| Dedicated Pharmacovigilance |
XTrials Research delivers superior quality safety services empowered by our innovative InFuse™ eClinical
technology. We offer our clients comprehensive and flexible solutions for clinical safety surveillance for Drugs,
Biologics, and Medical Devices that fully support their international obligations for timely adverse event reporting.
Our team of vigilant safety specialists bring in-depth experience of safety reporting and work in close conjunction
with client management to collect, track and analyze safety event content throughout all the phases of clinical
development. Our InFuse™ eClinical system offers a very cost-effective and efficient monitoring environment
supporting clinical trial safety surveillance. It provides a single integrated repository for all subject profile
data and other observations related to a safety event. The system design also systematically removes the need for
the separate reconciliation process necessary with other safety systems.
Safety surveillance stakeholders have direct access to developing safety events as they are recorded at the
investigative sites. When an adverse event is classified as "serious", members of the study safety team receive
automatic email notification that an event requiring their attention has occurred for the subject. They are
prompted to log into the secure workgroup environment to review the specific details. Safety users also receive
email notifications when this SAE content is updated or follow-up reports are submitted by the site. They can
query the site directly for data clarifications or uploading of HIPAA-compliant supporting documentation, and
prepare their safety narratives in the same integrated online collaborative environment. MedWatch and CIOMS
report forms are generated from clinical database content and produced in PDF format with full audit trail tracking.
Regulatory requirements for tracking SAEs are currently going through significant changes that will directly
impact the way you conduct your safety reporting responsibilities. Please contact us for a consultation.
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Safety Surveillance Services
- Safety Management Planning
- Clinical Protocol Safety Section Development
- Investigator and Site Training
- Pharmacovigilance
- Event Narrative Writing and Update
- Processing of SAE and UADE reports
- Preferred Term Encoding - MedDRA
- Database Integration and Migration Feed Generation
- Global Regulatory Reporting (Paper-FDA or Electronic-EMEA)
- Safety Reporting to Investigators, IRBs, ECs
- Periodic Safety Update Reports (PSURs)
- Annual Reports, End of Study Reports
- Global Safety Database Management
- Spontaneous Adverse Event Reporting
- Trend and Signal Detection
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| Precision Response |
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| Perceptive |
| Accurate |
| Vigilant |
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| Key System Features |
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Controlled capture of SAE/UADE |
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information via EDC/CDM system |
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Immediate email notification |
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to safety stakeholders of new |
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events and content updates |
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Full on-line access to case data |
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Integrated site query facility |
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Direct capture of supporting |
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documentation and summaries |
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Single platform solution for |
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narrative writing and reporting |
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Cross-study vigilance and analysis |
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tracking and warehousing |
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| Contact Us |
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