Ophthalmology

CBCC’s capabilities for quality and timely execution of ophthalmology clinical trials


  • Team of experienced medical writers, medical monitors and subject matter experts (SMEs) help design robust clinical trial protocols and ensure regulatory compliance, enhanced patient enrollment & retention, and timely completion of the trial with high quality
  • Sound understanding and proven regulatory track record with the US, India and other regulatory agencies to help obtain the required permissions
  • Trained and experienced study team assessing feasibility, site qualifications and onboarding of right sites to complete the study with pre-defined timelines to ensure timely CSR delivery and dossier submission to regulatory agency
  • Skilled study team for site management, tracking patient enrollment and site monitoring
  • Robust initial and periodic training of the study team on critical aspects of the study, study procedures, assessments, and anticipated safety aspects
  • Expert data management, biostatistics and report writing team for timely delivery of regulatory-compliant study reports

CBCC’s experience on ophthalmology clinical trials


  • Irrespective of your focus area and requirement of the most common or rare ophthalmic condition, our team can support end-to-end clinical trial execution of ophthalmic preparations
  • Few indications, in which our team has supported leading pharmaceutical and biotech companies for ophthalmology drug development, are:
    • Glaucoma

      Vitrectomy

      Cataract

      Keratoconjunctivitis Sicca

      Astigmatism

      Refractive Errors

      Conjunctivitis

Site Network


  • We follow stringent criteria in selecting study sites to generate high-quality data within competitive timelines
  • We have >100 ophthalmology clinical trial sites in our database, and the site investigators and staff are exceptionally trained in current regulatory requirements with experience in multiple indications
  • We also have premium site network having prior experience in successful regulatory inspections
  • We have a network of >60 sites in India and >40 sites in the US. In addition to this, we can support patient enrollment in China, Australia, Africa and European countries through partners

CBCC’s value addition to your ophthalmic drug and device development


  • With our scientific, medical and operational expertise, we are well placed to support all your clinical development programs for both, simple and complex ophthalmic drugs and devices.
  • We can support you to:
    • Design scientifically sound, regulatory compliant and medically corroborating clinical trial programs for NCEs, 505b2s and ANDA submissions

      Manage projects and facilitate all regulatory activities including USFDA communications

      Select the right sites with high patient pool to expedite patient enrollment

      Manage multi-country patient enrollment from site selection to close-out

      Generate high-quality data at sites through optimum monitoring plans

      Ensure continuous support during post-study regulatory inspections

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