In a previous blog, we discussed Investigational New Drug (IND) enabling studies, the matrix of tests that must be conducted before a new therapeutic can be administered to the intended population, focusing on study design, implementation and potential outcomes and impact on the timing of clinical trials. We also focused on the importance of selecting a CRO that as well as having the experience and expertise to help steer the drug through the complex maze of tests, also works in partnership with their clientele to overcome challenges in real time as the programs progress.
Over the past 2 years of COVID related volatility we have seen a changing global landscape, not just in our industry, related to supply chain issues. We have seen challenges in scheduling studies using specific test systems due to their unavailability and we have used our experience to work with our clients to best address this by looking at alternatives to allow the conduct IND studies in a timely manner. We do this by advising on test system selection and keeping a close eye on the regulatory authorities view point on those selections. For example, challenging the selection of a certain test system based on the “well, that’s the way we’ve always done it” to one of “what is the viable alternative?”.
Attentive Science has evolved with these changing views to build on our experience by thinking alternatively. We have also built up a strong network of industry expert partner companies that allow us to provide a complete IND package. We know that working with 5 or 6 CRO’s to complete your IND package can be challenging both in terms of time and effort. We take that extra pressure from you and manage the relationships in order for you to succeed.
It is taking these extra steps, as well as our personal interest in working with you as part of your team, that has allowed us to grow. New clients come to us by “word of mouth” due to our ability to work efficiently and effectively to provide the best quality science to meet your IND timeline. Our repeat clients return to us because of this and the relationships they have built with individual study personnel is amplified. We often receive requests to work with individual scientists and technicians because of these relationships, and we aim to accommodate those requests because it is important to us that you are comfortable.
Let us show you how we conduct the best science in an Attentive way. Call or email us.