Technology Tools

Success in clinical development relies on staying ahead of continuously evolving regulations. At Ora, we incorporate technologies that automate processes, comply with all required guidelines and regulations, and provide a higher level of quality for our clients. All of our systems are SaaS (web-based), allowing our staff to access them from anywhere, at any time.

Veeva Vault CTMS

Veeva Vault CTMS is a multi-tenant cloud solution that unifies clinical information and processes, streamline trial management, and gain complete visibility across the trial portfolio. Clinical study teams and sponsors have access to clinical master data with a single system of record for study, country, and study site information. Using Veeva Vault CTMS reduces the complexities of data integration from multiple manual systems, and increases transparency across stakeholders.

Faster trials
Real-time, actionable insights into trial status equip study teams with easy to use role-based dashboards, and streamlined navigation to improve productivity and speed trial execution.

Better decision making
A full view of your global operations in a single system enables proactive closed-loop issue management and improve strategic trial planning with a complete real-time view of trial status

Streamlined clinical operations
By unifying trial information and proactively identifying site issues, Veeva Vault CTMS eliminates manual processes to enable better study management, improving efficiency and streamlining operations.

Electronic Data Capture (EDC)

iMedNet EDC is Ora’s central source for electronic data capture. All study-specific EDC development activities, related documentation, and user system training are performed by our internal data management team. Our experienced team builds efficient and user-friendly forms, edit checks, and workflows for each study we develop – across multiple therapeutic areas based on the specific needs of the project. The technology is hosted by MedNet Solutions.

Electronic Trial Master File (eTMF)

Ora uses the Veeva Vault platform for eTMF. Configured around the DIA TMF Reference Model 3.0, the eTMF focuses on the comprehensive management of TMF-related information. Veeva allows the study team – including the project manager, clinical trial associates, regulatory writing team, monitors, and sponsor – to easily search the TMF for documents, create TMF status reports and navigate between tasks in real time. eTMF provides the flexibility and control required to operationalize SOPs and efficiently manage the TMF, allowing sites to focus on research with simplified document collection.

Study Start-up

Ora uses the Veeva Vault Study Start Up for Study and Site activation. Using the Veeva Study Start Up module, Ora has streamlined end-to-end study start-up processes to accelerate time to site activation. This technology allows Ora to make better, more informed decisions by actively monitoring and tracking site activation through dashboards, and reports.

Regulatory Information Management (RIM) Software

Ora implements Veeva RIM software, providing fully integrated regulatory information management capabilities on a single cloud-based platform – including submission document management, product registration management, health authority correspondence and commitments, and submission archiving. The visibility that results from a unified solution streamlines global processes and improves data quality, helping us respond faster to business changes and health authority requests. Using Extedo, Ora guarantees an efficient product registration and maintenance process by supporting the critical relationship between the pharmaceutical industry and regulatory authorities.

eCTD (Submission and Publishing Software)

Ora’s Regulatory Writing team uses the FDA Submission Gateway for electronic document submission. The eCTD system supports the effective management of validated and compliant submissions, with the ability to build, view, validate, and publish submissions based on standardized submission formats.

According to the FDA, the eCTD is the standard, accepted electronic format for the following submission types:

  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Investigational New Drug Application (IND)
  • Biologics License Application (BLA)
  • Master files: Drug Master File (DMF) and Biologics Master File (BMF)
  • Emergency Use Authorization (EUA)