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.
Kasim McLain is an industry-recognized expert in United States (US) and European clinical trial disclosure and patient communication regulations and obligations, and is Manager of Transparency at TrialAssure. With more than 15 years of experience in regulatory affairs, medical writing, and the clinical trial disclosures and patient communication spaces in the pharmaceutical industry, Kasim oversees the daily workload of the Transparency team.
Prior to TrialAssure, Kasim was Manager, Clinical Disclosure Lead at GlaxoSmithKline and Parexel. She is an invited speaker and leader passionate about global transparency regulations in the pharmaceutical, biotech, and medical device industries.
Kasim holds a Bachelor of Science in Biology from Roanoke College and a Regulatory Affairs Certification from RAPS.
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.
Ravi Yandamuri is a Principal Clinical Programmer at TrialAssure. With 10 years of experience, he is an expert in SAS programming and the analysis, design, development, testing, and implementation of Clinical Trial Projects in the life science industry.
As an experienced Clinical Programmer with a demonstrated history of working in the pharmaceuticals industry, Ravi is skilled in clinical trial data analysis, data transparency, data sharing, risk-based data and document anonymization, and more.
Ravi holds a Master of Science in Biotechnology from the Stephen F. Austin State University, as well as certificates in statistics, data analysis, and programming from SAS, Coursera, and the Stanford University School of Medicine.
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.
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.
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.
Don F. McLean, MBA
Don F. McLean, MBA
Don McLean is a Senior Manager, Global Marketing and Communications with more than 15 years of marketing and communications experience in the technology, life sciences, healthcare, and B2B arenas.
As an award-winning leader in building authority and increasing impact for brands through integrated public relations, digital marketing, and advertising, Don oversees all marketing and public relations functions, and acts as media contact for the organization. Under his leadership, TrialAssure has achieved pinnacle levels of brand awareness for its leadership in the growing niche of clinical trial disclosure, data sharing, and transparency.
Don was a finalist for the PR News Publicist of the Year Award and received the Platinum Award from the Marketing & Sales Executives of Detroit (MSED). He holds a Masters of Business Administration in Marketing Management from Madonna University.
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.