Biostats, Data Management & IRT

Ora provides seamless data solutions through our strategic alliance with Statistics & Data Corporation (SDC), using industry-leading technologies such as iMedNET, Medidata, and SAS.

The Partnership Advantage

Ora and SDC share common ownership and have partnered together on hundreds of ophthalmic drug and device studies, from first-in-human through global submission projects. Our team has unparalleled experience in designing, building, analyzing, and defending ophthalmic clinical programs from start to finish.

  • Expert biostatisticians to guide your product development
  • Broad libraries of ophthalmic eCRFs and edit checks
  • Skilled project teams who understand ophthalmic studies and interact seamlessly
  • Expedited study start-up and closeout timelines
  • Flexible industry-leading technology options

Ora-SDC experts share an in-depth understanding of all ophthalmic indications and their unique regulatory environments. Leveraging our deep experience in the statistical issues that may affect each indication, our team will ensure your data is well-managed and ready for submission.

Biostatistics

Biostatisticians play a critical role in the planning, preparation, and execution of any clinical program. From clinical trial design to representation at regulatory meetings, the Ora team is here to support you every step of the way, providing the highest quality statistical deliverables. Our expert biostatistics team consistently delivers top-line analysis within 5 business days after database lock and final results within 3 weeks of database lock, including full submission-ready Clinical Data Interchange Standards Consortium (CDISC) deliverables.

Data Management/Electronic Data Capture (EDC)

When it comes to clinical trial success, data integrity is key. Our clinical data management experts are committed to providing the highest data quality, integrity, and security on your clinical trial.

Our data management team fully understands and complies with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards. Leveraging industry-leading EDC technologies such as iMedNet eClinical and Medidata Rave, Ora provides a seamless flow of data and communication, and a wealth of ophthalmic clinical trial data management experience.

Our Data Management/EDC Services

  • Optimal technology recommendation based on clinical trial needs
  • 24/7 EDC helpdesk
  • eCRF design and development
  • eCRF completion guidelines development
  • Patient reported outcome (PRO) design and development for patient diaries / questionnaires with ePRO, paper, and hybrid options available
  • Data management plan development
  • Data validation manual development
  • EDC system training for system end users
  • Clinical database development, validation, and user acceptance testing (UAT)
  • Edit check programming, validation, and testing
  • Extensive library of status reports, and development of custom status reports available to EDC system end users in real-time throughout studies
  • Adverse event, 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 quality control (QC) review
  • SAE reconciliation between safety and clinical databases
  • Database lock and study archival

Interactive Response Technology (IRT)

Interactive Response Technology automates patient randomization and inventory management to help even the most complex clinical trials run smoothly and efficiently. Ora’s IRT experts will help you select the best technology solution for your clinical trial, then work as an integrated part of your clinical trial team throughout the entire study.

Our IRT Services

  • Optimal technology recommendation based on clinical trial needs
  • Industry-leading IRT solutions via iMedNet eClinical, Medidata Rave (RTSM/Balance), Endpoint, and more
  • 24/7 IRT helpdesk
  • User requirements specifications development
  • IRT database development, validation, and testing
  • User acceptance testing (UAT)
  • Custom inventory status development
  • Automated patient randomization
  • Triggered and predictive automated inventory re-supply
  • Emergency unmasking
  • Drug expiration management