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 can prepare study designs that make sure the process meets your needs, and the studies are effective. When developing a new drug, you need the journey to be efficient, safe, and thorough. That’s why a top-notch CRO will help you develop strategies at the start from the get-go.
Pharmacology Studies
It’s impossible to predict the future, but a good CRO can come close by providing pharmacological testing services for the preclinical stage of your drug development project. These specialized studies, including tests like liver biopsies, bone marrow aspirates, and serial CSF samples, offer lenses into the future of your new therapeutic entity. A CRO that connects you with highly qualified scientists and analysts to perform these tests can help predict the biological effects of your new drug. Preclinical services should set you up for success, and pharmacology studies can help you better understand the road ahead.
Safety First
As you begin first-in-human trials, you want to be sure the transition from the preclinical to clinical step occurs as smoothly as possible. This includes ensuring you understand the impact of your new chemical entity or biotechnology-derived product on vital organ systems. That way, when first-in-human drug testing begins, physicians can safely conduct clinical trials with the appropriate design and execution techniques. The best CROs will offer this safety pharmacology as part of their complete development programs. That means they can help you meet all the regulatory guidelines that are in place to keep safety a priority.
Preparing for the Next Step
Moving from the preclinical stage into the clinical stage is a big step for your drug development project. With the right CRO partner at your side, your Phase 1 clinical trials hit the ground running. A CRO handles manufacturing, and testing is accelerated because they can start producing the clinical supply of your new drug and get the first-in-human trials started sooner. Ultimately, a CRO you can trust is a great partner to take you through the preclinical stages and beyond, so your organization can benefit from a productive and quality drug development cycle and essential resources like Phase 1 clinical trial units.
About Altasciences
As a mid-sized contract research organization, Altasciences understands drug development is a complex process. The Altasciences team can help make the process smooth and streamlined for their partners. Altasciences is an integrated CRO with pharmaceutical CDMO services with more than 25 years of research experience. Pharmaceutical and biotechnology companies can count on the innovative, integrated approach Altasciences uses for preclinical studies and clinical trials, including bioanalysis and manufacturing. When your organization partners with Altasciences, it gains the team’s expertise in a variety of therapeutic indications study types, including experience in first-in-human clinical trials and CNS clinical trials. The CRO/CDMO offers access to resources including highly trained and experienced staff, more than 580 beds, and a recruiting database of over 400,000 potential participants.
Partner with Altasciences for your preclinical and clinical research at https://www.altasciences.com/
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