Altasciences

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

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

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 send

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 more streamlined drug development cycle. This can help keep your drug development project on schedule and within your budget. Here are some of the advantages of partnering with a CRO/CDMO for your Phase 1 clinical trials. Make Recruiting Easier Partnering with the right CRO means you will have access to its recruiting capabilities. Your CRO partner should have access to a database of potential participants. It should have the ability to further segment this potential participant population into specific demographics that are relevant to your trial. An experienced CRO will also know how to properly market to the target population, whether it is thr