Have a requirement?
Chat with us
Have a requirement?
Chat with us
Nature of Business
Service ProviderStatistical Services
Get Latest Price
- Statistical section for study protocols
- Sample size power calculations
- Statistical/Data Analysis Plan
- Data analysis, and tables, listings and graphs
- Interpretation of results for study reports.
View Complete Details
Medical Writing Services
Get Latest Price
- Safety Narratives (CSR, DSMBs, etc.)
- Clinical Summaries/Product Feasibility Reports for Medical Devices
- Clinical Study Protocols
- Clinical Study Reports (ICH-E3)
- IND Annual Reports (21 CFR 312.33)
- Annual Safety Reports (Directive 2001/20/EC and ENTR/CT3 Sec 5.2)
- Development Safety Update Reports (ICH-E2F)
- Manuscripts and Publications
- Patient Diary Cards (PDC), Informed Consent Form (ICF), Subject Information Sheet (SIS), Case Report Forms (CRFs).
View Complete Details
Single Case Processing-Clinical Trial Reports Services
Get Latest Price
These are adverse event reports originating from clinical trials involving investigational products. Only serious events and non-serious events of special interest are reportable to the health authorities. Such events may be considered related or unrelated to the investigational product by the investigator/client.
View Complete Details
Single Case Processing-Spontaneous Services Reports
Get Latest Price
These can be serious or non-serious event reports from the following sources, originating after a product has been marketed by the Marketing Authorization Holder (MAH):
- Government agencies
- Industry
- Hospitals
- Academia
- Medical and Pharmaceutical Associations
- Poisons and Medicines Information Centers
- Health Professionals
- Patients
- Consumers
- Media.
View Complete Details
Single Case Processing-special Reports
Get Latest Price
Single Case Processing-special Reports-Literature Reports Service
These are all case reports where an adverse event associated with a marketed or investigational product has been generated from a systematic search of commercial scientific databases of published peer-reviewed journal articles. In these, only a generic name of the marketed or investigational product may have been reported, and quite often the manufacturer cannot be determined.
View Complete Details
Single Case Processing-Related Services -Medical Review
Get Latest Price
After case processing is complete and before submissions to the health authority, the case is reviewed by a physician or a healthcare professional to confirm the medical cohesiveness of the data that is going to be submitted. The medical reviewer or assessor checks the labeling that has been added by the case processor, and checks the narrative and the CIOMS comment to ensure that it makes medical sense. Any missing medical information is requested at this stage.
View Complete Details
Single Case Processing-Related Services
Get Latest Price
Single Case Processing-Related Services-Medical Triage Service
Individual case reports received from clients are reviewed by the healthcare professionals and physicians to check for proper classification, and assessment of their priority and compliance timelines that need to be followed. The priorities depend on the seriousness of the event, the causal relationship, and the product involved.
View Complete Details
Related Services-Signal Detection Services
Get Latest Price
As part of the signal detection process, QSI performs several services for its clients:
- Literature reviews
- This involves reviewing literature abstracts and complete articles, retrieved in a commercial keyword-based search from established databases. Single case safety data is not considered in this service.
- Event analyses and Issue work-ups
- QSI performs EFI (Events for Further Investigation) analyses and report writing services, as well as the medical analyses of case reports included in signal work-ups
- Proportional Reporting Ratio analyses
- PRR analyses may be undertaken for clients, if required.
View Complete Details
need
details