Data Management

For data management services, Ora partners with our sister company, Statistics & Data Corporation (SDC). Since 2005, Ora and SDC have worked together on more than 100 phase I-IV studies, giving SDC unparalleled experience in designing, building, and analyzing ophthalmic trials.

Extensive libraries of standard ophthalmic eCRFs & edit checks
Experienced, driven project teams require minimal oversight from Sponsors
Seamless interaction between SDC and Clinical Operations teams at Ora
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When it comes to clinical trial success, data integrity is key. With a world class technological infrastructure and a team of top managers and directors, SDC is committed to providing the highest data quality, integrity, and security.

Through frequent coordination with clinical operations, SDC provides a seamless flow of data and a constant level of communication to ensure that projects meet deadlines and milestones, and keep clinical trials on track for timely conclusion. Our data management experts also fully understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.

Whether the trial is a large international study or a single-center proof of concept trial, SDC understands how crucial it is to get the project running efficiently. Clinical data management plays a key role from study startup through closeout and our team works seamlessly with clinical operations to meet all of the critical milestones of a sponsor’s project. SDC consistently meets or exceeds sponsor expectations in regard to both timelines and quality. Key advantages to partnering with Ora/SDC for data management services include the following:

  • Extensive libraries of standard ophthalmic eCRFs & edit checks
  • Experienced, driven project teams require minimal oversight from Sponsors
  • Seamless interaction between SDC and Clinical Operations teams at Ora
  • SDC has provided clients with over 98% on time delivery of key milestones since 2011
  • Expedited study startup & closeout timelines
  • Since 2009, Ora Monitors, Investigators, and site staff have been trained and are very experienced utilizing SDC’s database systems, including Oracle RDC and iMedNet EDC
  • Discrepancy management tool developed by SDC/Ora
    • Discrepancy trend metrics are fed upstream to project management, monitors, and sites to improve data entry quality over the course of a study
    • This same tool led to SDC/Ora being selected as a finalist for the 2011 SCDM Data Driven Innovation Award
  • SDC’s data management leadership team brings extensive ophthalmic experience
    • Dale W. Usner, PhD, President - approximately 20 years leading and executing clinical trial research, including 10+ years in ophthalmic pharmaceuticals and devices
    • Teri Hicks, Director of Data Management - 20+ years of industry experience in clinical and health information with therapeutic expertise in ophthalmology, medical devices, cardiology, endocrinology, infectious disease, and nephrology
  • SDC’s Data Management Services Include:
  • Data Management Trial Master File Set-Up and Maintenance
  • eCRF/CRF Design and Development
  • CRF and Diary Completion Instructions
  • Subject Diary Design and Development
  • Data Management Plan Development
  • Data Validation Manual Development
  • Edit Check Programming, Validation and Testing
  • Clinical Database Creation, Validation and Testing
  • EDC System Training for Sites & Monitors
  • Adverse Event and Concomitant Medication, and Medical History Coding
  • Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
  • Continual Data Cleaning and Query Reconciliation throughout Study
  • Independent QC Review
  • Development of Custom Status Reports upon Request
  • SAE Reconciliation between Safety and Clinical Databases
  • 24/7 EDC Helpdesk
  • Development of Custom Status Reports to Excel