5 Features to Look for in a CRO/CDMO for Your Ophthalmic Drug Development Program
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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