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AxxiTrials.com
Axxcelerate Your Trials

About Us

Sponsors and Clinical Research Organizations need tools to securely and effectively communicate with their trial sites resulting in faster, high quality trials. Litéra AxxiTRIALS is a web-based global portal designed to save time and resources as well as to engage, motivate and inform investigators and their site staff for the entire duration of the study.

Litéra AxxiTRIALS is the one-stop-shop for the Sites for everything about the trial. From feasibility, startup, training and certification, ongoing trial to tial maintenance and trial closeout, Litéra AxxiTRIALS serves as the single landing point Study sites and Trial Managers turn to for their trial needs.

Litéra AxxiTRIALS Management Team

Paul Domnick
President

Paul Domnick

Paul Domnick joined Litéra as President in May of 2014. He brings special knowledge about the utility of Litéra’s software products in managing risks in financial services.

Paul was previously Group Chief Technology Officer and Deputy Head of IT for Zurich Financial Services (ZFS), there he was responsible for technology strategy, standards, enterprise and applications architecture across the entire business.

After ZFS, Domnick became CIO of Freshfields Bruckhaus Deringer from the beginning of 2009 until November 2013. At Freshfields, he was responsible for a global team of more than 300, covering all areas in IT & IS such as change management, information security, infrastructure operations and helpdesk support, technical architecture, vendor management, application support, program and project delivery.

Karen Massand
Managing Director

Karren Massand

Karen Massand is a co-founder and board member of Litéra, with more than 26 years in the software and healthcare industries. Previously, Karen was a founding executive of pharmaceutical software company Skila, where she held the top commercial and operational executive positions prior to the successful sale of the company. Her additional industry experience includes commercial operations executive for Salem Health Solutions, a Novant Health healthcare data analytics company, Director at CRM software company Dendrite, and various sales and management roles at Johnson & Johnson’s Ortho McNeil Pharmaceuticals.

Prior to her career in healthcare, Karen was a television news reporter and anchor for CBS and NBC news. She holds BA in Communications from the University of Washington, with post-graduate studies at Wharton and Harvard. Karen is a member of the Board of Directors at Litéra and DrScore, and advisory board member to Axxiem Solutions and Taylor Presentations.

Susan Lewenz
Vice President, AxxiTRIALS

Susan Lewenz

Susan is the founder of Litera AxxiTRIALS and the senior lead on this product. Before joining Litéra, Susan established and ran Axxiem Corp, a successful digital marketing agency focused primarily on the Biopharma space. In 2012, Susan conceived of and created "AxxiTRIALS®", a leading Clinical Trials Community Portal Solution as the result of consistent feedback from the industry. Litéra acquired AxxiTRIALS in 2013.

Susan's career has crossed much of the globe and includes running successful operations in Russia, Ukraine and India. She is credited for bringing companies like Parke Davis (now part of Pfizer), Space Labs Medical and Steris, into the Russian market. Susan also managed product development and user experience for Skila, a knowledge management platform used by nine of the top 10 pharmaceutical companies. Susan has also collaborated with Time Warner and brought both Fortune and Popular Science Magazines to the Russian market.

Fluent in Russian, Susan holds a BS from Michigan State University and an MPP from the University of Michigan, which leaves her squarely in the middle of the cross-state rivalry.

Jeremy Leonard
General Counsel

Joy Heath Rush

Jeremy serves as Litéra’s General Counsel. In addition to managing all legal matters of the corporation, he serves as the Data Security Officer and also oversee business operations.

Jeremy received his B.A. from North Carolina State University, and his law degree from Elon University. Prior to joining Litéra, Jeremy was an attorney for a North Carolina based law firm, focusing his practice on business law and litigation. During the course of his practice, he represented individual and corporate clients in a wide array of subject matters before the North Carolina state and federal trial courts, as well as appellate courts. Among his accomplishments, Jeremy has been recognized for his commitment to pro bono services, and has been identified as a Legal Elite by “Business North Carolina.”

