Streamline AE, PQC & MI call handling operations with Reportum

Call centres are typically responsible for a high percentage of safety report entry. However, the nature of the reporting process means it is hard to control, often involving complex fixed pdf forms that can lead to incomplete data and require follow-up to achieve the desired level of data quality. Reportum® is a highly scalable, centralised […]

Standardise safety data collection with Reportum

Understanding patient safety is an essential element of Patient Support Programs. However, traditional safety reporting systems involve multi-step manual processes that often result in compliance failures and late or unreported cases. Reportum® is a highly scalable, centralised solution that assists PSP nurse and call centre reporting to ensure standardised and complete data capture across third-party […]

Simplify safety reporting on-the-go with Reportum

Safety reporting is not a core focus for field-based staff, therefore inputting of reports is often completed at a later time. This means report entry is frequently incomplete and often delayed, which puts pressure on the safety team to comply with required timelines. Reportum® offers a simple, easy-to-use interface that guides the capture of relevant, […]

Capture patient data direct from source with Reportum

A complete picture of drug safety cannot be created if only part of the available data is captured, however the current adverse event capture process involves a maze of reporting routes across pharma companies and regional regulators. This creates a barrier to reporting, resulting in adverse events going unreported. Reportum® enables pharma to provide an […]

Standardizing and improving safety surveillance with Vigilance Workbench

A top 10 pharma company faced challenges in standardizing safety surveillance across Pharma, Vaccine, and Consumer Health units, including consolidating signal teams, facilitating a divestment, integrating multiple data sources, migrating data from legacy systems, replacing existing methods, and simplifying the IT landscape. The timely deployment of Qinecsa’s Vigilance Workbench significantly benefited the client by increasing […]

Compliant drug safety framework for early phase clinical trials

A biotech had successfully completed Phase I clinical trials and was rapidly progressing into Phase II. Serious adverse event (SAE) volume was expected to significantly increase and therefore associated workload could not be managed in-house. Qinecsa established a compliant and robust drug safety framework in line with budget and quality expectations to manage increased case […]

Cost-effective drug safety systems and solutions

A small pharma client with limited budget had several clinical compounds in Phase I and II, and one globally approved commercial product. They required robust processes for the evaluation of single and aggregate data to strengthen stakeholder review and documentation management associated with serious adverse events (SAEs).

Developing a robust drug safety framework

A small biotech with a healthy development pipeline had no internal pharmacovigilance expertise. They required a compliant drug safety framework to support safety data collection, evaluation, and dissemination during clinical trials. Qinecsa established a simple, compliant drug safety framework, including a suite of policies and procedures in line with relevant legislation, to support collection, evaluation, […]

Increasing Medical Information Call Center compliance and efficiency

A specialty pharma company were experiencing complaints regarding their existing Medical Information Call Center (MICC) due to a high call abandon rate. Qinecsa provided Medical Information Call Center services in eight languages to support global 24/7/365 coverage, ensuring sustained quality, compliance, and timeliness.

Rapid scaling of case processing services

A longstanding client approached Qinecsa with a business-critical mission to support case processing activities during the COVID pandemic. Qinecsa deployed a dedicated screening, recruitment, and onboarding team, including a project manager to manage all stakeholder expectations and a logistical team to support onboarding in a work-from-home environment.