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| Medical
Safety Monitoring Services |
| Qtech solutions
provide the Drug safety and pharmacovigilance services in
the complement of clinical research services to assist the
sponsors in the development and commercialization of new therapies.
Qtech Solutions staff is equipped to provide full support
to meet your clinical development needs. We provide Sponsors
with the reassurance that comes with years of industry expertise,
on a 24x7 basis, to support clinical operations with a safety
desk, protocol waiver, and other time-sensitive expert services. |
| Our
service offerings include |
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Medical safety monitoring and reporting
for Phase I - IV drug studies.
- Collection, assessment, submission,
and follow-up of reportable adverse events for:
o Immediately Reportable Adverse Events (IRAEs).
o IND safety reports.
o Serious Adverse Events (SAE).
- Narrative preparation.
- 24-hour on-call services (medical monitoring).
- Expedited United States (US) and international
case reporting .
- Reconciliation of AEs and safety databases.
- Preparation and submission of US Periodic
Reports and Periodic Safety Update Reports (PSURs).
- Data Safety Monitoring Boards.
- Audits of safety processes.
- Risk management, trend and signal detection.
- Documentation of business requirements
for database systems and Standard Operation Procedures
(SOPs).
- Business consulting to review client
safety systems and processes Randomization, unblinding.
- Temporary staffing with experienced drug
safety personnel.
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