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Strategic Consulting

By powering a significant portion of the world’s clinical trials, Medidata has developed unique expertise in R&D change management and business process optimization. Available strategic services include:

Risk-based monitoring

Reduce trial costs and increase site quality by developing a comprehensive strategic monitoring program based on effective risk assessment and categorization. By leveraging historical data analytics, you can develop meaningful risk indicators that provide early signal detection.

Study Design Optimization

With optimal protocol and study design—based on quality by design—you can streamline and enhance trial processes and overall decrease your study cost, complexity and timelines.

Outsourcing and CRO governance

Reduce costs and risk through optimal outsourcing governance, from honed strategies for CRO selection to data-driven management processes.

Business transformation

Drive best practices and optimal study design through business transformation, change management and analytics and benchmarking to improve performance and measure success. 

GET STARTED

Medidata’s services team and Services Partners can help get your trial up and running quickly.

Questions?  Please contact us.


FOR MORE INFORMATION

Service Description

Medidata Global Library Optimization Service

Medidata Risk-Based Monitoring Service

Medidata Study Design Optimization Service

THE STRATEGIC CONSULTING TEAM

Medidata’s Strategic Consulting Services team is comprised of seasoned industry experts with vast experience acquired within Medidata and in pharmaceutical companies, CROs and strategy consulting firms. Leading the practice areas are highly experienced executives with extensive industry understanding.

Rajesh Patel

VP, Strategic Consulting Services

As vice president of strategic consulting services, Rajesh Patel is responsible for leading a global team of highly experienced industry consultants, enabling Medidata customers to maximize the value of their investments through strategic and transformative services.

Rajesh brings over 25 years of diverse clinical research and development experience spanning positions in clinical operations, data management and consulting services.

Prior to joining Medidata, Rajesh held various key leadership positions at eTrials, Covance, Procter & Gamble, Novartis and GlaxoSmithKline with his primary focus on the application of leading-edge technology solutions for clinical trials.

Kyle Given

VP, Strategic Consulting Services

As vice president of strategic consulting services, Kyle is responsible for the Strategic Monitoring consulting practice. With over 20 years in clinical research, Kyle is a recognized expert in operational efficiency models including strategic monitoring.

Prior to joining Medidata, Kyle was executive vice president at Research Pharmaceutical Services (RPS). During his tenure, he worked alongside leading large and mid-sized pharmaceutical companies to design, implement and enhance global site management and monitoring organizations through processes, technologies and advanced business analytics. Prior to RPS, Kyle led the US clinical research operational team at Sanofi.

Medidata Principal Stacey Yount

Stacey Yount

Managing Principal

As strategic consulting services managing principal at Medidata, Stacey is responsible for the Data and Analytics Consulting Practices. She specializes in the transformation of operational organizations through data assets and innovation such as machine learning. With 20 years in clinical research, Stacey is an expert in data management, pharmaceutical efficiency, clinical development, and CRO operations and innovation.

Prior to joining Medidata, Stacey was vice president of Data Management and Late Stage Transformation and Innovation at Covance. During her tenure, she was accountable for transforming the data management, project management and alliance management organizations as well as integrating the Late Stage operations of the central laboratory and clinical development businesses. Stacey was responsible for driving innovation that reduced the cost and cycle time of drug development through an optimized data flow. Prior to Covance, she was head of Global Clinical Pharmacology Operations at Eli Lilly, where she also held roles in data management, statistics, six sigma and clinical operations. Stacey holds a Masters degree from Indiana University, and since 2012, has been a guest lecturer at Indiana University School of Business

Ken McFarlane

Principal Engagement Consultant

Ken is a principal engagement consultant at Medidata with over 16 years of experience in clinical research. Ken spent most of his clinical career as a clinical operations monitor, project manager and director across PPD, MDS Pharma, RPS and working directly with large and mid-sized pharma customers. In stragetic consulting, Ken specializes in study planning and study oversight solutions, helping customers in organizational design, enhancing business processes and implementing efficiency models.

Marco Amorim

Principal Engagement Consultant

Marco is a principal engagement consultant at Medidata with over 12 years of experience in the development, implementation and use of clinical systems. Marco has spent many years leading a team of implementation consultants that worked closely with large and mid-sized pharma and biotech companies to efficiently deploy new technology. His experience working across a diverse set of customers gives him a unique vantage point into the operational challenges that Medidata’s customers face every day. Marco has a passion for solving these problems and helping Medidata customers reach their goals.

 
Diane Carozza

Diane Carozza

Senior Engagement Consultant

Diane is a Senior Engagement Consultant at Medidata and responsible for leading the Study Design Optimization and Feasibility offerings and is a subject matter expert in study and site qualification/selection and the optimization of business processes relative to technologies that support clinical operations. Diane posseses 25 years of diverse experience in the pharmaceutical industry where she held various roles across R&D, Clinical Operations and R&D Information Systems. Prior to joining Medidata, the majority of her career was spent in Clin R&D and Clin Ops at Pfizer and subsequently Allergan where she supported Therapeutic Operations and the Site and Study Management organizations in R&D IS and was a lead contributor on the TransCelerate Biopharma Shared Investigator Platform and Investigator Registry initiatives. Diane is an SME in the development and implementation of web-based investigator portals and was the Director of the InnovoCommerce clinical portal solution where she focussed on developing technical solutions to optimize busines processes and create efficiencies for sponsors and sites for top pharma and CRO clients.

