Establishing product safety and efficacy in humans is a critical part of any ophthalmic development program – and companies need to work with a clinical research provider who is experienced, has the scale to deliver on time and within budget, and has a track record of successful trials and product approvals. At Oculos, we have it all – industry experience, international recognition and a track record of approvals. And our experience, not only as a service provider – but also as a Sponsor, provides us a unique window into what it takes to deliver a clinical research program with excellence.
As a full-service ophthalmic clinical research partner, we offer the following services in support of our clients’ clinical programs:
- Clinical trial design and development
- Protocol development
- Site selection
- Investigator meeting planning, production and execution
- Investigational material packaging, labeling and distribution logistics (including IRT)
- Electronic data management
- Electronic trial master file (eTMF)
- Site monitoring (on-site and central)
- Biostatistics
- Clinical study reports
- Preparation of clinical submission documents
- Access to nationally recognized medical advisory board and Key Opinion Leaders (KOLs)