Client Background

• Client name: A leading global biopharmaceutical company
• Industry: Pharmaceutical
• Areas of operations: Global
• Number of employees: Over 20,000

Challenge

The customer needed support in data governance, stewardship, and loading (data review, updates, oversight, cleansing, quality, reporting, and remediation) during study start up, conduct, and close out project activities.

Considering there were 170+ studies on the URL in different phases, it was a challenge for the customer to bring all these studies under streamlined processes for different activities. The client faced issues overviewing the study status and activities. Additionally, there were challenges of  understanding and resolving study related issues/discrepancies due to lack of knowledge on product possibilities.

Solution

Wipro provided project URL management, site management, core configuration management, lab administration, process streamlining/improvement for the global pharmaceutical company, including user access and administration services for US, APAC, and other geographical regions.

• Business Process and Operational Data System Support: Helped clinical development operation team with clinical study startup, conduct, and close out.
• Subject Matter Support: SMEs assigned for clinical studies and developer for issues resolution on operational systems and product usage.
• Testing: Author, review, execute, business document and technical test cases and UAT scripts.
• Business Access Management: Enable security management/user roles for systems to access, transfer or create operational data; including data warehouse, clinical trial management systems, project management systems, SharePoint, EDC, and secure FTP.
• Reporting: Generate, review and, support efforts to provide summarizing reports to business end users and management team. Custom reports and report installation on URL.
• Process Streamlining – Supports on development of streamline process for user access, lab and site administration, core configuration, and URL management.
• Product Possibilities: Efficient usage of data standards to reduce study to data cycle. Regular upgrade of EDC tools to enhance advancements.
• Analytics: Systematic statistics data for the discovery, interpretation, and patterns for tracking at different stages that helps customer in effective decision making for any ongoing study activities

Business Impact

The company managed to address issues of R&D clinical information management and data system support for US and APAC region and reaped tangible results.

1. Cost Containment: Around 30% reduction in overall operational cost and achieved first time resolution of >98%.
2. Scalability: Availability of experienced, cross-skilled, and trained health care professionals to create required bandwidth resulted in data optimization and harmonization.
3. Value Stream Mapping: Using Medidata Rave EDC (Tool for quality monitor management; safety event capture; and monitoring and business analytics).
4. Implementation of Quality-on-Quality layer to ensure high standard quality delivery.
5. Electronic Data Capture administration: Support for upgrades of platforms by vendors through creation and execution of UAT scripts. 1400+ RAVE/Inform queries resolved from sites, clinical team and sponsors.
6. Process Excellence: 7-10% overall efficiency increase and improved CSAT and governance.