Altasciences

One of the most significant milestones in drug development is moving to first in human clinical trials . It’s the first opportunity for a sponsor to evaluate the new chemical entity or biologic’s impact in humans. You might need to assess the safety and tolerance of the drug, determine pharmacokinetics, identify early pharmacological activity relative to exposure level, assess any observed effects on subsets of study participants, and evaluate therapeutic outcomes in a smaller group of patients that suffer from the targeted disease. Here are six steps to help your organization reach its goals. Which Regulatory Interactions Are Necessary? Preparing for regulatory interactions during early clinical development is crucial. You will need to clarify any uncertainties that regulatory agencies might have when looking at your FIH program. The trial design should show a strategy for proving safety and proactively addressing any risks. This includes clinical conduct and reporting. Use a well-...

If your organization is recruiting for first in human clinical trials , you may want to consider partnering with a contract research organization. The right CRO will have the expertise needed to properly recruit for your Phase 1 clinical trial and beyond. Partnering with an experienced CRO means you can get the advertising experience necessary to recruit, as well as access to databases of potential participants. Here are some of the ways partnering with a CRO for your clinical trial recruitment can be beneficial. Creating a Recruitment Strategy Qualified CROs know how to create a proper recruitment strategy for your clinical trial that helps you achieve your goals. The earlier in the drug development process your organization partners with an experienced CRO, the easier it will be to create a successful recruitment strategy. Education is also a critical component, and integrating it into your recruitment strategy is crucial for ensuring patients are well-informed throughout the proce...

One of the most vital steps of early clinical development is choosing which contract research organization you will partner with. Selecting the right CRO is an essential aspect of your drug development program, especially since it can affect critical decision-making. The CRO you choose should share your vision, understand your goals, and offer flexible, integrated services to support your organization along the way. Here are some important things to consider when choosing your organization’s CRO partner. In Some Cases, the Size of the CRO Can Determine Flexibility Would your organization benefit more from a large CRO or a smaller one? With a bigger CRO, you might have access to more resources, but a smaller CRO might be able to offer more personal contact and allow your organization to provide more input in the process. Or a mid-size CRO could be more flexible and able to adapt their processes to match your needs. No matter your preference, be sure to partner with a CRO ...