 
Ann Cochrane - Senior Engagement Consultant

Ann Cochrane

Senior Engagement Consultant

Ann is a Senior Engagement Consultant at Medidata and responsible for leading the Clinical Study Optimisation offerings and is a subject matter expert in systems implementation, analytics and data management, change management and the optimization of business processes relative to technologies that support clinical operations.

Ann has over 25 years of pharmaceutical industry experience where she held various roles. Prior to joining Medidata, after leadng biometrics teams and project managing clinical trials through a number of different roles, then managed and implemented complex global technology projects.

Ann also has spent time in the oil and gas industry providing consultancy services in global project management and implementation of centralized processes and systems.

Since joining Medidata, Ann worked in concert with account managers to develop and execute on sales strategies, building sponsor relationships, presenting products and the value of Medidata’s solutions directly to Sponsors in the mid-market EMEA area, before joining the Strategic Consultancy team in 2016.

Cheryl Lichtenthal - Senior Engagement Consultant

Cheryl Lichtenthal

Senior Engagement Consultant

As a Senior Engagement Consultant at Medidata, Cheryl is responsible for leading the Strategic Monitoring offerings and is a subject matter expert in Risk Based Monitoring, clinical research, process improvement, and quality assuance. Cheryl has over 25 years of experience in the pharmaceutical industry. Prior to joining Medidata, Cheryl worked primarily in clnical R&D as a Senior Site Monitor at Wyeth-Ayerst and Sanofi, and as a Senior Regional Manager and Associate Director Process Project Manager in Quality and Continuous Improvement at Sanofi.

Cheryl's experience also includes Pre-Approval Inspection efforts for two submissions, FDA inspection support, and active participation in the Site Qualification and Training initiative for TransCelerate BioPharma, Inc.

Cheryl is an SME in the implementation of Strategic Monitoring solutions and holds a Masters Degree in Nursing from SUNY Health Science Center in Syracuse and an MBA from University of Central Florida.

Scott Meryweather - Senior Engagement Consultant

Scott Merryweather

Senior Engagement Consultant

Scott is a Senior Engagement Consultant at Medidata, Scott is working on Strategic Monitoring offerings and is a subject matter expert in Risk Based Monitoring, clinical research, process improvement, and quality assuance. Scott has approximatley 20 years of experience starting as a Study Coordinator before moving into the pharmaceutical industry. Prior to joining Medidata, Scott worked in clnical R&D at Sanofi as a Senior Operational Clinical Project Manager, managing both CRAs and Projects a Senior Clinical Project Manager and as a Senior Site Monitor.

Scotts previouse experience also includes being a Subject Matter Expert and a working member in TransCelerate BioPharma, Inc. workstreams including Shared Investigator Platform and eSource workstream.

Scott has a Bachelors of Science in Biology from the University of Utah.

Michelle Stump

Senior Engagement Consultant

Michelle is a Senior Engagement Consultant at Medidata specializing in Data and Analytics. She specializes in the transformation of operational organizations through data assets and innovation such as machine learning. She brings over 17 years of experience in the pharmaceutical industry, including big pharma, CRO and Central Laboratories, with leadership and technical expertise in global data management, clinical trial management, clinical monitoring, investigator and client training, strategic planning, road mapping, technology and innovation.

Most recently, Michelle was the External Applications Portfolio Lead for a market leading Central Laboratory, where she was the business owner for a multimillion dollar portfolio of products for data integration, analytics, as well as investigator and client portal technology.

Michelle leverages her distinct global background and breadth of experience bringing a unique point of view to her professional endeavors to build meaningful, innovative alliances, partnerships and strategies.

Tracy Johnson - Engagement Consultant

Tracy Johnson

Engagement Consultant

Tracy is an Engagement Consultant at Medidata and a top-performing leader with over 18 years of experience leading global, cross-functional teams in increasingly demanding clinical operations, clinical data management, clinical systems, and life sciences technology roles.

Prior to joining Medidata, Tracy held a Clinical Data Management Systems Manager position within Amgen’s Global Study Operations team where she led a global portfolio resourcing operational efficiency initiative responsible for off-shore vendor transition of a 175+ clinical study portfolio, including creation, definition, and execution of work stream structure, study team transition, and training and mentoring of internal and vendor staff.

In Strategic Consulting, Tracy specializes in study planning, study oversight, and data and analytics solutions, leveraging her extensive portfolio of diverse clinical industry experience to deliver focused consulting services and drive transformative change and real-world value. In her role as an Engagement Consultant, Tracy functions as an integrator between business needs and technology-driven solutions, partnering with customers to identify and creatively help solve business problems of diverse scope ultimately shaping solutions, designing and helping to re-engineer critical business processes ultimately transforming the way our customers adopt Medidata technology and associated best practices.

Tracy holds a Master of Science in Health Sciences in Clinical Research Administration from George Washington University.

John Barberini

Senior Engagement Consultant