Whether you are starting early clinical development or considering Phase 1 clinical trials, you will likely want to partner with a contract research organization or contract development and manufacturing organization. Here are some key factors to look for, whether you are outsourcing a specific aspect of your ophthalmic drug development program or partnering with an integrated CRO/DCMO for the entire program.
Preclinical Safety Testing
First and most importantly, search for a CRO/CDMO with plenty of experience. It’s best to find an organization that has never had a study rejected due to design, conduct, or data integrity. If the CRO/CDMO has had a study rejected, find out why. The organization should have a broad range of solutions across dosing routes, as well as the ability to use special techniques if needed. Specialized equipment for ophthalmic studies is definitely an advantage.
Clinical Research Services and Resources
If you are creating an ophthalmic drug and partnering with a CRO, ensure they have an in-house ophthalmologist. The CRO will preferably have facilities with plenty of beds for clinical tests and both inpatient and outpatient capabilities. If they have conducted successful ophthalmic drug trials in these facilities in the past, you can confidently partner with the CRO for your development. Another bonus is access to a database with potential participants for clinical trials to help you find the right participants efficiently.
Formulation, Manufacturing, and Analytical Services
A good CRO will prioritize seamless transitions between the preclinical and clinical phases, from lead candidate selection to clinical proof of concept, including formulations and manufacturing. A pharmaceutical CDMO should be able to manufacture both potent compounds and controlled substances, depending on your drug’s needs. It will ideally have Class C manufacturing suites to develop both clinical and commercial batches. It should also be capable of flexible filling options to meet your needs, including vials, droppers, or even custom containers.
Bioanalytical Services
When your organization is choosing a CRO for your next ophthalmic drug development project, you want to make sure it has strong, in-house ocular bioanalytical services and expertise. The bioanalytical scientists should be able to work with the study directors to ensure all samples are handled appropriately. If possible, it should be able to achieve low limits of quantitation for system exposure. In other words, it should be prepared with assay platforms and other equipment that provide the ultra-low sensitivity needed for serum or plasma TK/PK samples used in ocular drug development. Another major advantage for a CRO is expertise working with rare and limited matrices. In the case of ophthalmic drugs, this usually means tears.
Regulatory Approval Expertise
Finally, the team should be able to provide expertise on regulatory approval. They should be up to date on the constantly evolving regulatory requirements, ensuring your program can stay on track and meet deadlines. From nonclinical and clinical regulatory strategy to CTA preparation, submission, and maintenance or toxicology consulting and strategic advice, the more experience in dealing with regulations, the better for your organization.
About Altasciences
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 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 for ophthalmic drug development at https://www.altasciences.com/
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