White Paper: Recruiting Women for First-in-Human Trials: Tips for Success
Programs that need to include women in their FIH studies will find that successful enrollment of women is achievable; however, it requires a concerted effort, with the correct strategies and proper support. In the following pages, we explore the challenges in recruiting women for FIH studies and present a set of practices that have proven successful towards improving the recruitment rates of women for these studies.
White Paper: Outsourcing Analytical Testing For Biologics – A CRO’S Perspective
Biologics are complex large molecules derived from living organisms or manufactured from cells, and they have inherent structural heterogeneity. Indeed, proteins, given their chemistry, are the “most structurally complex and functionally sophisticated molecules known.”1
Thus, the analytical testing required to support Chemical, Manufacturing, and Controls (CMC) activities of biologics is highly sophisticated, and is becoming more so as the modalities of biologics grow more complex (with antibody drug conjugates, conjugate vaccines, PEGylated proteins, fusion proteins, gene therapies, and cell-based therapies).
Frontage is a full-service CRO that enables biopharmaceutical and generic companies to advance their molecules from preclinical and clinical development, through commercialization. We believe partnership is what turns service into solutions. Our comprehensive laboratory services include analytical testing, product development and CTM manufacturing, DMPK, and bioanalysis Our clinical service portfolio includes early stage clinical services and biometrics.
This wide range of offerings enables us to provide a variety of solutions to your drug development challenges.