R&D Acceleration Case Studies

Development of Clinical Portal for real-time view into clinical performance

Project was developed for a major biotech company and incorporated planning, detailed views of investigator performance and scenario modeling.  Solution was rolled out over 5 studies and resulted in demonstrable improvements on study delivery prediction.

Integration of late-stage clinical processes into seamless submission.

Project integrated the planning activities of late-stage Clinical and Regulatory for a major pharmaceutical company sponsor.  Initiative integrated clinical planning [e.g. trial and planning, patient recruitment, data management, and report writing], with regulatory activities [e.g. submission planning, publishing planning] to develop a cohesive process.  Initiative yielded an 11% improvement in cycle time and reduced rework.

Development of Project Portal – R&D

Development of project-based portal for major pharmaceutical company.  Project successfully integrated clinical, project management, regulatory and critical issue information into one easy-to-use portal.  Successfully rolled out over 30 project teams.

Critical Prioritization initiative for Must Do projects

Led development of R&D ‘Must Do’ project initiative for major pharmaceutical company. Developed selection methodology, critical alerting for senior management, and communications strategy to convey priorities around the organization.

Identification and Selection process for Investigators

Developed identification and selection for a high profile Phase III study conducted by major pharmaceutical sponsor.  Led all communication, prioritization and selection activities using an analytical interview-based selection process.  Result was 30 additional sites recruited for a difficult-to-recruit study among many competing clinical trials.

Global Clinical Capacity Management System

Partnered with top 10 pharma companies head of clinical operations, analyzed the business needs and jointly developed a real-time process and system to evaluate and execute the optimal approach to managing a large number of multi-site, multi-country clinical trials.  This resulted in line managers gaining the ability to see their clinical trial and resource capacity real time and optimize their country specific responsibilities.

Deliverable Based Resource Management Approach

Developed a “Deliverable Based” resource management system designed around standardized algorithms, complexity factors and scheduling anchor points.  The resulting approach continues to provide J&J with faster analysis and alignment of data in managing the business of drug development.

Top Pharma New Product Development Process

Led a team of drug development and commercial team members to design a new approach to managing the Drug Development process. The core design is being expanded to other recent acquisitions and the model of how to do business.