When your organization develops a drug that affects the central nervous system, early clinical development can be complex, and requires teams with extensive clinical research expertise. As a result, many organizations partner with a contract research organization that has the necessary experience to conduct their CNS trials during the early stages of the drug development process. Here are a few factors to keep in mind when your organization is searching for the right CRO partner for your CNS trials.
Experience Handling Regulations
Regulations for CNS drugs can be intricately detailed. You want to find a CRO with experience in adaptive trial designs often associated with CNS clinical trials and therapies, as well as bioanalysis needed for on-time regulatory submissions. The CRO team should also have experience working with Institutional Review Boards. Familiarity with IRBs means your protocol will be submission-ready while minimizing the potential for making amendments later, thus shortening your study’s start-up time.
Specialized Recruiting Strategies
Your chosen CRO should have experience recruiting potential participants for CNS studies. These can be different from typical first in human clinical trials, which may have broader needs. Experience recruiting for both types of studies is ideal. Having an in-house, full-time recruitment team means the CRO does not need to relay your requirements and preferences to outside organizations. Instead, the CRO can start creating efficient recruitment strategies through the most effective channels to meet any of your target milestones. Plus, access to a curated database of potential participants can help drastically reduce recruiting time.
Sterile Drug Preparation Facilities
Find a CRO with clean rooms for sterile drug preparation and staff experience in extemporaneous and intravenous preparation, including biologics. You will need staff with experience in preparing and dosing studies, particularly in the method your specific drug will be administered. This could be oral, sublingual, intranasal, or parenteral routes. Make sure the pharmacies are secured, such as with electronic fobs, facial recognition, or video monitoring.
A Team of Dedicated Research Physicians and Analysts
Having a team of dedicated research physicians that are deeply involved in all aspects of your CNS clinical trials can help ensure the proper technical and medical procedures are completed. Keeping lines of communication open is vital. A full-service CRO can easily provide the physicians with the information they need from previous phases, helping information flow seamlessly. The physicians should be familiar with how CNS clinical trials differ from typical clinical trials.
Driving Simulations and Cognitive Testing
Finally, having qualified resources available to do additional tests, such as cognitive tests or driving simulations studies is a great benefit. The driving simulation, for example, can help provide accurate information on driving performance data that compares to over-the-road testing but in far less time. It also costs less and doesn’t risk any potential property damage or injuries to the participant. These types of studies can highlight the effects of age, trauma, drowsiness, neurologic disease, CSN stimulants, and CNS depressants.
About Altasciences
As a mid-sized contract research organization and drug development solution, Altasciences offers partners more than 25 years of research experience for preclinical studies and clinical trials. As an integrated CRO, CDMO pharma services are just one of many that Altasciences offers, with an innovative approach both biotechnology and pharmaceutical companies rely on. Clients also gain the Altasciences teams’ expertise in a wide variety of study types and therapeutic indications, including vast experience in first-in-human clinical trials, CNS clinical trials, and ethnobridging. Altasciences provides partners with access to dedicated Phase 1 clinical trial units across North America, both in the USA and Canada. Partners can utilize Altasciences’ resources, including access to over 580 beds, an experienced, highly trained staff, and a recruiting database of more than 400,000 potential participants. Partner with this trusted CRO/CDMO for all your early clinical development needs.
Partner with Altasciences for your early clinical development and CNS clinical trials at https://www.altasciences.com/
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