Early phase drug development pathways may seem rigid, but there can be some flexibility when it comes to the steps you take in certain phases. Some studies often associated with Phase 1 do not necessarily have to be done before starting Phase 2. The reverse is also true, in that some elements of Phase 2 […]
Is your organization starting clinical research and looking for a way to conduct it in a safe, timely, and cost-effective manner? Is the program designed to meet regulatory requirements for the multiple jurisdictions where you plan to request market authorization? Consider conducting your early clinical development in Canada. Many biotechnology and pharmaceutical companies have moved […]
When it comes to drug development and manufacturing, pharmaceutical companies rely on CROs and CDMOs to streamline the research process. After all, developing a new drug or drug variation is a highly regulated and lengthy process. Partnering with a CRO with pharmaceutical CDMO capabilities offers numerous benefits, including access to clinical equipment and facilities and […]
If your organization intends to develop drugs for the Asian market, you may need to repeat Phase 1 studies in regions outside of North America or Europe—or with your current CRO if they have the right participant populations. This research can help you determine whether the drug’s pharmacokinetics are the same in different ethnic groups. […]
Toxicity studies during drug development are essential. They play a vital role in helping drug sponsors make informed decisions. Your organization wants tests supporting data-driven decision-making to help move your drug development further along toward manufacturing and clinical trials. Your CRO partner can leverage the preclinical data in planning for and designing your first in […]
When choosing a contract research organization to help with your company’s clinical research, you must ensure they have the right capabilities. Ideally, your CRO also offers pharmaceutical CDMO capabilities for over-encapsulation and creating blinded study materials. These are vital during clinical trials. A CRO/CDMO that can run the study and create the dosage form can […]
Drug development is a highly intricate and complex process. It requires a thorough plan. However, it doesn’t have to be complicated, and you don’t have to go about it alone. With an experienced contract research organization (CRO), you can get the help you need to navigate the requirements. The first step in the drug development […]
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, […]
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 […]
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 […]
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 […]
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 […]
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 […]
If your organization is moving to clinical trials, it’s a good idea to partner with a contract research organization (CRO). However, you will want a CRO that also has the capabilities of a contract development and manufacturing company. Partnering with a CRO that offers CDMO pharma services during early clinical development can mean a much […]
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 […]
Large molecules that have recently emerged in biopharmaceutical drug products are prone to generating unwanted immunogenicity-targeting therapeutic drugs. This can impact their safety and efficacy profile, given the fact that the drug is seen as a foreign entity, despite efforts to humanize the active component. Given the complexity of the molecules, there is a regulatory […]
Recruiting clinical trial participants is hugely influential for the entirety of your drug trial. Entering the recruitment phase of any trial might seem straightforward on paper, but the reality can be very different. The recruitment process can directly impact your trial timeline, as well as the proposed budget of the trial. It influences the tools […]
Over the past few years, the drug development landscape has evolved. Where it once emphasized blockbuster drugs that were developed in-house by large pharmaceutical companies, the industry is moving toward a more inclusive paradigm centered on the consumer that includes personalized medicine, orphan drugs for rare diseases, new clinical trial models, and the growing use […]
Whether you are starting early clinical development or considering Phase 1 clinical trials, you will likely want to partner with a contract research organization or contract development and manufacturing organization. Here are some key factors to look for, whether you are outsourcing a specific aspect of your ophthalmic drug development program or partnering with an […]
Clinical trials involving the central nervous system (CNS) require a high level of clinical expertise due to their complex nature. CNS drug trials require specific processes in areas such as participant eligibility and operational conduct. One of the critical areas that must be analyzed in CNS clinical trials is cognitive testing using a driving simulator. […]
Efficiency plays a key role when conducting clinical trials. As your company develops new pharmaceuticals, you want to move from one stage to another as smoothly as possible. When collecting data in early clinical development and preparing for manufacturing, there are many variables to consider, including the drug delivery method. Find out why liquid-filled capsules may be the way to go for your next drug development project.
Developing central nervous system drugs can come with complex early clinical development. There are strict regulations to navigate, first in human clinical trials to conduct, and many other considerations. Partnering with a contract research organization can help take the burden off your organization, utilizing the expertise of their trained teams and the necessary resources to streamline your drug development cycle and get your drug to the manufacturing stage.
What resources should you look for in a contract research organization partner if your company is starting a new drug development cycle? Whether you are in early clinical development or already heading into CNS clinical trials, having a CRO in your corner is essential. Your drug development cycle can be streamlined and more efficient with the right resources, such as trained staff or Phase 1 clinical trial units.
Choosing the right CRO for your drug development process can be a challenge. If your organization is looking for ways to save time and money, consider partnering with an integrated CRO/CDMO. Keeping the same partner from lead candidate selection through to early clinical development including manufacturing can have many benefits. Is an integrated CRO/CDMO right for your next drug development project?
Finding potential participants for first in human clinical trials can be challenging if your organization doesn’t have the proper experience. By partnering with a contract research organization, finding the participants you need for your study can be much easier and more efficient. With access to databases and trained staff who know how to advertise and screen potential participants, partnering with a CRO can ensure participant safety and proper data.
If you are performing CNS clinical trials, there is a good chance that you will need to determine the impact of the medication on a person’s driving ability. It’s common to test for this, and several methods have been developed over the years. If this is your first CNS trial, you may need to know […]
What comes next after your drug discovery and safety assessment phase is nearly complete and you have secured funding? What are the relationships your company needs to build to continue your drug development program? What do you need to get into first in human clinical trials successfully? From partnering with a contract research organization (CRO) […]
You’re ready to enter early clinical development. All you need now is to find a clinical research organization that can handle the project you have in mind. However, finding the right contract research organization to meet your needs be a challenge. It comes down to matching your requirements with the capabilities and areas of expertise […]
As a biotechnology or a pharmaceutical company, your on-site capabilities for clinical development may be limited. From small firms to large firms, there are always gaps that need to be bridged. Whether it’s regulatory compliance hurdles or challenges in early clinical development, your company may encounter significant roadblocks that could prevent continued work on any […]