SERVICES
CLINICAL DEVELOPMENT
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Provide CMO services with executive ophthalmic therapeutic oversight and expertise to sponsor programs
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Provide strategy and direction to ophthalmology clinical trials, processes, and procedures
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Ensure quality standards are set and maintained over all ophthalmology areas of responsibilities
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Provide medical oversight to the development of project documents and plans such as: IB, Protocol, DSUR
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Clinical Development Plan
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Protocol Design & Development
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Clinical Study Report (CSR)
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Represent the sponsor at Ophthalmology conferences
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Development of Clinical strategic plan for First In Human, Phase I to IV, and post-marketing trials.
MEDICAL MONITORING
Study Start Up-
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Develop Medical Data Review Plan and Medical Management Plans for Ophthalmology trials
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Medical lead for development of Ophthalmology study eCRFs, Edit Checks, etc
Study Enrollment Phase-
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Eligibility Review
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Medical Review of data for Ophthalmology trials
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Safety assessment
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Responding to site questions
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Protocol deviations / violation management
Study Close Out Phase-
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Support Database lock
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Medical review of Clinical Study Report (CSR)
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Medical review of Top Line Results (TLR)
PROTOCOL DESIGN & DEVELOPMENT
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Provide protocol design consult to sponsors
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Contribute to protocol synopsis or full protocol
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Provide product development strategic planning
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Early Phase protocol synopsis development strategic input includes adaptive trial design strategies for successful implementation and regulatory approval
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Review the critical aspects of protocol- eligibility criteria, schedule of assessments and provide consultation on the impact on patient recruitment.
OPHTHALMIC RESEARCH TRAINING
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Provide a comprehensive strategic Ophthalmology learning development program as needed.
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Provide project/therapeutic training to ophthalmology sponsor / CRO project teams.
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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
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Provide strategy, development, management, and implementation of phase IV/post marketing clinical trials.
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Lead or support global development programs and registrational trials.
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Provide medical support and strategic partnering with marketing, sales, regulatory, legal and compliance.
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Publication strategy development, publication writing, presentation and communication of scientific information and study data.
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KOL management
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Lead or support product launch strategies, life-cycle management and expansion of indications for use.
SCIENTIFIC ADVISORY BOARD MANAGEMENT
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Plan, organize and execute a strategic (Retina, Glaucoma, or Cornea) Expert Scientific Advisory Board meeting based on the disease area and the phase.
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We provide consultation on the best advisors for any meeting, support the contract negotiation, adboard content, facilitation etc.
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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.
RETINA
Neovascular AMD
Geographic Atrophy / Dry AMD
DME
CRVO
BRVO
CME
CATARACT SURGERY
Antibiotics
Anti-inflammatories
Steroids
Devices
RARE OCULAR DISORDERS
Retina
Retinitis Pigmentosa
LCA-10
CRD
Cornea
Fuch's Endothelial Dystrophy
OCULAR SURFACE DISEASES
Dry Eye Disease
MGD
Conjunctivitis
Chalazion
DRUG CLASS &
MODES OF ADMINISTRATION
Intravitreal Injections
Sub-retinal injection
Gene Therapy
Biosimilars
Anti-VEGF, Anti-PDGF
Complement Inhibitors
Steroids
Topical Ocular drops
Oral
Stem Cell Therapy
CRISPR
GLAUCOMA
Ocular Hypertension
POAG
Glaucoma Surgery / MIGS
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