Investigational New Drug (IND) enabling studies are a matrix of tests that must be conducted before a new therapeutic can be administered to the intended population. Depending on the results of each IND-enabling study, the test article could take several different paths to complete the series of studies. In contrast to the common characterization of a drug development “pipeline” being a unidirectional flow from discovery to utilization, a diverse map of potentially failure-prone learning maps must be navigated by scientists with multiple backgrounds. It is vital to find a CRO with the experience and expertise to help steer the drug through the complex maze of tests.
This is where Attentive Science comes in. Attentive will work with you to successfully complete your IND-enabling program. With our significant experience and knowledge of multiple therapeutics and new chemical entities we have come to know what to expect ahead of time. Attentive is a boutique CRO, which allows us to pivot quickly in response to unexpected results. Our Client Calibrated Approach allows us to quickly communicate unexpected challenges to clients, discuss creative solutions and deliver trustworthy data quickly.
We work with clients to evaluate study/test results, suggest solutions for any unexpected results and consider all possible variables to successfully completing IND-enabling studies. We align ourselves with industry experts such as KCAS that will provide the necessary dose formulation and bioanalytical assays support to deliver a full regulatory package.
Since IND-enabling studies have to be completed in a regulated environment and in SEND format, Attentive is fully GLP and SEND ready. Attentive will guide you through the steps and multiple tests needed for your program’s development and deliver data needed to make an informed decision on the best lead candidate selection.
Let us show you the Attentive way. Schedule an executive briefing and/or a virtual lab tour with us today.