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Qsi Is A Specializing In Drug Safety Clinical Research Services

Quantum Solutions India is a contract research organization specializing in drug safety Clinical Research Services. QSI provides single-case and aggregate-report processing services such as Individual Case Safety Reports (ICSR) and Periodic Safety Update Reports (PSUR) to the world pharmaceutical industry.

Single-case processing services involve collating and interpreting ICSRs originating from the following sources:

- Spontaneous Reports

Spontaneous Reports processed by QSI are serious or non-serious event reports, which themselves originate”after a product has been marketed by the Marketing Authorization Holder (MAH)”from the government, industry, hospitals, academia, medical and pharmaceutical associations, poisons and medicines information centers, health professionals, patients, consumers and media.

- Clinical Trial Reports

QSI processes adverse-event Clinical Trial Reports originating from clinical trials involving investigational products. Besides serious events, non-serious events”classified as related or unrelated to the product by the investigator/client”of special interest are reported to health authorities. QSI also provides Serious Adverse Event Case Narrative Writing services for reports originating from clinical trials. Such reports are submitted after the data lock point and submission of the ICSRs to the health authority.

- Special Reports

Special Reports comprise legal and literature reports.

Legal reports originate from lawsuits and are usually handed over to QSI by the MAH's legal department. Such reports contain a list of adverse events ('damages') that prompted the legal action. Legal reports may have a number of sources, including plaintiff fact sheets, medical records, electronic communications (e-mail, facsimiles and the like), jury trial demand notifications, deficiency letters and administrative/judicial summons.

Literature reports are case reports of adverse events associated with a marketed or investigational product. Published peer-reviewed journal articles”which mention the generic term of the marketed or investigational product”form the basis of such reports.

QSI employs Medical Dictionary for Regulatory Activities (MedDRA) coding to enter data received from clients into a drug safety/pharmacovigilance database after a duplicate search.

- Related Services

QSI standalone services comprise Medical Review, Medical Triage, and Serious Adverse Event (SAE) Reconciliation Projects.

Medical Review involves the verification”by a physician or healthcare professional”of the medical cohesiveness of the data to be submitted to the health authority. The reviewer checks the labeling added by the case processor, the narrative and the CIOMS (Council for International Organizations of Medical Sciences) comments to ensure all make medical sense and are free of errors. Any information that is missing is also requested at this stage.

In Medical Triage, physicians and healthcare professionals check individual case reports received from clients for classification accuracy, to assess and allocate priority and find out the compliance timelines that need to be followed. Prioritization is subject to the seriousness of the event, causal relationship and the marketed or investigational product.

QSI undertakes disparate Serious Adverse Event (SAE) Reconciliation Projects. A relatively common project is reconciliation of SAE data of the client's drug safety/pharmacovigilance database with that of the relevant clinical database(s).

Aggregate-report processing involves the analysis and incorporation of grouped data into the following reports:

- Periodic Safety Update Reports (PSUR)

PSURs must comply with applicable regulatory requirements. They are written by physicians working closely with clients. The work may involve various tasks, including assessment, prioritization, narrative writing, reviewing and compiling.

- Addendum PSURs

Addendum PSURs are interim reports written usually for a shorter review period. However, the process is similar to that followed in creating the standard PSUR. Addendum PSURs usually omit individual case narratives.

- Summary Bridging Reports (SBR)

SBRs are often overviews of 4 to 5 PSURs. Their sections are the same as those of the PSURs.

- Six-monthly SUSAR Reports (SSR)

SSRs serve the purpose of informing Ethics Committees and competent authorities about Suspected Unexpected Serious Adverse Reaction (SUSAR) incidents detrimental to trial subjects. They usually include a brief report of the SUSAR cases and are reported for the drug and/or an associated comparator along with associated line listings.