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...
Biopharma Startups Succeed More Often with the Right Expertise
By Julie Rosenberg, MD Biopharma startups often need senior-level expertise as they navigate the drug development process. However, hiring a full-time executive can be financially out of reach. These companies...
Flexible Resourcing Strategy for Life Sciences in 2025
A flexible resourcing strategy for life sciences can help manage the uncertainty of the upcoming year. This year, layoffs, mergers, and acquisitions have shaken up the life sciences industry. If...
Regulatory Changes in Life Sciences: 5 Key Updates
Working in life sciences is exciting because of the ever-changing landscape. In a constantly evolving industry, new regulations and legislation continuously emerge. As a life sciences professional, staying current is...
Case Study: Program Management & Cross-Functional Teams
A virtual company submitted their first IND and needed an effective and nimble project team to oversee their clinical program, develop clinical documents for regulatory submissions, and support overall business development.
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.