech and pharma environments. He is adept at analyzing business workflows and aids in the design, configuration and testing of TrialAssure software that aligns with organizational needs and objectives.
Zach has demonstrated ability to manage application developers, technical services representatives, and client analyst teams to ensure projects met strict deadlines and adhere to budget constraints.
Recently, Zach was recognized as Most Valuable Millennial by Corp! Magazine. He holds a Master of Science in Biomedical Engineering concentrating in Biotechnology and a Bachelor of Science in Industrial and Operations Engineering.
Mohamad has more than 25 years of global experience in Information Technology (IT), Enterprise Business Systems, and digital transformation. As Chief Information Officer (CIO), Mohamad is responsible for overseeing the operational and strategic aspects of the company’s IT infrastructure, Business Process Transformation, and product development. Prior to TrialAssure, Mohamad held several global leadership positions in the industry and led multiple IT and business systems transformation initiatives. He has established governance over key enterprise business processes, as well as led the formation and implementation of cloud strategy.
His expertise extends to ISMS areas, including technical and quality certifications. As member of the Forbes Technology Council, Mohamad is proficient and experienced at emerging technology needs within the pharmaceutical industry, including regulatory requirements, and IT infrastructure controls to support clinical trial transparency.
Mohamad holds a Master of Science in Computer and Information Systems from the University of Detroit Mercy, and a bachelor’s degree in Computer Information Systems from The Detroit College of Business.
Raina Agarwal has over 12 years of experience in clinical trial transparency, medical writing and medical information domains, including a depth of expertise in clinical trial registrations, results posting, maintenance, and data-sharing requirements for ClinicalTrials.gov, EudraCT, EU PASS, and other mandatory international registries. She has successfully led a number of anonymization and redaction projects required for EMA Policy 0070, EMA Policy 0043, Health Canada PRCI, FOIA and voluntary data-sharing requirements for journals, CSDR initiatives, and company websites, among others.
As Senior Manager of Transparency at TrialAssure, Raina is directly involved in developing standard operating procedures, working practices that adhere to clinical trial transparency regulations, and conducting on-site workshops and training to effectively communicate best practices and efficiencies to sponsor teams and new clinical trial disclosure colleagues. She has been instrumental in evaluating the impact of new and evolving regulations on the sponsors’ studies and submissions. Collaborating with TrialAssure strategists and developers as an SME, she proposes system enhancements and tests new and upgraded features in the TrialAssure REGISTRY and ANONYMIZE software. Raina is committed to providing robust transparency services and technology platforms to sponsors, enabling them to achieve compliance.
Raina has presented on multiple occasions in DIA-Clinical Trial Disclosure Community Meetings and conferences. In addition, she recently published an article in the European Medical Writers Association Journal on evolving clinical data-sharing regulations like EU CTR 536/2014, HC-PRCI submissions and EMA Policy 0070. Raina holds a Master’s in Pharmacy from Birla Institute of Technology and Science, Pilani, Rajasthan, India.
As Associate Manager of Transparency at TrialAssure, Holly leads transparency projects and processes, ensuring high-quality transparency deliverables are produced in an efficient and timely manner. She also maintains a strong understanding of industry regulations and guidance pertaining to transparency and makes sure projects and deliverables are compliant with regulatory guidelines and timelines. Holly is skilled at anticipating and understanding a Sponsor’s specific transparency needs and can develop solutions and deliverables according to their company specifications.
Holly Curry is a subject matter expert in redaction and anonymization for EMA Policy 0070 and 0043, Health Canada Public Release of Clinical Information, journal publications, and other transparency related regulations.
Holly holds a Bachelor of Science in Business Management from the University of Phoenix.
Jim Balcom is Director of Partnerships and IT Governance with more than 20 years of experience providing services and solutions to the Life Sciences industry. At TrialAssure, Jim is focused on innovation and the development of strategy to enhance our solutions.
