When it comes time to start a drug development cycle, it’s wise to partner with an integrated contract research organization. An integrated CRO with pharmaceutical CDMO capabilities can help take your program from the earliest phases to the market. Therefore, the right integrated CRO/CDMO can help streamline your entire process. It can assist with lead candidate selection, clinical study recruiting, regulatory submissions, and manufacturing the drug for either studies or the market. Here are seven reasons to choose your CRO/CDMO partner early.
Help with Formulation
From helping with lead candidate selection to discovering the best formulation for taking to clinical trials, a CRO can support your project from the ground up. The first steps in the drug development cycle are some of the most important. As such, these decisions guide the rest of the development cycle.
Manufacturing for Clinical Trials with a Pharmaceutical CDMO
A CRO with pharmaceutical CDMO capabilities can help manufacture your drug. Since an integrated CRO/CDMO is streamlined, your dedicated project manager is involved from the early phases of drug development. Therefore, the entire team will be prepared to start manufacturing for a Phase 1 clinical trial. Plus, if you need to make changes, the team can implement them quickly.
An integrated CRO/CDMO means information flows freely. The recruiting team is in contact with the team that will formulate the drug. This means they can better target potential participants, and the recruiting team can start earlier. This is primarily because they don’t have to wait for an information handoff from another CRO. Choose a CRO that also has a database of potential participants. This can significantly reduce the time it takes to recruit. Their trained team will also know how to market the clinical trial. This is important if you have a specialized clinical trial, such as a CNS clinical trial.
Partnering with an integrated CRO that can perform bioanalysis has major advantages. It’s faster to analyze drugs with an in-house team. This means you can make changes quickly. It can be a swift fix if the bioanalysis team finds the drug isn’t as bioavailable as needed. The pharmaceutical CDMO team can then nano mill the drug and make it more bioavailable.
Easily Modify the Drug
Because information flows quickly in an integrated CRO/CDMO, you can modify your project on short notice. Often, timelines stretch due to information handoffs. However, with an integrated CRO with pharmaceutical CDMO capabilities, teams can simply upload information to a database. All the teams see their next tasks and responsibilities, modifying the formulation or dosage. That means you can update safety protocols or tweak entire clinical studies.
Smoother Regulatory Submission
A team that has been with you since the beginning can help you navigate regulatory submissions much easier than hiring a new CRO. An experienced team will be able to navigate the constantly evolving landscape of regulations. Since they have been with you through the early phases, preparing the documentation will be a much easier and streamlined process.
Manufacturing for the Market
Finally, when it comes time to manufacture for the market, the team will be ready. They already have the experience of creating the drug for clinical trials. The CRO’s pharmaceutical CDMO services can simply ramp up production. Everything will be ready once the drug is approved. Your drug will get to market faster than trying to work with multiple CROs, each taking a small part of the process.
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 an integrated drug development cycle at https://www.altasciences.com/