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Data quality and integrity
ELS 2

 

Overview

ELS provides the unique combination of local and global support to the client for their projects. The key diffenrentiators include:
  •  More than 250 man years of experience in managing global and domestic clinical research projects
  • Medical expertise to support the global client on a 24/7 basis
  • Site centric model to support in the day-to-day activities
  • Highly experienced and trained Clinical Research Coordinators (CRC) to support the site team and generate high quality data
  • CRC support for audio-visual consenting procedures
  • Regulatory support for global and domestic clients
  • Coordinate with EC for timely submission, follow up and approval
  • Project and site specific recruitment activities for faster enrollment
  • Timely submission of safety reports to the EC and the regulatory
  • Experienced in FDA and EMA inspections

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Per of global
  • Global ophthalmology trial for uveitis
  • India started 12 months after other global sites
  • Currently India has the maximal contribution towards the global patient pool
  • The ratio of sites in India vs RoW was 1:3
  • Project and site specific referral and recruitment strategies were utilized
enr total
  •  Global ophthalmology trial for uveitis
  •  Site identification done by ELS
  •  Average enrollment per site was the highest from  the Indian sites
  •  This was largely contributed by the presence of  trained CRC at site
Open Queries
  •  Global ophthalmology trial for uveitis
  •  With maximal enrolment globally ELS operations  team managed to keep the  open queries at a  minimum
  •  Query resolution turn-around time was within 48  hours
  •  Dedicated ELS resources at each site resolve  queries within timeline
Visits Completed
  •  Total number of screening, randomization, follow up  and unscheduled visits  completed by ELS team till  date
  •  This includes trials for all therapeutic areas
  •  All protocol defined activities were completed on time during these visits
  •  96% of these visits were on schedule or within the window period