Posts

5 Reasons to Conduct Early Clinical Development in Canada

By
Image
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 their initial clinical research to Canada to get earlier access to first-in-human data, high-quality clinical research, and reliable study participants. Plus, it can help keep costs down. Here are some of the advantages your organization can expect when moving your early phase clinical research to Canada. Start First-In-Human Trials Earlier Access to FIH trials in Canada is slightly different than in America. You can start FIH clinical trials before obtaining Investigational New Drug approval. That means your contract research organization can conduct study participant recruitment and screening at the s
Post a Comment
Read more

Flexibility in Timing for Phase 1 Clinical Studies

By
Image
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 can actually be performed by you or your contract research organization during Phase 1. This can help you access vital bioanalysis data earlier in the drug development process. As Phase 1 studies have become increasingly complex, early access to trial results and comprehensive data related to safety and drug pharmacology can help better inform decisions. This information can also help support funding opportunities and solidify your overall program. Here are four things you need to know about the flexibility you have during Phase 1 clinical trials. Early and Clinical Pharmacology Study Timing During a drug development program, exploratory therapeutic studies are required milestones, a
Post a Comment
Read more

The Basics of Choosing a CRO/CDMO for Your Drug Development Program

By
Image
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 the ability to help your business scale at a faster, more cost-effective rate. Now that partnerships are becoming the norm across the pharmaceutical manufacturing landscape, choosing the right CRO/CDMO partner requires a careful approach to ensure you find the right, most experienced option. Here are a few of the top factors you should look for when selecting a CRO/CDMO partner for your next drug development program. A Wealth of Experience in Drug Development and Manufacturing One of the most important considerations to make when choosing a CRO/CDMO is to search for a partner with a wealth of experience in drug dev
Post a Comment
Read more

How Asian Ethnobridging Trials Can Shorten Drug Development Timelines

By
Image
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. If your organization wants to demonstrate biosimilarity in drug products between Asian and non-Asian populations, consider performing Asian ethnobridging trials. When you decide to incorporate ethnobridging into your project during early clinical development , you can save time and help your budget. Here’s how.  What Is Ethnobridging? Ethnobridging means using a local target population for a study during Phase 1. Instead of needing to repeat studies in the target region, your organization can recruit participants in “global” safety and efficacy trials using a Phase 1 ethnobridging strategy. The Phase 1 development won’t have to be repeate
Post a Comment
Read more

6 Things to Know About Repeat-Dose Toxicity Testing

By
Image
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 human clinical trials . Here are six things you need to know before starting repeat-dose toxicity testing.  How Long Does a Repeated-Dose Toxicity Test Take? Once the design of the repeated-dose toxicity test is finalized, the tests usually range from 2 to 6 weeks. Using bioanalysis to identify biomarkers and other key translational endpoints during preclinical toxicology studies can help reduce the risk to clinical study participants and greatly benefit your research. It helps to have a team well-versed in selecting species, treatment group size, frequency, duration of treatment, administration r
Post a Comment
Read more

7 Benefits of a CRO That Also Offers Over-Encapsulation and Blinded Study Materials

By
Image
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 drastically reduce your timelines. Here is everything you need to know about over-encapsulation and why it might be worth partnering with a CRO with CDMO services and expertise in this area for your next clinical study.  What Is Over-Encapsulation? Over-encapsulation is a cost-effective, popular technique involving blinding a solid dosage form into a capsule shell. This eliminates bias from comparative clinical studies while maintaining the study’s efficacy and integrity. Without adequate blinding, clinical trial participants may be able to tell the difference between a placebo and the real drug. This cr
Post a Comment
Read more

4 Ways a CRO Can Help During the Preclinical Drug Development Process

By
Image
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 process is the preclinical stage. With a reliable and efficient CRO, you can confidently make it through the preclinical stage and move on to the early clinical development phase. Here’s how.  Strategic Guidance and Protocol Development While you can partner with a CRO for stand-alone services along with preclinical and clinical studies, such as bioanalysis, biostatistics, data management, and project management, the best ones offer complete development programs. Think of the very beginning of any program as the planning process. In the discovery and preclinical stages, you need to lay out your strategy for the entire project. You need a CRO that
Post a Comment
Read more