When your organization begins drug development, you want every advantage for success. However, early clinical development can be a challenge for inexperienced organizations. Teaming up with a contract research organization can help streamline the drug development process. With trained teams, a wealth of experience, and resources, you might find that your drug development becomes more efficient. Here are some of the ways a CRO can help your organization.
Designing Clinical Studies at the Beginning of the Program
Designing a clinical study for an inexperienced organization can sometimes be challenging. It may not be clear what design is optimal to get the results your organization needs. The right CRO can help. With their guidance, you can design an optimal clinical study. Complex trials such as CNS clinical trials can require specific endpoints. It is important to partner with a CRO that has the scientific and operational expertise to help you obtain the data you need. Therefore, the earlier you partner with a CRO, the more likely you they can help create an optimal design for your organization’s clinical studies.
Ensuring Regulatory Compliance During Early Clinical Development
Regulatory compliance is essential for a drug development program. Laws and regulations are always evolving. Therefore, it can be challenging to keep up with regulatory requirements. That is why a team well-versed in regulations across the globe can be a major asset. You will be able to move from one phase of drug development to the next more efficiently and understand what is required depending on which country you plan to get regulatory approval. For instance, if your organization is starting first in human clinical trials, you need to submit an investigational new drug (IND) application to the US FDA or a CTA in Europe. A CRO can assist in the regulatory strategy and actual application, making the process smoother and faster.
Recruiting for Clinical Trials in Early Phase Trials
Recruiting for clinical trials means understanding inclusion and exclusion criteria and determining which populations your organization plans to target. Then you can advertise to potential participants and screen each candidate before the beginning of the study. A CRO with a team experienced in recruiting can ensure your organization meets its clinical milestones. That way, you can move efficiently from one phase to the next. A CRO might also have access to a database of potential participants. That can help make your recruiting process faster and easier. Determining the best channels for marketing when recruiting for CNS clinical trials is essential. So, partner with a CRO as early as possible in early clinical development. It can help your team better understand what you need during the studies, streamlining the recruitment process.
Offering Necessary Resources
Your CRO partner should also have access to the necessary resources you need for early clinical development and beyond. Whether you need scientific guidance, operational expertise, recruitment or facilities to conduct overnight studies, the right CRO can help. A CRO focused on early phase clinical trials can ensure you meet critical milestones safely and effectively.
Conducting First In Human Clinical Trials
Finally, a CRO can conduct first in human clinical trials for your organization. The CRO can conduct clinical trials using its facilities, equipment, trained teams, doctors, nurses, and other operational trained staff. An experienced CRO will know the potential roadblocks and how to avoid them. After first in human clinical trials, the right CRO will be able to guide your organization through other phases of early clinical development.
Altasciences is a mid-sized drug development solution company offering more than 25 years of research experience for your preclinical studies and clinical trials. As an integrated CRO/CDMO, Altasciences’ innovative approach is one biotechnology and pharmaceutical companies rely on. Altasciences guides clients through the drug development process with custom program roadmaps, from lead candidate selection to early clinical development to manufacturing. Altasciences also has key experience in CNS clinical trials, first-in-human clinical trials, and Ethnobridging. The CRO/CDMO provides partners access to dedicated Phase 1 clinical trial units across both the USA and Canada. Resources include over 580 beds, a recruiting database of over 400,000 potential participants, and an experienced, highly trained staff. If your organization needs dedicated and integrated CRO/CDMO services, Altasciences is the perfect choice.
Partner with Altasciences for early clinical development solutions at https://www.altasciences.com/