Altasciences

If your organization is developing a drug for the first time, you may not know the required regulatory phases. Each is essential to the drug development cycle and regulatory acceptance prior to taking a drug to market. If this is the first time your organization is on its way to first in human clinical trials , whether you are partnering with a contract research organization or not, here is all the most important information you need to know.  The Preclinical Phase The preclinical phase occurs before clinical trials can begin. Researchers must conduct laboratory research and present results to the FDA. The FDA then evaluates and potentially approves the results, paving the way for the clinical trial to begin in earnest. In this phase, regulatory approval is key. If your organization has not submitted results and procedures for regulatory approval in the past, partnering with a CRO with experience may be worthwhile. Phase 1: Safety The first phase of a clinical stud...

When looking for a contract research organization (CRO) with CDMO pharma capabilities, there are certain features you should be aware of. How integrated are the teams? Does information flow freely from one team to the next, or are they stymied by handoffs and delays? What level of manufacturing do they offer? Your organization should address these questions before choosing a CRO/CDMO for your drug development cycle, so here are more details on the top factors to keep in mind.  How Integrated Is the CRO/CDMO? Ideally, all the teams of the CRO/CDMO would be fully integrated with each other. This might mean your organization is assigned a single manager who sees you through the entire drug development cycle, and that teams communicate easily. Find a CRO/CDMO that keeps a database of information that all teams can access, no matter what phase of the development cycle your drug is in. For example, the bioanalysis team would not have to wait for the clinical trial team to ...

It’s nearly time to start early clinical development , and your organization is looking for a contract research organization partner. If you are looking for a fully integrated, all-in-one organization, there are some factors to consider. There are advantages to choosing a full-service CRO instead of partnering with multiple CROs, but a single CRO needs to be able to do everything proficiently. Here are four factors to consider. Do They Have All the Necessary Resources? When a CRO specializes in one discipline, they will likely have the necessary resources to perform that service extremely well. A CRO that can take you from lead candidate selection to clinical proof of concept to commercial manufacturing requires far more resources. The CRO needs the correct medical equipment for first-in-human clinical trials, that are run in their Phase 1 clinical trial units . Ideally, they would have a substantial database of clinical trial participants for recruiting for the study. This can make ...

There has been a recent resurgence in the interest of using psychedelic therapeutic drugs as a potential treatment for mental health issues. The regulatory environment is constantly evolving and has eased some barriers to clinical research. If your organization is considering moving into early clinical development for therapeutic psychedelics, it helps to know a few facts about researching psychedelics to help your organization move smoothly to first in human clinical trials and beyond. How Psychedelics Are Made Generally, psychedelics are either naturally derived or synthetic. Psilocybin, mescaline, and DMT are all naturally occurring, while LSD is fully synthetic. Recent research includes the development of second-generation molecules that will hopefully confer the mental health benefits without potentially unwanted side effects. Types of Mental Health Issues Psychedelics Can Treat A growing body of research shows promise for psychedelics’ potential to treat depression, anxiety,...

If you hope to get reliable, robust data from clinical trials to better inform decision-making, your CRO will need proper handling of specimens obtained from trial participants and samples prepared for lab analysis. Their precise, timely treatment is vital to making go/no-go decisions for a new therapeutic drug. There must be a certainty to the data that comes from proper handling to give the highest accuracy of results to inform decisions. The quality of data depends on rigorous sample management. Integrity needs to be safeguarded at every step. A CRO partner conducting preclinical and clinical studies and providing bioanalytical services must ensure continuity of processes, knowledge sharing, and long-term storage of samples in a centralized location. Here is everything you need to know about choosing the right CRO for your sample management needs. Proper Collection and Storage Conditions There are many different sample types across preclinical studies and clinical trials. The CRO...

In 2017, the FDA declared that driving simulation studies are required for all drugs that may affect cognition. During early clinical development , your organization must determine whether a driving simulation test is needed for regulatory approval. If so, it’s a good idea to partner with a contract research organization that has the experience and resources necessary to carry out the testing. Here are four reasons you should consider partnering with a CRO to conduct driving simulation tests. Recruiting Database Speeds Up Recruiting An experienced CRO will have access to an extensive database of potential participants for your study, from healthy normal volunteers to patients and special populations. These potential participants may have the necessary qualifications for your study or will be easier to screen than if you simply marketed the study to the general population. The CRO can perform the screening process, helping the study get started as early as possible. A recruiting datab...

One of the essential parts of the drug development process is performing bioanalysis . You will need to perform bioanalysis before your drug can go to market, and even before it is tested in humans. You will also need bioanalysis results for regulatory submissions for your drug candidates. As such, it’s best to partner with a contract research organization with plenty of experience in bioanalysis to acquire fast, accurate results. Here is everything your organization needs to know about the importance of bioanalysis. What Is Bioanalysis? Simply put, bioanalysis is a sub-discipline of analytical chemistry. Bioanalysis is quantitative, determining pharmacokinetics, the concentration of drugs, and their metabolites. It can also determine pharmacodynamic biomarkers in biological fluids, such as blood, plasma, or urine. Analyses can also be performed in tissues, which is used to understand the elimination, activity, and toxicity of a drug. How Is Bioanalysis Performed? Before bioanalysi...