Operational Program Management

Operational Program Management

Big picture thinking with rigorous attention to bench-level detail

We can help you in any number of ways, from assay selection to NDA/BLA submission. As much or as little as you need.

Clients often engage us to assist with assay selection, to recommend biomarker assays, how to use the resulting data, to perform statistical analysis or to map out a comprehensive bioanalysis activity timeline for your drug development program. Our comprehensive planning considers your internal capabilities and capacity, budget, timeline, and critical path activities. We can recommend external resources to meet your needs.

Additionally, we can also act as your internal expert when managing a CRO or vendor, using our analytical knowledge and background experience to oversee your program strategy.

Services offered include, but are not limited to:

  • Operational management for small molecule, large molecule, oligonucleotide, cell and gene therapy (ATMPs), as well as biomarker programs
  • Assay selection
  • Budget planning
  • Project planning and execution
  • Identification of strategic partners and CROs
  • Manage a third-party laboratory or vendor, provide vendor technical evaluation, scope of work development, project management and regulatory compliance oversight

Contact us today and let us know what challenges you are facing.