Biostatistics, Data Management and IRT

For data services, Ora provides seamless solutions to our clients through our strategic alliance with Statistics & Data Corporation (SDC).  Ora and SDC share common ownership and have partnered together on hundreds of ophthalmic drug and device studies, ranging 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.

The Ora-SDC team of experts shares an in-depth understanding of all ophthalmic indications, as well as their unique regulatory environments. Leveraging our experience and knowledge of historical analyses of ophthalmic clinical programs and the distinct statistical issues that affect each respective indication, our data services team will ensure your data are well-managed and ready for regulatory submission.

The Ora-SDC partnership advantage provides you with:

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

Biostatistics

The biostatistician plays a key role in the planning, preparation, and execution of a clinical program. From clinical trial design to representation at regulatory meetings, our team is here to support you every step of the way.  We are dedicated to providing the highest quality statistical deliverables. We consistently deliver top-line results within 5 business days after database lock and full results delivered within 3 weeks of database lock, including full submission-ready CDISC deliverables.
SDC is a CDISC Registered Solutions Provider and maintains specialized expertise in providing CDISC-compliant analysis packages and legacy data conversion for ophthalmic clinical trials.

Biostatistics Services Include:

  • Adaptive trial design & statistical modeling
  • Protocol input and development
  • Power and sample size calculations
  • Client representation at regulatory agency meetings
  • Randomization schedule preparation
  • Analysis methodology development and evaluation
  • Statistical analysis plan development
  • SAS programming and validation
  • Independent QC of analysis and statistical programming
  • Interim analysis planning
  • Data monitoring committee (DMC) and data safety monitoring board (DSMB) participation
  • Pharmacokinetic (PK) analysis
  • CDISC deliverables (SDTM, ADaM, Define.xml)
  • CDISC conversion of legacy data
  • MetaAnalysis/Post hoc analysis
  • ISS/ISE (Integrated Summary of Safety/Integrated Summary of Efficacy)
  • Statistical reporting
  • Review and support for publications

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.

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, we provide a seamless flow of data and communication, and a wealth of ophthalmic clinical trial data management experience.

Data Management/EDC Services Include:

  • 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 subject 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 report & 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 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 make even the most complex clinical trials run smoothly and efficiently. Our expert IRT team will help you select the best technology solution for your clinical trial and will work as an integrated part of your clinical trial team throughout the entire study.

IRT Services Include:

  • Optimal technology recommendation based on clinical trial needs
    • Fully integrated EDC/IRT solutions via iMedNet eClinical
    • Other industry leading IRT technology solutions via medidata balance, endpoint, and other SDC/Ora approved
  • Technologies
  • 24/7 IRT helpdesk
  • User requirements specifications development
  • IRT database development, validation and testing
  • User acceptance testing
  • Custom inventory status development
  • Automated patient randomization
  • Triggered and predictive automated inventory resupply
  • Emergency unmasking
  • IRT project management

For more information about our data services or to schedule an EDC or IRT system demonstration, please contact us

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