Ensuring Safety In Drug Development
By Julie Rosenberg, MD Safety in drug development is critical, and a Pharmacovigilance (PV) consultant can help you with this vital work. PV consulting has emerged as a crucial service...
Case Study: Cross-Functional Team Management
An emerging oncology and rare disease company with little internal infrastructure was experiencing rapid growth after demonstrating potential efficacy in phase 1 of their first oncology indication and was moving towards a fast-track submission. As the company worked to expand their internal infrastructure, they needed functional expertise across disciplines to ensure development success.
Case Study: Data Management Support
A global pharmaceutical company had over 4 active INDs, with more than 20 clinical studies in phase 2 and phase 3 in oncology indications. Full-service CROs were utilized for each program, but after turnover at both the client company and the CROs, a decision was made to reassign the studies to a central, US based staff. This new study allocation lead to a lack of continuity, internally and externally, and the new team was having trouble getting up to speed on the clinical status of the programs. In parallel, a business decision was made to internalize data management operations.
Case Study: Clinical Development Guidance and Support
An emerging oncology company that relied heavily on outsourcing was moving into phase 3 of their first clinical program. They needed a plan and processes to develop and sustain proper oversight of key functional areas of their phase 3 program to prepare for a successful marketing submission and for future programs in their pipeline.