There are a number of factors to consider when choosing a CRO/CDMO partner for your next drug development cycle involving CNS clinical trials. After all, the right CRO/CDMO can help streamline the drug development process. Perhaps, that means help with navigating murky regulatory waters, recruiting for a specialized clinical trial, or manufacturing the drug in-house. One thing is certain—CNS drug development is complex and requires in-depth clinical expertise. As a result, the CNS study team at your CRO/CDMO should have the therapeutic and technical expertise to enhance your processes. Here are some of the factors to consider when choosing your CRO/CDMO partner.
Regulatory Experience
CNS drugs often require more stringent regulations than typical pharmaceuticals. Your organization should partner with a CRO/CDMO that has experience with the regulatory complexities that come with CNS drugs and CNS clinical trials. CNS therapies are often associated with adaptive trial designs. A team with internal protocol reviews can give you IRB-submission-ready protocols. This minimizes the need to make amendments later on and can even shorten your study’s start-up time.
Recruiting Strategies and Resources
Finding potential participants for a clinical study involving CNS drugs can also present a challenge. For example, many potential participants will not meet the inclusion/exclusion criteria for testing psychedelics or other therapeutic drugs. You should partner with a CRO that offers effective and efficient recruiting strategies. The teams should preferably have experience with CNS clinical trials and know how to market the trial. A database of potential participants can also help streamline the recruiting process overall. Most of all, these resources and strategies should serve to meet your target milestones reliably.
Ability to Conduct CNS Clinical Trials
It takes proper resources and experience to conduct CNS clinical trials. Is your CRO partner familiar with driving simulators or studies for potential abuse? Do they have the resources to carry out those specific tests? Do they have Phase 1 clinical trial units where they can conduct the study? Can they assess the incidence of abuse during the clinical studies or information leading to overdose? They should also be able to study the addictive effects of other medications and recreational drugs. Access to the proper resources is critical when assessing CNS drugs.
Manufacturing Capabilities and Full Integration
The ideal CRO/CDMO will have fully integrated teams. When conducting research, the clinical trial team can constantly upload new data for the bioanalysis team. This translates to quickly adapting the drug for the clinical trial if needed, which is where the manufacturing team comes in. Can the team quickly produce the new formulation of the drug for the clinical trial? It is not ideal to outsource manufacturing during a clinical trial, and offering in-house capabilities can help get your drug to market sooner. Your partner’s capabilities should also include nanomilling to help with drug solubility. The CRO/CDMO should also be able to manufacture various dosage forms, from liquid- and powder-filled capsules to gels and creams. That way, your needs are covered no matter what your trial requires.
Dedicated and Experienced Staff
Does the CRO/CDMO offer dedicated, experienced staff for your CNS drug development cycle? This might mean a single manager guiding your organization through the entire process. Or it could mean you’re assigned Principal Investigators who are intricately involved in all aspects of the study. This helps ensure proper medical and technical procedures are conducted to the highest quality and standard.
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 and 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. 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 a CRO/CDMO for CNS drug studies at https://www.altasciences.com/
