Clinical Development Solutions excels at helping pharmaceutical, biotechnology and medical device companies create strategic plans that bring their products to market faster.
In these complex industries, our experts can help clients find the fastest and most cost effective route to take their products from pre-clinical trials through to regulatory approval.
Medical Needs Assessment
We connect you with a broad network of medical experts around the world who thoroughly review and analyze your information to assess and propose the best potential indications for your product candidates. Models for proof-of-concept studies can be included in such assessments.
We can also discuss indication challenges with opinion leaders and clinical practitioners, locally and globally.
Clinical Development Planning
Having prioritized key indications, we can work with you to design clinical development plans that will achieve your goals more quickly and align with your available resources.
We can help design a regulatory and Good Clinical Practice strategy that will result in a filing package that is well-accepted by regulatory authorities and IRBs/IECs around the world, and leads to more timely review and approval.
With this information in hand, we can help you schedule and budget your plans and prepare relevant presentations to potential partners, investors, or management.