So, you’ve had an idea, you’ve developed a product, and you’ve had a breakthrough that can potentially provide everyday people with significant improvements for their aesthetic concerns. The only thing standing between the release of your product is the fact that you have to go through pre clinical and clinical trials. At DeNova Research in Chicago, IL, our research site is fully prepared to help you streamline your pre clinical services so you can begin the next phase of clinical trials for your product.
What Does Pre Clinical Mean?
Pre clinical refers to the stage of development and testing that occurs before human trials start. The pre clinical process involves several stages to create protocols for initial research that will verify the safety of the product you have developed. While pre clinical trials are not as well-known as clinical trials to the larger public, developers and research understand that pre clinical stages are critical steps that must not be overlooked.
Why Are Pre Clinical Services Necessary?
There are a few reasons why pre clinical services are necessary steps that must be taken to ensure that your product is safe for the general public. For example, it’s a point of fact that funding for your clinical trials will rely on the validity of your pre clinical research. Of course, because organizing all the stages of your pre clinical research can be tough, research sites such as ours are ready to provide pre clinical services to simplify the process so you can focus on the research.
Pre clinical services are important for three main reasons:
1. Assessing Toxicity and Safety
If you have developed a new product or service, the pre clinical stages are important to verify that there are not toxicity and safety concerns. For example, if you have developed a new injectable for cosmetic purposes, research will need to determine if the ingredients are potentially toxic before they are used on human subjects. If you have developed a device for aesthetic purposes, that device will need to be examined to see if it is safe to use and that it has a high likelihood of producing the desired results.
2. Identifying Ideal Starting Dose
All new products and services must have a starting dose that is deemed safe for human use. This is an especially important step, because even if a product is not toxic by itself, an incorrect dose may create toxicity, unfavorable results, or no results at all. Identifying an ideal starting dose that is deemed safe for human use will give you a place to springboard the rest of your research when you begin clinical trials.
3. Planning Initial Human Trials
Your pre clinical stages are also important to plan your initial human trials. Human trials have several stages where each subsequent stage features a wider testing pool to determine the safety and efficacy of a product. However, planning these human trials means understanding the type of population you need to be testing, how long those clinical trials should last, and what factors will determine whether a product has failed.
What Are Common Pre Clinical Services?
Although you may use one or all of the services offered by our research site, it’s still important to understand the different stages you can expect on your path to beginning clinical trials. The most common services include:
Protocol development refers to the portion of your research that will outline the way in which your pre clinical studies will be performed and will identify the goals of your studies, such as verifying the efficacy of a product. Protocol development written by a research site will be drawn up according to the needs of your study so that your pre clinical trials can meet evidence-based medical standards accepted by the FDA. This can be done for all levels of pre clinical studies, from phase I to III.
A large portion of getting your pre clinical trials through to the clinical trial stage is tailoring your research and evidence-based standards to the Regulatory and Institutional Review Board (IRB), which is a board that will review the safety and efficacy of your product. This is one of the most time-consuming tasks of the pre clinical stage as it involves gathering several documents for the IRB to review, including documents related to your most recent research findings.
Validated Scale Development
Evidence-based results rely on the validity of your testing and how well results are collected and documented, which is why validated scale development is so important. Validated scale development involves a series of steps that scale the research of your pre clinical trials, which will help you develop further avenues of research based on the findings of the scale. This portion is especially important when you are scaling your research to larger population samples.
Investigator New Drug Submission
Investigator new drug (IND) submissions are a pocket of bureaucratic paperwork that essentially petitions the FDA to review your current research and allow you to begin the clinical phase of your research. IND submissions are not always necessary, although you are likely to have one if your product is new to the country or newly developed and unlike other products already on the market. The IND submission also allows your research to gain feedback from the FDA and guidance on how to proceed if the FDA does not deem your product ready for human clinical trials.
