CSA

CSA

Enabling more insightful clinical trial reviews

Monitoring and reviewing clinical trial data is a critical step to ensuring the success of any clinical development plan. But today’s manual processes can often result in errors, compromising data quality and incurring costly study delays.

Medidata Centralized Statistical Analytics (CSA) provides immediate insight into clinical trial site performance and data quality. An integral part of Medidata Clinical Cloud, CSA integrates data from different systems and provides a comprehensive report for each subject, making it easier for teams to detect and track critical data changes throughout trial execution. 

The advanced and robust statistical algorithms in Medidata CSA provide a comprehensive scan of a clinical trial database for inconsistencies across data domains, sites and patients. With templates for SDTM data, automated processes can be setup so that every clinical study submitted to the FDA can have a study grade calculated for data quality. The overall study grade can be a measure of overall data consistency, and be compared across sponsors, studies, indications and disease areas. Individual site grades can be used to measure data quality within the site, and identify studies and sites at high-risk for procedural problems and data errors.

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 24 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. 

As strategic consulting services principal at Medidata, Kyle is responsible for the Risk-based Monitoring Consulting Practice. With over 20 years in clinical research, Kyle is a recognized expert in operational efficiency models including risk-based 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

As strategic consulting services principal at Medidata, Stacey is responsible for the Analytics, Business Intelligence and Benchmarking Consulting Practices. With over 19 years in clinical research, Stacey is an expert in clinical operations, data management, pharmaceutical efficiency 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 is a principal engagement consultant at Medidata with over 14 years of experience in the leadership, management and monitoring of all phases of clinical trials. Ken spent most of his clinical career as a monitor, project manager and director, working closely with large and mid-sized pharma customers. Ken has experience in organizational design, enhancing business processes and implementing efficiency models.

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.

 

Lauren is a senior engagement consultant at Medidata with over 20 years of experience in the clinical operations management and monitoring of all phases of clinical trials. Lauren spent most of her clinical career at Pfizer where she managed large, complex process improvement projects that created global solutions generating significant impacts on quality, productivity and patient safety. Prior to joining Medidata, Lauren held a key role with Knowledgent as a consultant focusing on business process optimization.

Diane Carozza

Diane is a senior engagement consultant at Medidata and possesses over 20 years of diverse experience in the pharmaceutical industry where she held various roles across R&D, Clinical Operations and R&D Information Systems. Diane has substantial experience in the development and implementation of web-based investigator portals across the pharma industry. Before joining Medidata, Diane was a business relationship manager at Allergan where she supported Therapeutic Operations and the Site and Study Management organizations and was a lead contributor on the TransCelerate Biopharma  Shared Investigator Platform and Investigator Registry initiatives.

 

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