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

Dr. Sandeep Walia, CBCC SME - USA

  • Dr. Walia is associated with Southwest Eyecare and Laser Medical Associates in Bakersfield, California, USA. Dr. Walia earned his Bachlor’s degree in marketing from the University of Texas, Austin and received his M.B.A from Chadron State. He earned his medical degree from Texas Tech University. Dr. Walia completed his ophthalmology residency at Emory Eye Center and he has authored over a dozen publications. Further, he underwent extensive cataract surgery training at Harvard Medical School. He is a Comprehensive Ophthalmologist, specializing in eyelid surgery, LASIK, glaucoma, MIGS, cataract surgery, intravitreal injections, and medical management of posterior segment disease like AMD and diabetic retinopathy.

Prof. Dr. Amar Agarwal, CBCC SME - INDIA

  • Prof. Amar Agarwal is the Chairman of the Scientific Committee: Intraocular Implant & Refractive Society, India and the Chairman of Dr. Agarwal’s Eye Hospital Ltd., Chennai. He is a pioneer in Phakonit surgeries and has rolled out quite a few innovations from the surgical tables of his hospital. Be it a glued IOL on senior patients or anterior segment transplantation in a four-month old child. He has won many awards and accolades for his revolutionary innovations in ophthalmology, most significant being the BARRAQUER and the KELMAN awards. In addition to this, he is also a voracious writer and has authored over 50 books that have been published in several languages.

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 experience on ophthalmology clinical trials

  • Irrespective of your focus area and requirement of 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:




    Keratoconjunctivitis Sicca


    Refractive Errors


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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