The drug development cycle can be challenging. There are regulations your organization needs to follow because clinical trials are complex but crucial for completing your project. Plus, manufacturing the drug requires resources, for both the clinical trials and once your drug has gone to market. Overall, the drug development cycle leaves room for many potential obstacles. Partnering with a CRO, particularly an integrated CRO/CDMO, as early as possible in the project can help make the process smoother. For instance, there are plenty of benefits of partnering during early clinical development instead of at a later stage. Here are some reasons why partnering earlier is better.
Designing Your Clinical Study
Your organization needs a study that will safely and swiftly generate the required data to continue the drug development cycle. Partnering with an experienced CRO during early clinical development means having a team that knows all the best practices and the science. Having a proper design for the drug development cycle can make the entire process move from one stage to another much smoother. Partner early with a CRO that also offers preclinical, manufacturing, bioanalysis, and all other CRO services so data can be shared from one phase to the next. An integrated CRO will have all the teams working in tandem, making your process streamlined.
Following Regulations During Early Clinical Development
Regulatory compliance during early clinical development and beyond is essential. The laws and regulations around drug development evolve. If your organization’s staff are not well-versed in these regulations, they might not know how to adapt to ever-changing requirements. Partnering with a CRO during the early stages of your drug development cycle means you have access to a trained team from the get-go. That way, you know your organization will follow all regulations.
If you partner with an integrated CRO, their experienced team makes sure everyone is aware of the regulations as you move through phases. Furthermore, a full-service CRO won’t come with the hassle of coordinating with other CROs or between teams and sites. For example, a CRO can help you when your organization end preclinical studies and prepares to start first-in-human clinical trials. At this time, your organization must submit an investigational new drug (IND) application. Thankfully, this process is much more efficient with an experienced CRO.
Has your organization developed pharmaceutical drugs before? Did you use multiple CROs? If so, you likely know how hard it is to get CROs to communicate with each other effectively. Inefficient communication greatly hinders your project. You want clear, concise communication to progress from one stage to the next, from early clinical development to the final manufacturing process. Plus, ineffective communication channels can lead to delays. This can also contribute to potential budget problems as timelines grow. Will participants receive your drug in pill form or via injection? Without an integrated CRO, your delivery method could be unclear. Unfortunately, it would all be the result of poor communication between multiple organizations. An integrated CRO/CDMO ensures the manufacturing team already knows your goals and preferences. Consequently, every team can work in tandem toward your goals and eventual manufacturing.
Easier Access to Resources
Access to resources early in the drug development cycle can make logistics planning much simpler. A CRO that also has pharmaceutical CDMO capabilities can help with formulation and manufacturing. This helps streamline both trials and manufacturing before and after the drug is approved. Or, your organization might need access to Phase 1 clinical trial units. These facilities are especially helpful for overnight trials.
A CRO will also provide trained staff to assist and help guide your organization. They know how to market drugs for clinical trials. They have experience with strategies for recruiting and screening participants. Trained teams also know how to use the CRO’s resources safely and efficiently. Staff are trained on how to administer your drug and conduct clinical trials. Ideally, your CRO partner will have a secure, on-site room for sterile drug preparation as well.
Deciding on Recruiting Strategies Early
Finding the right population of potential participants for your clinical trial is vital. It’s something your organization needs to think about during the early stages. A CRO with recruiting experience can help your organization determine the best strategies to use. An integrated and trained recruiting team will be ready to help. They will know what kind of potential participants your study needs. The team should have access to a database of potential participants. They can then screen candidates before the study begins. Ultimately, this makes the recruiting process more efficient overall. Effective recruiting can help your organization get the data it needs to proceed with drug development.
Determining How to Market Your Clinical Trials
Even clinical trials need marketing strategies. Starting early offers you an advantage. Knowing which potential participants to market to is only half of the battle. The other half is how to market your clinical trial to them. For example, a CNS clinical trial requires different marketing than a Phase 1 clinical trial. Partnering with a CRO early can help your team better understand its overall goals. This, in turn, streamlines the recruitment process so you can get the data your organization needs.
Planning and Conducting First-In-Human Clinical Trials
Along with marketing and recruiting, preparing for first-in-human clinical trials early can be beneficial. It’s easier to avoid roadblocks if you can identify them in one of the early stages. It’s best to partner with an integrated CRO so information flows freely between teams, phases, and sites. They can plan what resources you need at each step of the way. Your team might need specific equipment or Phase 1 clinical trial units. They can also plan how to train their experts for your drug’s specific needs. Giving your team more time to plan and prepare helps make your clinical trial as efficient as possible. As a result, you can easily get the information you need, which helps you seamlessly transition through phases.
Access to Manufacturing
Finally, another benefit to partnering with a CRO with pharmaceutical CDMO services early is access to their formulation and manufacturing capabilities. This means you know you have manufacturing capabilities covered in preparation for your clinical trials. Plus, with an integrated CRO from the preclinical phase all the way through commercialization, means the manufacturing team already knows the ideal drug format. The team can start manufacturing quickly, thanks to this information.
Altasciences is a mid-sized contract research organization and drug development solution your company needs for your next drug development project. This integrated CRO with pharmaceutical CDMO and bioanalytical services offers partners over 25 years of research experience for preclinical studies and clinical trials. Altasciences has developed an innovative approach that companies in the pharmaceutical and biotechnology industries have come to rely on. Plus, partners gain access to the Altasciences team’s expertise in a wide variety of study types and therapeutic indications. This includes experience in first-in-human clinical trials and CNS clinical trials. Partners are able to utilize Altasciences’ resources, including over 580 beds, access to 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 during early clinical development at https://www.altasciences.com/