Complexities and regulations constantly change within the life sciences industries. Here at Ora, we try to stay in front of all these requirements by incorporating technologies that not only automate some of these processes, but also comply with all the guidelines and regulations required, as well as provide a higher level of quality for our clients. All of our systems are SaaS (web-based), so our staff has the ability to access the systems from anywhere, at any time, provided they can connect to the internet.
Some of the technologies we utilize are:
Veeva Vault CTMS
Veeva Vault CTMS is a multi-tenant cloud solution that unifies information and documentation for a single source of data across clinical operations. Sponsors, CROs and investigators have access to clinical master data with a single system of record for study, country, and study site information. The use of Veeva Vault CTMS reduces the complexities of data integration from multiple manual systems, and increases transparency across stakeholders.
Benefits of the system include:
- Faster trials: Real-time, actionable insights into trial status improve efficiency and performance.
- Better decision making: A full view of your global operations in a single system enables more strategic trial planning.
- Streamlined clinical operations: By unifying trial information and proactively identifying site issues, Vault CTMS eliminates manual processes to enable better study management.
Risk Based Management (RBM): Remarque Systems
RBM is a comprehensive software application for designing, deploying, and managing Risk-Based Monitoring trials. The system uses advanced visualizations, analytics, and machine learning for robust risk prediction, detection, analysis, and management.
Ora uses Remarque System’s SaaS Platform for the design, deployment and management of RBM clinical trails. Capabilities of the Remarque System’s SaaS Platform include:
- Signal Driven SDV™ uses triggers established prior to study start combined with machine-learning capabilities to make better monitoring decisions
- Built-in risk assessment & mitigation module
- System agnostic data intake can consume data from any source in any format without the requirements of a data warehouse
- Role-based remote monitoring supporting roles for managing site, patient, and protocol level risks
- Purpose-built integrated workflow solutions designed to scale as needed
- Intuitive, interactive, role-driven visualizations with complete drill-down capabilities
- Robust workflow functionality built into every role to easily convert findings to trackable actions
- Knowledge engine that uses machine learning combined with classical statistical models to predict, detect, analyze, and manage risk
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 with their involvement at a study level being purely related to technology hosting support services.
Electronic Trial Master File (eTMF)
Ora utilizes the Veeva Vault platform for eTMF. Configured around the DIA TMF Reference Model, the eTMF focuses on the comprehensive management of TMF (Trial Master Fial)-related information. Veeva allows for 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.
Regulatory Information Management (RIM) Software
Ora implements Extedo 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 this critical relationship between the pharmaceutical industry and regulatory authorities.
eCTD (Submission and Publishing Software)
Ora’s Regulatory Writing Group has recently initiated electronic submission of documents to the FDA through the FDA Submission Gateway. In May of 2018, all submissions to FDA will be required to go through this electronic gateway. The eCTD system allows effective management of validated and compliant submissions; we now have 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)