In this integral role, Jim contributes to the internal change management strategy, implementation and adoption of tools and enhanced services and processes. Additionally, he initiates concepts for services, products, solutions based on customer needs, and supports the development of applicable use-cases, support planning, and implementation strategy that aligns with customer goals.
Jim holds a Master’s Certificate in Strategic Leadership and Decision Making from Michigan State University as well as a Bachelor in Applied Arts with emphasis on Personnel Management from Central Michigan University. Jim is a member of the Association of Strategic Alliance Professionals.
Alan has more than 20 years of experience within the global pharmaceutical environment, working across development, consultancy and clinical trial transparency and disclosure services.
Alan is a member of the global operations team specializing in markets in the UK and other parts of Europe. He has led the development and implementation of new product strategies on behalf of top pharma in this region. In addition, Alan has successfully worked with these companies to develop outsourcing strategies (technology plus resourcing) that will meet the strict requirements for clinical trial disclosure and reporting to global registries.
Alan holds a Postgraduate Diploma in Information Technology and Society, and a Bachelor’s degree in Physiology and Biochemistry from the University of Southampton.
Lisa James is the Senior Director of Business Operations and Client Relations at TrialAssure. With 15 years of experience, she has extensive experience collaborating with global clients, consultants, KOLs, SMEs, and alliance partners.
As the Senior Director of Business Operations and Client Relations, Lisa leads the global business development, proposals and contracts and alliance partnership teams. Lisa is passionate about innovation and serves on TrialAssure’s Innovation Leadership Team.
With a result-oriented approach and a focus on teamwork and coaching at all levels, Lisa has organically built a talented and motivated team who partner with internal and external clients to establish long-term mutually beneficial partnerships.
Lisa has a Bachelor of Arts in Management and Society and a second major in Psychology from the University of North Carolina, as well as certificates in Leadership and Business Acumen and Business Essentials from the University of North Carolina Kenan-Flagler Business School and is a certified LSS Green Belt. Lisa was recognized by the Triangle Business Journal in 2014 with its 40 Under 40 Leadership Award and in 2015 with its Women in Business Award.
Kelly has more than 20 years of clinical research experience in the pharmaceutical and CRO arenas holding positions within clinical data services, clinical operations, regulatory compliance, and project management departments. Kelly has initiated long-term partnerships with biotech companies and large multinational pharmaceutical organizations, developing strategies to support their short- and long-term goals. This support extends to due diligence activities, alliance partnerships and establishing resource and technology strategies to meet the emerging needs in the area of data transparency.
As the Executive Director, Global Business Operations and Strategy, Kelly is responsible for all client accounts and oversight of the project management function, , maintaining a 97% customer satisfaction rating, Kelly has helped establish relationships within various lines at the client end to ensure a harmonized approach to service delivery.
Kelly completed undergraduate degrees in biology and mathematics leading to a Master’s in Clinical Research Design and Statistical Analysis from the University of Michigan, and she serves on the University of Michigan School of Information (UMSI) External Advisory Board (EAB).
Sam Venkat, CPA is the Chief Financial Officer at TrialAssure, with 20 years of experience in corporate finance, accounts, costing, treasury management, and contracts.
Based in our Canton, Mich. headquarters, Sam serves at the head of overall accounting and finance functions. At TrialAssure, Sam and his team prepare monthly, quarterly and annual financial statements under US GAPP, implement cost controls and contract management, monitor budgetary control, and more.
Sam earned his CPA from the California Board of Accountancy.
Prasad M. Koppolu has more than 25 years of experience across a diverse group of industries, including technology, transportation, energy, and professional services, and has held senior leadership positions in business development, operations, and research and development, among others.
As COO, Prasad has global responsibility for business development, business operations, strategic partnerships and alliances, infrastructure, and global resource management. He is responsible for defining and implementing strategic direction for the organization and optimizing effectiveness within the company’s overall business strategy. Prasad has demonstrated a successful track record of senior leadership in complex, global, customer-focused organizations. Additionally, he is leading infrastructure expansion to support the company’s projected future growth and drive improved global connectivity.