Simon Dandy
Vice President of Research & Development

Joy Heath Rush

Simon is the Vice President of Research & Development at Litéra. He is responsible for the global Research and Development operations.

Simon’s key priority is to maintain the speed and quality of development by providing clarity and direction to our talented developers in the Ukraine, Philippines, Singapore and Vietnam.

Simon started his career in IT as a trainer which is where he developed his understanding of how people use software and developed his passion for simplifying the user experience. While living in New York, Simon became the co-organizer of the New York Word Legal User Group (WLUG) which hosted regular meetings relevant to the Document Production, IT Training, and Applications teams at some of NYC’s largest law firms. Prior to joining Litéra, Simon spent 17 years with the global elite law firm of Freshfields Bruckhaus Deringer (both in London and New York), where he most recently held the position of US Director of IT. His previous position at Freshfields was as Product Manager for the legal desktop.

Vivek Gulavani
Head of AxxiTRIALS Software Development

Vivek Gulavani

With over 19 years of experience in the software industry, Vivek manages all aspects of AxxiTRIALS software development. He establishes and directs the strategic long term goals, policies and procedures and oversees the development, release, and maintenance of AxxiTRIALS.

Prior to his responsibilities at Litéra, he worked as a delivery manager on a variety of other projects, was a project architect for NetLink India Pvt Ltd, and a senior consultant of pension administration software at BenXL Technologies. Vivek received his BS in Mathematics and Masters in Computer Administration from Goa University.

Tapio Schnaars
Product Manager

Dave Rosa

Tapio Schnaars brings 11+ years of experience to the AxxiTRIALS management team and is responsible for all aspects of the product’s management. With expertise in graphic communications, project management and web technologies, Tapio directs the design and development of the platform. He works closely with clients understand their business needs and prioritizes the input for specifications for future product enhancements.

Prior to Litéra, Tapio worked as a design director and client operations manager at Axxiem. Tapio holds a BA in Fine Art from the University of California Santa Cruz and a Master of Arts degree in Graphic Communications Management and Technology from New York University.

Stuart James
Information Security Officer and LSFT/Encryption Lead

Stuart James

In addition to his role as LSFT/Encryption lead, Stuart James manages the information security function at Litera, reporting to the President. He established and maintains the company's information security standards in procedures to ensure compliance with all relevant information security and risk management policies, standards and guidelines. Stuart assists in coordinating contingency plan tests, manages day-to-day hosting of AxxiTRIALS and monitors advancements in information security technologies and changes in legislation and accreditation standards that affect information security.

Prior to joining Litera, Stuart was the CTO of GCrypt Ltd., whose technology was acquired by Litera and became the foundation for the company's Large Secure File Transfer (LSFT) product. Earlier in his career he was the Technical Architect and CISO of Paypoint.net and has maintained his certification as a RedHat developer throughout his career.

Anju Nayyar
Head of Quality Assurance Testing

Anju Nayyar

Anju Nayyar oversees the QA testing of all components of the AxxiTRIALS solution to ensure quality product is consistently delivered. She has built and trained the team, established the QA process and documented the quality assurance procedures. She maintains product quality by enforcing quality assurance policies and procedures and government requirements, as well as collaborating with other members of management to develop new product. Anju prepares product and process quality reports by collecting, analyzing, and summarizing information and trends. She completes quality assurance operational requirements by scheduling and assigning employees and following up on work results. Finally, she maintains quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.

Prior to working with Litera, Anju was the VP of HR and Special Projects at BVG, and GM of IT Consulting at UBICS. She received her BSC and her MBA in Mass Communication from UNZA and is currently pursuing her PhD from the University of Pune in India.

Ken Manford
Senior Director of Sales Engineering

Joy Heath Rush

As the Senior Director of Sales Engineering, Ken is responsible for the leadership of a shared service for the Client Development and Research & Development teams; including prospect and client demonstrations, project management, training, sales engineering, and the smooth end-to- end implementation of Litéra’s suite of products.

