Stephanie M. Lewko

Stephanie’s engagements largely involve complex data analytics, data trending, predictive data modeling, dashboarding and data management. She has created applications and databases on a variety of platforms to track, manage and report on various types of organizational and procedural data and information. She has also served on numerous Independent Review Organization engagements for life science companies, focusing heavily on transaction reviews, sample selection and validation.

Stephanie has a wide range of experience in pharmaceutical and medical device compliance and strategy including auditing and monitoring, risk assessments and open payment submissions. She also manages projects involving the trending, investigation and management of key regulatory datasets and attributes such as UDI and adverse event reporting.

Areas of Expertise

• Compliance/Regulatory: Stephanie has a wide range of experience in pharmaceutical and medical device compliance including auditing and monitoring, risk assessments and open payment and transparency submissions. She also manages projects involving the trending, investigation and management of key regulatory datasets and attributes such as UDI and adverse event reporting. She also has participated in numerous data privacy and security assessments, focusing on areas such as CCPA and GDPR compliance.
• Data Analytics and Transparency: Stephanie provides complex and advanced data analytic and transparency services to a variety of life science and healthcare clients. Her projects involve data management, dashboarding and trending, analysis and data warehousing, documentation, and production. Stephanie has also been involved in requirements gathering and implementation of custom applications used to address a variety of compliance and regulatory needs.

Life Sciences Matters

• Served as an Independent Review Organization for a medical device company. She was heavily involved in the transaction testing, sample selection and validation as well as creating implementation reports and annual reports including findings on systems reviews and transaction reviews.
• Stephanie has performed data privacy assessments and overseen the creation of data governance programs for several companies. She has created data inventories and gap assessments and drafted policies and procedures as well as data privacy notices.
• Supported the compilation and submission of federal, state, and global transparency reports for a medical device company. Stephanie was involved in the review of numerous disparate data sets, the identification of covered recipients and the validation of data. She was also responsible for the documentation of data analyzed, processes followed, and assumptions made. The resulting reports and analyses served as a basis for the company in automating this process going forward.
• Directed a transparency project to assess existing data sources, data flows, policies, processes, and systems to identify transfers of value between a pharmaceutical company and external healthcare professionals. Created a gap analysis and recommended action plan to prepare and streamline aggregate spend collection and reporting for the Sunshine Act and other State Reporting Requirements.
• Managed a compliance assessment for a global medical device and diagnostic company related to the partnerships created and maintained with distributors, logistics providers, etc. and the associated anti-bribery / anti-corruption risks. Stephanie created a customized database to allow for several multi-lingual auditors to simultaneously and consistently audit against the compliance standards set forth by the company. She was responsible for summarizing daily audit results and reports for the client and compiling various data points and statistics for presentation to management.
• Developed a Needs Assessment database and user interface for a major orthopedic device manufacturer. Trained and supervised the use of the database for over 50 marketing managers in their creation of a Needs Assessment pursuant to the requirements of their deferred prosecution agreement. Stephanie expanded this Needs Assessment database into a tool to provide the client with a variety of capabilities, including but not limited to the creation of work plans and contracts, the tracking of compensation and payments, and the publication of various reports summarizing consulting activities, research and development projects, clinical studies, and grants.