Prasad earned his masters’ degrees in industrial engineering and mechanical engineering from Clarkson University in New York and the Indian Institute of Technology, respectively.
Michelle Gayari has more than 20 years of experience in clinical research, including career highlights at Pfizer, where she worked across Phases I-III studies for all indications of Lyrica® and several other CNS compounds.
As Executive Director of Global Operations, Michelle leads the global technical functions for all service offerings, including transparency, regulatory, and all data-related services. Her teams are experienced in supporting a variety of submissions for both small and large pharma. Under her leadership, MMS teams have supported all transparency regulations, including the FDA’s Final Rule, EMA Policy 0070, and Health Canada PRCI.
With a focus on teamwork and mentoring at all levels, Michelle has organically built a talented and motivated team of colleagues internationally. Michelle earned her BS in Statistics, Mathematics, and Psychology from Central Michigan University.
Daria Fellrath is Manager of Human Resources at TrialAssure, with more than 10 years of expertise in organizational development and human resources across multiple industries.
She possesses diverse business and cultural experiences in multiple countries and industries, knowledge of three languages, as well as deep understanding of Human Resource Management, Organizational Development and Learning & Development. A detail-oriented, creative team player, Daria has a unique ability to diagnose organizational needs, develop vision and strategy, and lead the implementation of appropriate solutions.
Daria holds a Master’s Degree in Human Resource Management and Organizational Development, as well as a Bachelor’s Degree in Language and International Trade from Eastern Michigan University.
Uma Nathan is Head of Operations (India) at TrialAssure, with more than 30 years of experience in administration, finance, and HR.
Under her leadership, TrialAssure is able to grow its team internationally, across multiple time zones to provide services and support on a near 24/7 clock.
Uma earned a Bachelor of Arts in Economics from Delhi University and completed the Management program for Woman Entrepreneurs from the Indian Institute of Management, Bangalore.
Sandra Drake is a Manager, Corporate Quality Assurance at TrialAssure, with over 20 years of progressive management experience in the biomedical industry.
With strong leadership and team-building skills, Sandra supports efforts to establish, maintain, and continually improve the Integrated Management System (IMS) – ensuring compliance to ISO standards and regulatory requirements. As an analytical thinker, Sandra ensures organizational compliance to legal & regulatory requirements, as well as monitors quality, information security, data privacy, and external audits. Previous to TrialAssure, Sandra held leadership positions at Pfizer and Esperion Therapeutics.
Sandra holds a Bachelor of Science in Medical Technology from University of Michigan-Flint, an MPH in Laboratory Practice in Epidemiology from University of Michigan, and a PhD in Pathobiology from University of Minnesota.
Ray Clark is the Senior Manager of Business Development at TrialAssure. Ray has over 20 years of experience in consultative sales, business development, and sales team management.
As the Senior Director of Business Development, Ray partners with potential customers to accurately understand their transparency needs and provides consultative advice that assists Sponsors in achieving their goals. Ray leads discovery meetings to determine the most efficient and effective solution for technologies and services to solve a customer’s business needs. Ray proficiently manages business requests and timelines to ensure Sponsors’ needs are met on time and effectively.
Ray holds a Bachelor of Arts in English from Siena College.
Gina Bennett has extensive experience in regulatory transparency and disclosure services, including EMA Policy 0070 and Health Canada PRCI redaction and anonymization regulatory requirements.
As Senior Transparency Specialist at TrialAssure, Gina provides Sponsors with high-quality transparency deliverables on deadline based on a strong understanding of transparency guidelines and regulations to ensure compliance. In addition, Gina advises Sponsors on the anonymization of personal information and confidential business information within their submissions, including the development of anonymization and redaction rules according to the latest regulatory guidance.
Gina holds a Bachelor of Science from Samford University. Prior to joining TrialAssure, Gina served as a Senior Redaction Specialist at Synchrogenix, a Certara company.