Investigator Initiated Trial Development
The stage of investigator initiated trial (IIT) development creates the opportunity for your product to be independently researched by investigators who are not associated with your company or the initial development of the product. This is an essential step due to the fact that efficacy and safety standards that are verified by IIT are more likely to be accepted by the wider medical community, which makes it easier for your clinical trials to start.
It’s a point of fact that funding research and clinical trials are expensive work – and unfortunately, there are only so many grants that can do around. If your goal is to have government-funded or independently-funded grants, then it’s important you use a service that specializes in grant writing, which will help award your research the funding it needs to make it through both pre clinical and clinical trials.
Are Pre Clinical Services Always Used?
Yes. Whether your product requires all of these services, or only a few, there will always be a need for some pre clinical stages that need to be observed if you intend for your product to be widely used by the general population. Going through the pre clinical stages will lend your research validity, verify that your research is evidence-based, and allow for better funding for your research and development.
Why Does the Research Process Matter?
The research process is essential when you are developing a new product that is intended to be used on humans. Each stage of research is designed to ensure that the product is not harmful and that it performs as expected to produce the desired results. Research for aesthetic products and devices is more important now than ever before since most patients want to be sure they are using safe products and will achieve the desired results without harm.
How Long Does Pre Clinical Research Take?
You might be surprised to learn that most pre clinical research and trials will take anywhere from one to six years to complete. This amount of time is usually sufficient to verify that the product developed is not harmful and has a high likelihood of performing as intended. Pre clinical research for products that are similar to ones that have already been developed may be shorter since there is already existing research to verify the safety of your own.
However, it can also be the case that your pre clinical research will be locked in a stalemate for a few years if you are having trouble refining your product or verifying that the project is not toxic or harmful. This process may also take longer if you need to go back and refine the product you have developed, particularly for chemical-based treatments.
Does the FDA Verify the Pre Clinical Research?
Yes. The FDA is heavily involved in verifying that your pre clinical research and results are up to Federal law regulations and standards. The amount of verification owed to the FDA may depend on how novel your product is, whether there are similar products already on the market, and how well your documents are presented to review boards and the FDA.
What Is Involved In a Pre Clinical Trial?
If clinical trials are intended for humans to verify a product is non-toxic and safe for use, then it stands to reason that pre clinical trials will involve animal testing. It’s common for many animals to be involved in the initial testing phase of your research. Some pre clinical trials will include mice and rats, rabbits, cats, dogs, and other mammals.
Pre clinical trials that use animals to verify a product is not toxic can happen with both medical and cosmetic products. These pre clinical trials that use animals are intended to refine product development and serve as the first step of convincing the FDA that your product is both safe and effective. Many pre clinical trials often involve testing a product on multiple species of animals since, like people, no two animal breeds have the same genetic factors that could impact trial results.
How Does This Work for Vegan and Cruelty-Free Products?
Recent shifts in testing ethics have made vegan and cruelty-free products more popular, which can make it challenging for the pre clinical portion of product development. However, cruelty-free testing does not necessarily dictate that there are no animals involved. The term “cruelty-free” is not formally defined by the government, which gives clinical trials more leeway to verify safety while still testing products on animals.
For example, cruelty-free products might mean that the final product was not tested on animals during the trial, but that the ingredients of the final product were tested one-by-one on animals during the development process. Cruelty-free testing may also refer to technicalities, such as testing that was done on animals in different countries or by different companies.
Who Are Ideal Users of Pre Clinical Services?
You are likely an ideal user of the services offered by our research site if you have recently developed a cosmetic product or treatment method that needs to undergo all of the pre clinical trial phases for safety verification and preparation for human clinical trials. You may also be a good candidate if you need help creating the documents required for the phases of your research.
Streamline Your Pre Clinical Process Today With Pre Clinical Services
Pre clinical and clinical trials are the last step of your product development, so it’s important to do them right. If you want to streamline your pre clinical process, contact DeNova Research in Chicago, IL to schedule your consultation.
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