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| - | clinical research & project management |
| - | clinical development planning |
| - | regulatory affairs |
| - | medical writing |
| - | quality assurance |
| - | pharmacovigilance |
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Services | Pharmacovigilance The ORION Pharmacovigilance / Drug Safety group is based across both our UK and US offices, and includes a number of Drug Safety Physicians and Drug Safety Executives. ORION’S standalone pharmacovigilance system, PV-Works®, has the flexibility of function to allow us to tailor the service we provide to our sponsors’ needs. It supports standard dictionaries including MedDRA and meets worldwide regulatory requirements. It also allows us to generate customer specific reports in addition to electronic submissions for regulatory authorities or Ethics / IRBs, and has comprehensive security functions. ORION has also developed a robust process for the management of pharmacovigilance data, including a 24 hour, 7 day a week emergency contact number for SAE reporting. Our services include:
The ORION WebServer has been specifically developed as a collaborative web portal solution that connects people, teams, and information together using one common secure interface. Developed on a Microsoft platform it enables organisations to integrate business processes and applications, as well as to provide a full set of collaboration and personalisation features. The system is scalable, reliable, easy to use and easy to manage. The WebServer allows confidential, shared access to any document that is posted (i.e. safety data, safety listings, patient recruitment tracking information, final key documents etc). The WebServer will be accessible to the entire SPONSOR-ORION project team, and will offer different levels of access for each individual dependent upon their position within the team. Key functions of the WebServer include:
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