Our pharmacovigilance professionals understand the complexities of drug safety and risk management, as well as how they need to grow from early drug development through to commercialization.
Your needs are variable—sometimes you need a full-time resource, while other times you need flexible support. Whether you’re looking for on-demand short- or long-term support with individuals or teams, we can help.
We have depth of experience supporting clients to clarify goals, capabilities, timing, and gaps to present you with custom-crafted solutions. We leverage your internal team or outsourced providers and fill any gaps you may have.
Our safety medical leads and operational expertise range from designing your risk management plans to building your internal safety infrastructure to monitor, evaluate, and report adverse events during clinical development and post-marketing.
We can lead or support the development and execution of risk management plans / REMS and conduct risk/benefit analyses. Our case processing professionals effectively monitor, evaluate, and report adverse events during your clinical trial and post-marketing.
Our professionals are skilled at building fit-for-purpose safety infrastructure as well as objectively selecting, managing, or closing out drug safety activities provided by your CRO or vendor.
Meet with a member of our team to find the right solutions for your life sciences company.
Talk to UsIndustry Insights
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 for pharmaceutical and biotechnology companies, enabling them to navigate the complex regulatory landscape and mitigate risks associated with drug safety. Pharmacovigilance Consulting Ensures Drug Safety […]
Industry Insights
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 must be strategic about when and where they should bring in external drug development advisory. Whether a biopharma startup is looking for interim leadership, regulatory […]
Industry Insights
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 you’re responsible for hiring, you need a way to maintain productivity with limited resources during this economic downturn. A flexible resourcing strategy can help you […]
Industry Insights
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 imperative for your career. Here are five critical regulatory changes that you need to understand: #1) Concurrent Submission and Review of Oncology Products As you […]
Industry Insights
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.
Industry Insights
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.
