Choosing the right CDMO partner for your development candidate can make or break your program and your company. Our team can help outline the right manufacturing strategy, present options and negotiate with potential vendors to ensure that you achieve the best possible outcome. We can then provide oversight and management of your selected vendor and pull in additional expertise when needed.
Companies advancing a first program need expert guidance but often do not need a full-time clinical team. We can provide strategic development guidance around your first in human trial, navigating challenging biomarker plans or potential toxicity issues. We can then put in place an operational strategy to ensure the study runs on-time and on-budget and provide an interim team of development and operational experts that you can rely on to get the trial done.
Early-stage companies may not need full time administrative support but there comes a time in every calendar when you need an extra pair of hands on an interim basis. Planning for important meetings like JP Morgan, supporting development of a board of directors calendar, navigating an office or lab move, planning an investigators meetings. Consider us your expert SWAT team.
A quality culture requires building the right foundation and this is where our team has extensive experience. We spend time to understand the nuances of your program and business to implement the right quality management system. We then provide ongoing support to the team to make sure that execution is seamless with appropriate documentation in place.
We are an experienced group of drug development professionals with extensive experience advancing novel programs into and through first in human clinical trials. We are passionate about helping innovators to advance programs to clinical proof of concept without having to spend time and money hiring a full team of internal experts. We work together as team to ensure that your project has the skill sets required to succeed.