Biometrics and Technology Solutions

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

Since 2005, Ora has leveraged our premier partnership with Statistics & Data Corporation (SDC) to deliver unsurpassed biometric services and technology solutions. 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.

The SDC Difference

Effective Technology Solutions

SDC DataHub, an AI enabled data lake that is the next generation backbone for a Clinical drug development ecosystem.

SDC Insights provides our clients visibility into what is happening in their trials independent of the system, all in one place.

SDC Capture provides an efficient, patient centric and easy to deploy ePRO/eCOA solution to meet your cost and timelines needs.

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Scalable Service Offerings

Core biometric services

Biostatistics
Data management
Interactive response technology
Supporting technologies (EDC, IRT, eCOA, etc)

Early stage consulting through full CRO services

Partner solutions

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Focused Service Area Specialists

Therapeutic area experts
Dedicated client based project teams
Direct access to SMEs

Industry leading delivery of LPLV-DBL-topline TLFs

Customized / rapid study startup
Efficient project Timelines
98% on time delivery

Proven Success and Experience

Regulatory submission specialists

30+ product approvals supported
Pre-IND through NDA approval
ISS/ISEs

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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

SDC’s relationship-based service model begins with strategic level consultants partnering with clients to optimize their clinical development program. This approach, paired with expert data services (biostatistics, data management/EDC, and IRT/IWRS) and network of alliance partnerships, allows SDC to provide flexible service solutions to advance clients programs from first-in-human through post-approval trials. SDC deploys a variety of industry leading software solutions to meet study needs such as Safety, IRT, eSource, eConsent, EDC and ePro, all plugged into SDC DataHub enabling superior analytics through SDC Insights, SDC’s system agnostic reporting backbone. With a proven track record, SDC will help to ensure the successful execution of your clinical program. SDC offers clients leading technology options licensed via trusted and proven partnerships with the industry’s best providers. SDC evaluates each project based on study design, therapeutic area, location/language requirements, etc, and makes recommendations to clients regarding the optimal technology solution for their studies. SDC has completed a robust qualification process for each of our preferred technology partners. This process includes thorough qualification auditing as well as SDC’s independent fit- for- use validation for each of these systems.

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