Altasciences

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 rep...

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 t...

When your organization starts early clinical development for a new drug, it can be helpful to bring on a contract research organization as a partner. Finding the right CRO partner for the drug development process is critical for getting the results you need and streamlining the project overall. Your organization may want to consider a full-service CRO that can take you from lead candidate selection to clinical proof of concept, including bioanalysis and manufacturing, reducing the time and money it takes to develop and test the new drug. Regardless, the CRO your organization chooses to partner with should have access to these five resources to help drug development run smoothly. Trained Staff The CRO should have trained staff to take care of all your needs. This must be staff members who are familiar with regulations and designing, conducting, and reporting on clinical trials. If you have partnered with a CRO to help with recruiting study participants, the staff should know which re...

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 given project. Therefore, you’re faced with a choice: continue internally—even if you’re not fully equipped to do so—or partner with a contract research organization. Electing not to work with a CRO can come with many pitfalls that may ultimately cause delay to your drug development. Here are the reasons why partnering with a CRO for your next drug development project is invaluable. The On-Going Challenge of Regulatory Compliance Throughout the drug development cycle, your organization may find it difficult to navigate certain aspects. One of those areas could be regulatory requirements during each stage...