When working with an experienced lab, Dose Range Finding (DRF) studies are used as an early detection warning system for your compound. Typically in DRF studies we are pushing dose levels to identify correlating toxicity. This is the time to pinpoint the highest possible repeat dosage level in a 7-14 day study, which in turn will be used to extrapolate dosage levels for your GLP study. The last thing you want is to have unexpected outcomes or unknown toxicity that adversely affects your GLP studies. Once you are in the GLP stage you want the study to run as smooth as possible.
Your DRF studies should be used to not only generate data for GLP dosage level selection, but to work out all the “hiccups” that could come with running in vivo studies. When looking for a partnering research lab, you will want to consider a few things: previous experience the lab has had with these types of studies, the lab’s policy on collaboration with the client and the size of the lab.
First, look for a lab that has experience running a wide range of toxicology programs. Working with an experienced team will help you troubleshoot study events before there is a problem. The scientific team at Attentive has a wealth of knowledge gained from many years of conducting DRF and GLP studies, which can be applied to complicated study issues to identify the best possible approach to keep your study on track.
Attentive scientists have conducted countless studies and are able to anticipate how the study is going to go. Before we even start the study, we outline and plan each stage of the program. We visualize studies before they run and assess, as best we can, what some of the possible pain points that could be encountered on your study are. We have solutions A, B, C and D in our back pockets so if one of those pain points happens, we already have solutions ready to bring to you, the client.
This leads right into the next important thing to look for when working with a lab. The access you have to the scientist and team working on your project. You should want to work with a lab that focuses on real time collaboration to be able to adjust to study related issues and provide you, the client, the flexibility of monitoring critical phases of the study.
We recently conducted a study with a client who took full advantage of the investments we’ve made in our remote monitoring capabilities. The client was virtually present for all doses during the DRF and was able to visualize the clinical observations in real-time, which allowed us as a collaborative team to adjust the study plan without delay. This not only helped generate valuable data, but saved the client time and money by having direct access to the scientist and the team working on the project.
Lastly, you will want to look at the size of the lab. Not only will this help ensure you are part of the team and are allowed access to the scientist working on your project, it is also more cost effective to work with a smaller lab.
DRF studies are part of the journey to find the necessary information about your compound, which will be used to effectively set up your critical GLP studies. If you are working with a big lab, they might be too rigid, find it challenging to change on the fly or have too many levels to navigate before an agreement is achieved. This leads to delays and adds time and money you don’t often have. Companies, like yours, are trying to budget their entire program and want to partner with smaller companies that produce high quality results and help you avoid paying the premium of big labs.
The Attentive scientists have all come from other CROs bringing with them the knowledge of the big lab environment in how they run programs but have adapted some aspects to make our procedures better and more efficient. We are committed to providing high level of quality while passing on cost savings to our clients through our approach to business.
Working with Attentive you get more attention to quality than you get from big guys, but at the cost of the little guy. With Attentive you are part of the “A” team and your involvement is important to the success of your program. You won’t just get a report at the end of your program, you can be there every step of the way, fully involved and able to ask questions throughout the study process.
Give us a call today or schedule a virtual tour and work with a contract research organization that will ensure your DRF studies set your project up for success.