Inside CIS

People
Management Team
Subject Matter Experts

Features

Our CalcPartner service is staffed by GP experts, ensuring the integrity and compliance of your calculations.

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Subject Matter Experts

Amy VanDeCar
Senior Director, Commercial Compliance and Government Programs
As Director of CIS’ Commercial Compliance and Government Programs area, Amy consults in the areas of commercial and government contracting, government pricing calculations and compliance. Her expertise includes Class of Trade development, validation, and maintenance; calculation and procedural audits; policy and procedure review and/or development; and government programs compliance assessments.

Amy’s industry experience includes chargebacks, membership, government pricing calculations, and business/pricing analysis of commercial and government contracts. Her background as a GP analyst, systems implementer, and auditor allows Amy to thoroughly understand the compliance needs of pharmaceutical manufacturers, and she has worked with branded, generic and biotech companies both large and small.

Amy holds an MBA from the University of North Carolina at Chapel Hill’s Kenan-Flagler Business School and a bachelors degree from American University.
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Clarissa Crain
Managing Director, Commercial Compliance
As Managing Director of US Commercial Compliance at CIS, Clarissa oversees commercial compliance engagements across a multitude of areas within US commercial compliance including transparency, sales and marketing, commercial and government contracting, government pricing, and overall corporate compliance. With over 8 years of life sciences experience, Clarissa pulls from both her background in US price strategy, pricing analytics, commercial operations, and market research to assist clients in ensuring meaningful compliance. Working with clients to develop, implement, and maintain internal process improvements and appropriate organizational infrastructure, Clarissa utilizes her breadth of expertise to ensure appropriate consideration of compliance requirements.

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Chrissy Spicer
Director, Commercial Consulting Services
Chrissy Spicer is a Director of Commercial Consulting Services at Compliance Implementation Services with a focus in U.S. commercial, transparency reporting, and government program compliance. With over 12 years of industry experience, Chrissy specializes in providing risk management and consultative services within the areas of corporate compliance, commercial and government program operations. In this way, Chrissy is responsible for conducting assessments to identify, evaluate and mitigate risk. She works with clients to provide tailored solutions for developing, implementing and sustaining corporate compliance programs. Specific to technical solutions, Chrissy has assisted with the development of policies and procedures, business requirements, and providing ongoing subject matter expertise during a system implementation. Chrissy has earned a BS in Management Information Systems and Accounting at Drexel University and an MBA in Pharmaceutical and Health Care Marketing from St. Joseph’s University.
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Judy Fox
Director, Commercial Compliance
Over the past 12 years, Judy has amassed diverse experience in the pharmaceutical industry in the areas of compliance, regulatory affairs, commercial operations, quality assurance and inventory management. As a Director of Commercial Compliance at CIS, Judy has lead our Federal and State Compliance and Reporting and Sample Accountability service offerings. Judy works with clients in implementing Aggregate Spend Solutions including spend and disclosure initiatives and the development and implementation of corporate compliance programs. Judy is responsible for conducting audit and assessments, developing policies and procedures and developing and conducting training programs. Judy’s work included system validations and implementations. Judy is a board member of the PDMA Alliance.
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Linda L. Schock
Director, Government Programs

Linda as over 20 years of industry experience ranging from distribution, pricing, Managed Care and Government contracting, reimbursement and Patient Support Programs. Linda consults with a variety of CIS clients regarding the impact of Healthcare Reform which includes compliance, methodology, systems and processes reviews. Linda also oversees CIS’ management of Government Statutory Pricing calculations through client use of CIS’ CalcPartner™ solution. Moreover, Linda ensures client compliance in the development of pricing calculations and strategy for all government contracts, including but not limited to Average Manufacturer’s Price (AMP), Best Price (BP), Medicaid Rebate Per Unit (RPU) and 340B Public Health Service ceiling prices. Linda received her undergraduate degree from San Jose State University. She is based out of CIS’ West Coast office.

Dave Rice, Commercial Compliance
Director, FSS Contracting & Pricing
Dave Rice is the Director of Federal Contracting at CIS. He has over 25 years of diverse pharmaceutical industry experience including FSS Contracting, Business Development, FSS Compliance, Pricing and Contracting, Finance and Auditing. His expertise in these areas has contributed to the success of numerous companies participating in the Federal Government market.

Prior to his work at CIS, he worked at WSI, Pharmacia, Pharmacia & Upjohn and The Upjohn Company, where he held key positions in auditing, pricing and contacting, Federal Government Compliance and Federal Government Business Development.