Ken brings more than 20 years of experience in the legal technology industry to Litera®; with a concentration on managing cross functional teams and matching business requirements with technology solutions. Prior to joining Litera, his responsibilities, at a top AM Law 100 firm, included Leadership of Training, New Business Intake, Records Management, Document Management, Library & Research Services, and Practice Systems Support.

Nicholas Maviano
Director of Project Management

Joy Heath Rush

Nick brings over 18 years of IT project management and training experience to Litéra. He is the Director of Project Management for Litéra® and is responsible for the project management and implementation of our suite of products.

Nick started his career at IBM, followed by a 15-year career at Sidley Austin LLP, a top AmLaw 100 global firm with more than 1800 lawyers practicing in 19 cities around the world. He was the Director of Sidley’s Project Management Office (PMO) that consisted of 10 Senior Project Managers located in Chicago and London, with oversight for technology and business oriented projects that spanned Information Technology, Financial Systems, Accounting, Marketing, Human Resources and general business operations at the highly esteemed firm.

Melissa Neubert
Manager of Customer Support

Melissa Neubert

Melissa Neubert supervises the Litera Global Help Desk and is responsible for assuring users are provided efficient and timely first and second level support on a 7x24x365 basis. Her job responsibilities include staff scheduling to ensure Help Desk coverage in all geographies, as well as daily management of the Help Desk staff including consultation on performance evaluations, promotions, hiring and disciplinary responsibilities. Melissa monitors the LHD ticketing database, follows up with assigned personnel to ensure timely resolution of problems and invokes problem escalation procedures to coordinate recovery, isolate problem trends and ensure that troubleshooting efforts are completed for recurring problems until permanent solutions are found.

Prior to joining Litera, Melissa held a variety of sales, account management, consulting and support roles at technology companies such as Gateway Computers, Time Warner Cable, Photo Biz and New River Innovation.

Dawn Hudgins
Director of Marketing

Dawn Hudgins

Dawn brings energy, passion, creativity and more than 20 years of experience in marketing and communications to Litéra®. Dawn’s experience includes a variety of global roles in marketing, communications, leadership, key note speaking, training, management development, and organizational development.

Prior to joining Litéra, Dawn worked with the Volvo Group as a Corporate Communications Officer for North America where she was also over Film and Webcasting globally. While at Volvo, Dawn also served as a Culture Navigator. In her early career she owned her own advertising agency where she worked with such clients as Texaco, Diadora, Reebok, Volvo, and the Dallas Cowboys.

Dawn is a certified trainer in: Myers Briggs Type 1 & 2, Franklin Covey Speed of Trust, Barrett’s Value System Type 1 & 2, and FISH Philosophy. She holds a BA in English Media Communications from High Point University, a Mastery certificate in photography & imaging from NYU-Tisch School of the Arts. Dawn is also an international award winning author.

Richard Ward
Director of Client Development, EMEA

Richard Ward

Richard Ward is Litéra’s Commercial Representation for the EMEA region. He is responsible for overseeing the needs of Litéra clients and partners within his region, while seeking new client development opportunities.

Richard is an experienced executive with over 20 years with companies across Europe and USA from a variety of industries. Proven ability to build the plan of the future and lead the execution of the plan through people and teams with excellent processes and appropriate measurement.

Richard’s success is achieved through the fundamental values of respecting all views, honesty, trust and professional integrity.

Pradeep Bhaskar Menon
Director of Business Development, India

Pradeep Bhaskar Menon

Pradeep Bhaskar Menon has been at the forefront of leading new technologies and establishing businesses in India. Pradeep leads Litera’s business in India and is currently our Director of Business Development, India. From the start of his career at HCL, Pradeep has been independently handling businesses’ needs for various companies as an Independent Business head. Before joining Litera, he worked with various organizations like, HCL, DHL, Unicorp, NIIT, Carlson Wagonlit Travels and Cellcast where he held top management positions. Pradeep has also been in account management, customer care and sales training education, having trained over 20,000 individuals during his 32 years of work.