No start-up company can contain all the expertise necessary to turn a molecule into an approved drug. Hiring full-time clinical development staff is costly and time-consuming and usually not necessary at the early stages of development. Zymo can assess your needs and show you how to get to the next stage: whether it is to file your first IND, develop and/or manage your Phase I-III trials, or set up FDA meetings for each stage of drug development.
Zymo brings not only decades of hands-on expertise in drug development, but also the attitude you need to be successful. We are passionate about our work and treat your product as if it were our own, from avoiding unnecessary costs to assuring the quality you need to get your drug through regulatory approval.
Established Biotech/Biopharma Companies
Somehow there are always more great programs or products than there are people available to run them. Prioritizing is a critical discipline for growing and established firms, but sometimes a modest expenditure can give an outsized return. Zymo can help evaluate these options and then step up to the plate with cost-effective studies that can quickly assess an opportunity that might otherwise be missed.
In addition, when senior staff need to focus on other priorities Zymo can step in to fill a short- or medium-term need in your organization to keep your projects moving ahead with maximum efficiency at any point in a program from start-up to data analysis and clinical study report writing.
Finally, sometimes an outside, critical eye can help assess priorities and problems. Zymo’s depth and breadth of knowledge and experience in drug development can help management make the right decisions about which project to
Whether you need a medical monitor to oversee an ongoing clinical trial, a clinical lead to provide medical expertise to your project team and oversight and guidance to a clinical program, or content development expertise for protocol development and/or regulatory submissions, Zymo Consulting Group has the experience and expertise to support or supplement your existing staff to assure timely execution of your clinical plans and to meet corporate or regulatory deadlines.