Dave is a past Chairman of the AMSUS-Sustaining Members (Association of Military Surgeons of the United States). The organization brings together private healthcare industry representatives with key Department of Defense, Department of Veterans Affairs and U.S. Public Health Service decision makers.
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Don Russell
Director of Government & Commercial Services.
Russell joins CIS after spending nearly 11 years at King Pharmaceuticals where he held various positions, with the most recent being senior manager of government contracting. He was responsible for all aspects of government contracting including Medicaid, State Pharmaceutical Assistance Programs (SPAP), and State Supplemental Programs. Prior to King Pharmaceuticals, Russell held over 19 years of management positions at United Coal Company where he gained valuable experience in contract administration, inventory management design and implementation and product purchasing analysis.
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BILLY GRIMME
Project Manager, Global Clinical R&D
Billy has five years of experience in the biopharmaceutical industry, with clinical and regulatory experience in global clinical site monitoring, standard operating procedure review, gap analysis, and process harmonization. He is skilled in global process improvement and harmonization consulting engagements and is dedicated to developing and implementing management solutions that enhance the speed and efficiency of client’s processes while enabling implementation of these processes among employees.

Before joining CIS, Billy worked for four years as a clinical research associate, with increasing levels of seniority, and one year as project assistant at PPD. In his time at PPD, he was involved in a two-year long process harmonization initiative and training development initiative. He holds a Bachelors of Science degree in Biological Sciences from North Carolina State University. 
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TIM KRZEMINSKI
Director, Project Management and Audit Services
Tim assists CIS business development in promoting the depth of expertise of CIS’ audit services consultants and assists clients in realizing the monetary and efficiency benefits of value-added audits across their business. He is also  responsible for assigning consultants to existing projects, supervising staff utilization, and managing project financials across CIS. 

Tim joined CIS after spending more than nine years at Ernst & Young in Philadelphia where he was a senior manager in their risk consulting practice. He has a strong background in risk advisory/audit and has worked with many of CIS’ existing pharmaceutical clients. Mr. Krzeminski graduated with bachelor’s degrees in economics and management from Gettysburg College in Gettysburg, Pennsylvania. He is a certified internal auditor (CIA) and certified fraud examiner (CFE).
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Sandra Wall
Director, Government Programs
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Suma Kallurkar
Senior Manager, Global Clinical R&D
Suma has worked in the pharmaceutical and biotechnology industries for over 10 years in the areas of Clinical R&D, marketing, business development and operations. She possesses strong pharmaceutical industry experience in Policy and Procedure Documentation, including facilitation of cross-functional teams to create/revise Standard Operating Procedures (SOPs) and Policies, coordination of cross-site groups to establish and ensure harmonization of procedures, and management of controlled documents.

Suma currently supports a pharmaceutical company’s R&D Quality Assurance and Compliance department in the development, revision and maintenance of SOP and Policy documentation, working closely with senior management. Suma has earned a Bachelors degree in Biology from Duke University and an MBA from the University of Virginia.
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ERICA BROOKS
Senior Compliance Manager, Global Pharmaceutical Manufacturing and GMP
During the last 15 years in pharmaceutical manufacturing, Erica has worked as quality control manager, technical facilitator, a quality control/assurances supervisor, and an analyst. She has had the responsibility of leading the Quality Control Laboratory. She also has quality assurance and regulatory affairs operations experience at three manufacturing sites. She has a diverse experience in final dosage manufacturing and active pharmaceutical ingredient manufacturing. She has managed and sponsored global harmonization projects and lean manufacturing projects.

In addition, Erica is certified in Root Cause Analysis and CAPA systems, as well as Lean Manufacturing, Six Sigma, and Design Excellence.

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Karen Chaney
Clinical Compliance Consultant
As a CIS Clinical Compliance Consultant, Karen manages a variety of client projects involving adherence to and knowledge of Good Clinical Practice (GCP) guidelines. Karen develops, implements and evaluates GCP training programs, audits and assessments, quality programs, policies and procedures. Karen also assesses and advises clients regarding clinical trial spend and the Physician Payment Sunshine Act. Her experience includes Trial Master File (TMF) development, audits and archival, global process harmonization, establishment and assessment of Quality Management Systems (QMS) and risk remediation plans. Prior to joining CIS, Karen worked at an international Contract Research Organization (CRO) as a Principal Research Coordination Specialist. She received her undergraduate degree from North Carolina State University.
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Yasmeen Muhammad
Senior Consultant, Global Pharmaceutical Manufacturing and GMP
During the past nine years, Yasmeen has worked as a quality assurance associate, quality control lead chemist and quality control analyst. She has worked at two manufacturing sites where she gained quality experience in GMP and GLP practices, data review, document control, batch record review, change control, SOP writing, training, investigative writing, CAPAs, as well as FDA inspection readiness. Yasmeen is also certified in the 5S Lean System and Root Cause Analysis.

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Kristin Williams
Clinical Compliance Consultant
Kristin Williams joined CIS from Inspire Pharmaceuticals, Inc. where she was a Clinical Research Associate. Kristin has strong industry experience in all aspects of clinical development including protocol development, monitoring, SOP development, training, data management, and process harmonization. While at Inspire, Kristin played an integral role in the development of an investigator-initiated trials program, including development of the application, process, and training of clinical and medical affairs staff. Kristin’s experience also extends to federal and state compliance regulations and she advises clients on aggregate spend and the Patient Protection and Affordable Care Act as it relates to the Physician Payment Sunshine Provision. She holds a Bachelors of Science degree in biology from Lenoir-Rhyne College and is also a registered U.S. Patent Agent.
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