The drug development cycle can present challenges for any organization. It requires tackling regulations, preclinical studies, clinical trials, manufacturing and formulation, and many potential obstacles. Each step of the process brings new variables. An integrated contract research organization or contract development and manufacturing organization is the perfect partner. A CRO/CDMO has the experience and expertise your organization needs for a smooth, successful drug development cycle. Partnering with a fully integrated CRO/CDMO from the get-go, and during early clinical development can be beneficial. Here’s how an integrated organization can support your needs throughout your next drug development project.
Regulatory Compliance During Early Clinical Development
An essential part of drug development is regulatory compliance. Laws and regulations are constantly evolving. Instead of having your own staff that keeps up with regulations, partner with an integrated CRO. The CRO should have a team well-versed in regulations, which is a major advantage for your organization. An integrated CRO with an experienced team can help you seamlessly move from one phase to the next. Furthermore, they won’t have to hand off information to other CROs. One example comes when starting first in human clinical trials. Your organization must submit an investigational new drug (IND) application. An experienced CRO can help make this process much smoother and faster.
A Focused Clinical Study Design
If your organization has never designed a clinical study, it can be challenging. How do you get the results your organization needs? An integrated CRO can help design an effective study. This can help you whether it is Phase 1 clinical trials, including complex CNS clinical trials, or bioanalysys. Therefore, your organization should partner with an integrated CRO as early as possible. Partnering in early clinical development means the CRO has plenty of time to work with other teams to devise a strategy for your study from the discovery stage, to preclinical and clinical phases, and all supporting research services.
Fewer Hand-Offs Between Siloed Teams
There are often multiple siloed CROs involved in a drug development cycle. Partnering with an integrated CRO means having a streamlined, efficient program. It means your organization can work with the same CRO from lead candidate selection and early clinical development. Then, that same CRO/CDMO can take you through first in human trials, including manufacturing. As a result, there are fewer hand-offs and fewer partners that need to be filled in on preferences and study requirements. For example, an integrated CRO/CDMO team can get a jumpstart when they know early on CNS clinical trials are required for your project. It is much easier for the CRO to account for all the required details and plan the subsequent steps of your study. A dedicated, cross-functional team can support your organization, allowing for easier scheduling and a simplified, seamless drug development experience.
Clear Channels of Communication
Separate teams across multiple CROs make for complicated communication. Ineffective communication can hinder your project from discovery to preclinical to early clinical development, including manufacturing. Plus, inefficient communication channels lead to longer development times and even potential budget problems. Will your drug be given to participants in pill form or injected? Without an integrated CRO, this could be unclear. It would all be thanks to poor communication between multiple organizations. An integrated CRO/CDMO ensures the manufacturing team already knows your goals. Consequently, every team can work in tandem toward your goals and eventual manufacturing.
Access to Resources
An integrated CRO/CDMO likely has access to many of the resources your organization needs. For example, you might need Phase 1 clinical trial units for overnight studies or driving simulators for CNS clinical trials. Typically, access to resources also includes access to trained staff. This could be recruiting teams that know how to recruit the correct participants. It also covers teams that know how to use facilities and specialized equipment. The CRO/CDMO should also have trained physicians and nurses who know how to administer the drug in a controlled environment. The CRO/CDMO should also have a secure, on-site pharmacy for sterile drug preparation. Additionally, the organization should have a list of approved vendors for sub-contracting. This gives you access to resources the CRO/CDMO is not able to provide directly.
Do you have access to the right population for your clinical trial? A CRO with recruiting experience can help your organization provide the required access. An integrated and trained recruiting team will already have access to the kind of potential participants your study needs. The team will likely have access to their own database of potential participants. They can then screen candidates before the beginning of the study. Ultimately, this makes the recruiting process more efficient. Effective recruiting can help your organization get the data it needs to proceed with drug development.
Expertise in marketing to potential participants is also critical. The CRO might need to determine the best channels for marketing when recruiting for complex studies, such as CNS clinical trials. Again, this makes it important to partner with a CRO as early as possible in early clinical development. It can help your team better understand overall goals, streamlining the recruitment process so you can move efficiently from one phase to the next.
Cross-Trained Teams to Support Your Goals During Every Step
Completely integrated, cross-trained teams can help your organization enjoy maximum transparency. You are partnered with the same CRO/CDMO as your drug moves through each phase of the project. The level of communication will be something you won’t find across multiple CROs. Cross-trained teams won’t have to wait for information to travel from one partner to another, as an integrated CRO can share this information throughout the entire organization. Everyone has access to your organization’s goals, preferences, and other vital information. This helps teams during key aspects of development and decision-making.
Conducting First In Human Clinical Trials
After recruiting, your first in human clinical trials can start. An integrated CRO/CDMO should have the necessary facilities, trained teams, doctors, nurses, and staff to help conduct these trials. Moving to Phase 1 clinical trials should be seamless. Roadblocks can be identified beforehand and are, therefore, easier to avoid. Once data is analyzed, the integrated CRO can help with other clinical trial phases, such as CNS clinical trials, and other aspects of your study.
Manufacturing and Beyond
An integrated CRO/CDMO can help you manufacture your drug for the clinical studies all the way through to commercialization. It’s best if the CRO/CDMO has been with your organization since early clinical development. This way, the manufacturing team will be able to support your scale-up needs as soon as possible. Overall, an integrated CRO/CDMO offers a seamless transition and wastes no time throughout the entire drug development cycle.
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, along with bioanalysis, formulation, and manufacturing. This full-service, integrated CRO/CDMO has developed an innovative approach to drug development and created a foundation pharmaceutical and biotechnology companies have come to rely on. Altasciences offers a fully qualified and FDA–inspected, cGMP manufacturing area capable of various dosage forms, to ensure your pharmaceutical contract manufacturing success. 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, ethnobridging, as well as bioanalytical services. 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 an integrated drug development project at https://www.altasciences.com/