In 2017, the FDA declared that driving simulation studies are required for all drugs that may affect cognition. During early clinical development, your organization must determine whether a driving simulation test is needed for regulatory approval. If so, it’s a good idea to partner with a contract research organization that has the experience and resources necessary to carry out the testing. Here are four reasons you should consider partnering with a CRO to conduct driving simulation tests.
Recruiting Database Speeds Up Recruiting
An experienced CRO will have access to an extensive database of potential participants for your study, from healthy normal volunteers to patients and special populations. These potential participants may have the necessary qualifications for your study or will be easier to screen than if you simply marketed the study to the general population. The CRO can perform the screening process, helping the study get started as early as possible. A recruiting database is also essential when your organization is doing specialized testing, such as CNS clinical trials. These trials have more specific requirements for potential participants than a typical clinical trial.
CROs Have Resources
Partnering with a CRO also means gaining access to its resources. This can include driving simulators and experienced teams. The CRO will have the equipment needed to conduct the driving tests. Suppose you are choosing an integrated CRO and performing other tests besides driving simulations, such as first-in-human clinical trials. In that case, this also means resources such as Phase 1 clinical trial units. The CRO should be able to provide everything you need to help your drug to progress through the early phases of drug development.
CROs Have the Experience You Need
There’s another type of resource you will have access to when you partner with a CRO: trained employees. These employees have the experience necessary to carry out the driving simulation. They know how to work the equipment and how to guide participants through the test. Other employees know how to collect and present data. When you use a CRO for more than just the tests, the employees can also interpret the results and help with your drug development cycle.
It’s Easier and Safer Than Typical Driving Tests
A typical driving test might be done on a closed course in a real car. Among other considerations, you will need space to perform the test, the car itself, gas, safety cones, and more. Plus, you will need someone in the passenger seat to observe the participant driving. Partnering with a CRO that has access to driving simulators means you won’t need any other resources. It’s also safer for the participant as there is no crash risk. Instead, it uses a simulated car with computer monitors to mimic driving on the road. A CRO that specializes in driving studies will also be able to offer oversight by fully-certified, in-house driving simulation study specialists to help ensure you are recording proper results.
Drug development can be a complex process. Altasciences, a mid-sized contract research organization, can help make it more streamlined. This integrated CRO with pharmaceutical CDMO capabilities offers partners more than 25 years of research experience performing preclinical studies and clinical trials. Pharmaceutical and biotechnology companies have come to rely on the innovative, integrated approach that Altasciences uses. Partners gain the team’s expertise in studies for a wide variety of therapeutic indications. Altasciences also gives partners access to the CRO’s various resources, including over 580 beds, experienced and highly trained staff, and a recruiting database with more than 400,000 potential participants. When you need a partner for all your early clinical development needs, trust Altasciences.
Partner with Altasciences for driving simulations and a whole lot more at https://www.altasciences.com/
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