The sooner you can initiate your clinical trials, the sooner your efficacious and safe product will be on the market and be providing healthier outcomes.  An IND, CTN, or CTA is a request for authorization to the regulatory agency, so that you, the Sponsor, can proceed in conducting your clinical trial.

IND/CTN/CTA-enabling studies are advantageous as they:

• Forecast potential safety risks.
• Facilitate the determination of safe initial doses for clinical trials.
• Pinpoint crucial factors for observation and monitoring.

The landscape of the biotechnology and pharmaceutical industry is constantly evolving, driven by innovative ideas, and advancing technology that broadly influence the sector. Agile responses and real-time problem-solving capabilities are crucial to reduce delays and complications. In recent years, funding has become increasingly constrained and, as such, the importance of cost savings, reducing complications, responsiveness, and vigilant budget management has grown more critical. At Attentive Science, we have prepared ourselves to take on the ever-shifting needs of our clients for the Pharmacology and Toxicology section requirements of your regulatory applications.

Your nonclinical safety program map (designs and assays) is dictated by the type of test article being investigated. We adhere to several International Conference on Harmonization (ICH) guidelines including, but not limited to ICH M3(R2), S9, S7A&B and S6(R1). We are committed to addressing our clients' needs at every stage of the process, ensuring we provide the most effective assistance by meeting you at your current point of need. As the industry has evolved, we have worked continuously to build and develop our network of clients and providers for the best experience possible for all involved.

We have found that when it comes to regulatory mandated studies, often what initially brings a client to us may not always be directly related to their IND/CTN/CTA needs. We may have clients come to us for short pharmacokinetic or toxicology studies, only to continue our interaction with them into regulatory required territory to help them evaluate any “alarm bells” that might have been triggered in the early phase studies.

IND/CTN/CTA-enabling studies are a requisite for every clinical trial project. Determining the organization that will be the best fit for you and your particular needs is an important part of the process - but not always an easy one. Here at Attentive Science, we pride ourselves on pursuing a well-rounded approach to being the top tier choice. Our modest size and ease of accessibility allows your requirements to be put in a place of priority. Our team is genuinely invested in the projects we accept, and being involved in your most important projects is something we take very seriously.  Without expertise and an understanding of all the moving parts, it can be difficult for you to keep up with all of the required components. This is where Attentive Science shines and becomes the best choice for moving through the process.

As is often the case with any drug development process, time is of the essence with your IND/CTN/CTA application. We often work with clients who are up against rigid deadlines - we help them achieve the results they need and data required to propel them forward with their project. Many larger companies have an impersonal approach to lead times and an inflexible process, but it is very important to us that we provide a prompt and nimble set of services to those that trust us with their project.

In addition to the rate at which we help our clients through their IND processes, we are also equipped with a vast network of experts and industry professionals that can answer questions and offer a vast array of connections that can be additionally helpful. We are often working with clients that run into a question or a limitation somewhere in their process where we know an individual or group of individuals that likely has the optimal solution or advice. Being connectors and attentive within the industry further aids in our mission to bring a one-stop-shop feel to our clients’ experience.

Having Attentive Science backing your IND/CTA/CTN project and application ensures that the process will be done well, with urgency, and with a communicative and team-like feel that is difficult to locate elsewhere. Most IND packages come with their own specific set of challenges, and having someone on your team to help you navigate areas of uncertainty is invaluable.  Contact Us and let’s achieve heathier outcomes together.