Logo - Ocular Services On Demand

Non - Clinical Development

OSOD ocular toxicology and technical experts understand the species-related and logistical factors critical to acquiring high quality ophthalmic data for your IND-enabling program. We have robust experience working with all relevant lab species and can provide you with an optimal planning of your ophthalmic safety and toxicology study designs and we can execute these intricate methods of administration of drug or surgical implantation of ocular devices meeting all regulatory standards for GLP in support of your FDA submission

 

Clinical and regulatory guidance

 

  • Expert high-level guidance by seasoned clinicians on initial clinical study designs to inform IND-enabling activities

  • Strategic Consultative support to design IND-enabling safety and toxicology studies for pre-IND and IND meetings with the regularity authorities

  • Coaching for Pre-IND meetings with regulatory authorities

  • Support for interpreting and responding to regulatory authority questions and/or comments

 

GLP toxicology program design and execution

 

  • Study Monitoring and project management support for your in-life IND-enabling studies

  • All routes of administration for ophthalmic drug in all species

  • Full surgical capabilities for implantation of ocular devices

  • State of the art imaging and diagnostic equipment for data collection

 

Data analysis and interpretation

 

  • Expert data analysis and interpretation by board-certified MD and DVM ophthalmologists

  • Data capture and access in a US and European regulatory platform

  • Clinical and regulatory guidance

 

 

Eye Image diagram dose administration

 

For more information about our team:

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