Translations for the medical research field require the shortest turnaround times and the highest levels of accuracy.
Regulations are strict and submission processes are long and costly. Patient safety and data confidentiality are critical. Errors can be catastrophic for both your company’s reputation and for patients.
OmniLingua meets these rigorous demands through extensive knowledge and experience from our specialized linguists. Together, our team makes certain you receive the highest quality localization services—within your budget and time constraints.
- Dossiers
- Informed consent forms
- Site reports
- Patient reported outcome
- Medical safety reports
- Data correction forms
- Effectiveness studies and more
Quality Processes
OmniLingua is third-party certified with several ISO certifications and complies with HIPAA and FDA 21 CFR Part 11. A critical part of our translation operations consists of following Good Documentation Practices and Good Clinical Practices (GCP), attending to matters of compliance and providing Linguistic Quality Assessment. Learn more about our dedication to quality processes.
Customized Technology for Medical Safety Reports
To support the global management of clinical study safety reports, OmniLingua offers our clients a controlled localization process that meets all Safety Trial Operations requirements with access to a secure clinical safety portal to allow global 24/7 project submission and management. Clinical and safety department stakeholders use the portal for file transfer, project approvals, logging project correspondence, and management of the change request process. All access and activity within the portal is governed by permission levels with strict user right systems and authorization. Since 2009, this system has been in use for more than 20 long-term global multi-site studies to our clients’ great satisfaction.
Take advantage of our expertise and proven processes for Clinical Research localization.
