Ophthalmology

THERAPEUTIC EXPERTISE

Ophthalmology

Our capabilities for quality and timely execution of Ophthalmology clinical trials

  • Medical adviser/KOL with > 3 decades of experience in NCE clinical trials of products approved in the past 20 years
  • Access to >70 sites across USA and India with an excellent regulatory track record
  • Management of complex drug supply to multiple sites
  • Effective site distribution and naïve site development in competitive studies to avoid recruitment challenges
  • Access to wet animal lab to conduct studies on animal eyes before initiating early phase clinical trials

EXPERIENCE

Therapeutic Areas

  • Cataract
  • Glaucoma
  • Dry eye disease
  • AMD
  • Astigmatism
  • Vitrectomy

Exclusive site network in the US and India

4 device studies and 10 clinical endpoint studies across 70+ sites in the US and India

Three 505(b)(2) programs

Sample size ranging from 20 to 500 patients

Patient drop-out rate <10%

Established regulatory compliant processes and experienced in managing blinding IPs which is one of the most complex aspects of Ophthalmology clinical trials

SCIENTIFIC ADVISORY BOARD

Dr Jason BacharachFounder - North Bay Eye Associates

Dr Sam GargVice Chair & Medical Director - The Gavin Herbert Eye Institute

Dr Mitch JacksonFounder/Medical Director - Jacksoneye

Dr Rishi SinghStaff surgeon - The Cole Eye Institute

Dr Amar AgrawalChairman and MD - Dr Agarwal’s Eye Hospital and Eye Research Centre

Dr Sandeep WaliaOphthalmologist - Southwest Eyecare and Laser Medical Associates

Dr Ehsan Sadri

SCIENTIFIC ADVISORY BOARD
REQUEST FOR PORPOSAL