DATA & BIOSTATISTICS

Our data solutions deliver precision and performance.

Ora’s Biometrics Team is the industry leader in designing, executing, and analyzing ophthalmic clinical trials with our relationship-based service model and strategic-level consultants.

We leverage preferred technology platforms iMednet and Medidata Rave as well as other leading technologies to add value and increase productivity of clinical trials.

Our team is also leading initiatives to develop next generation AI/ML based tools for analytics, data visualizations and efficient data processing. This top-tier data services model coupled with leading technologies round out our service offerings as the world’s leader in ophthalmic clinical trials.

Ora’s transformation to meet the needs of decentralized clinical trials of the future starts with the patient and comprises a comprehensive end-to-end technology solution that integrates paperless trial capabilities with consolidated reporting across platforms.

EDC, IRT, eCOA/ePRO, eSource, eConsent, eReg, and Safety are all deployed on industry leading software with SDC Insights as a software agnostic reporting backbone.

Our newest technology release is based on our specially designed warehouse that allows us to not only centralize data across platforms but also deploy data out from one system to another to reduce redundancy in data entry. With single sources of truth, we ensure that the information generation comes from the correct source as reports are only as good as the data behind them.

Biostatistics

Ora Biometrics specializes in providing expert biostatistics services tailored to all phases of clinical development. Our team of top-tier biostatisticians are industry leaders in applying advanced statistical concepts to meticulously design and execute efficient clinical trials. From the initial stages of protocol design to the final stages of regulatory submission and defense, our dedicated biostatistics team works alongside you every step of the way. We’re committed to helping you interpret your data with precision and clarity, empowering you to make informed decisions that drive the success of your clinical program.

Our Biostatistics Services Include:

Clinical Trial Design
Protocol Development
Sample Size Calculations
Representation at Regulatory Agency Meetings
Statistical Regulatory Consulting
Randomization Schedule Preparation
Statistical Analysis Plan (SAP) Development
SAS Programming and Independent Validation of Tables, Listings, and Figures
Interim Analysis Planning
Topline Analysis Package

Final Analysis Package
DMC Statistics Services
PK/PD Analysis
Rescue Study Services
CDISC Deliverables (SDTM, ADaM, Define)
CDISC Conversion of Legacy Data
Integrated Summaries of Safety and Efficacy (ISS/ISE)
Statistical Reports
Statistical Review of Clinical Study Report (CSR)
Manuscript Development

Data Management

Ora’s expert Data Management and Electronic Data Capture (EDC) teams harness cutting-edge technologies to deliver unparalleled service to sponsors. With a wealth of experience in EDC implementation and decades of clinical operational excellence, Ora offers a seamlessly integrated technology stack tailored to the unique needs of your study. By combining our deep EDC expertise with industry-leading tools and platforms, we empower our clients with the resources and insights necessary to drive success at every stage of their clinical trials.

Our Data Management Services Include:

Protocol Review
Optimal Technology Solution Recommendation
Risk-Based Monitoring Strategies
24/7 EDC Helpdesk
EDC Access Administration
Data Management Trial Master File Set-Up and Maintenance
CRF Design and Development
CRF Completion Guidelines (CCG) Development
Subject Diary Design and Development
Data Management Plan Development
Data Validation Manual Development
EDC System Training for Sites and Monitors
Clinical Database Creation, Validation and Auditing

Edit Check Programming, Validation, and Testing
Development of Custom Status Reports
Adverse Event, Concomitant Medication, and Medical History Coding
Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, Diary, etc.)
Continuous Data Cleaning Throughout Study
Query Reconciliation
Independent QC Review
SAE Reconciliation between Safety and Clinical Databases
Database Lock
Study Archival

Take your practice to the next level with Ora.

With turn-key support systems in place, Clinical research gives you the opportunity to grow your practice and make a difference to those who matter most — patients.