Provide CMO services with executive ophthalmic therapeutic oversight and expertise to sponsor programs
Provide strategy and direction to ophthalmology clinical trials, processes, and procedures
Ensure quality standards are set and maintained over all ophthalmology areas of responsibilities
Provide medical oversight to the development of project documents and plans such as: IB, Protocol, DSUR
Clinical Development Plan
Protocol Design & Development
Clinical Study Report (CSR)
Represent the sponsor at Ophthalmology conferences
Development of Clinical strategic plan for First In Human, Phase I to IV, and post-marketing trials.
Study Start Up-
Develop Medical Data Review Plan and Medical Management Plans for Ophthalmology trials
Medical lead for development of Ophthalmology study eCRFs, Edit Checks, etc
Study Enrollment Phase-
Medical Review of data for Ophthalmology trials
Responding to site questions
Protocol deviations / violation management
Study Close Out Phase-
Support Database lock
Medical review of Clinical Study Report (CSR)
Medical review of Top Line Results (TLR)
PROTOCOL DESIGN & DEVELOPMENT
Provide protocol design consult to sponsors
Contribute to protocol synopsis or full protocol
Provide product development strategic planning
Early Phase protocol synopsis development strategic input includes adaptive trial design strategies for successful implementation and regulatory approval
Review the critical aspects of protocol- eligibility criteria, schedule of assessments and provide consultation on the impact on patient recruitment.
OPHTHALMIC RESEARCH TRAINING
Provide a comprehensive strategic Ophthalmology learning development program as needed.
Provide project/therapeutic training to ophthalmology sponsor / CRO project teams.
Provide full structured training and mentoring program to MDs, ODs, Pharm.Ds, DOs, and Ocular scientists interested in joining the Ocular Clinical Research industry
MEDICAL AFFAIRS CONSULTING
Provide strategy, development, management, and implementation of phase IV/post marketing clinical trials.
Lead or support global development programs and registrational trials.
Provide medical support and strategic partnering with marketing, sales, regulatory, legal and compliance.
Publication strategy development, publication writing, presentation and communication of scientific information and study data.
Lead or support product launch strategies, life-cycle management and expansion of indications for use.
SCIENTIFIC ADVISORY BOARD MANAGEMENT
Plan, organize and execute a strategic (Retina, Glaucoma, or Cornea) Expert Scientific Advisory Board meeting based on the disease area and the phase.
We provide consultation on the best advisors for any meeting, support the contract negotiation, adboard content, facilitation etc.
Top retina, glaucoma or cornea experts are qualified based on their scientific expertise, publications, translational research experience, real world expertise, Ad-board expertise, Interpersonal dynamics, communication skills and conflict of interest.
Geographic Atrophy / Dry AMD
RARE OCULAR DISORDERS
Fuch's Endothelial Dystrophy
OCULAR SURFACE DISEASES
Dry Eye Disease
DRUG CLASS &
MODES OF ADMINISTRATION
Topical Ocular drops
Stem Cell Therapy
Glaucoma Surgery / MIGS
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