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, […]
Transforming data into decisions
Dr Andrew Rut recently presented at the PV Legal Forum in Chicago on the importance of collecting and analyzing holistic safety data in order to make good decisions for individual patients needing treatments. Disconnected systems lead to gaps and errors in the pharmacovigilance process: There is a lack of information at market authorization as clinical […]
Join Qinecsa at 31st Pharmacovigilance 2023, 1-2 February, London
Join Qinecsa at 31st Pharmacovigilance 2023 to discuss the latest developments in pharmacovigilance, drug safety & risk management. Humaira Qureshi, President, Qinecsa Solutions, will present ‘Fit for Future Sourcing for Pharmacovigilance’ on 1 February at 12:10pm. Get in touch to book a meeting with us at the event and find out how Qinecsa can […]
Stanley Capital-backed portfolio company Qinecsa acquires Commonwealth Informatics
Stanley Capital Partners LLP (SCP) has announced the acquisition of Commonwealth Informatics, Inc. (Commonwealth) by its portfolio company Qinecsa Solutions UK Ltd. (Qinecsa), a leading provider of pharmacovigilance services and technologies to the global pharmaceutical industry. The financial terms of this transaction are not being disclosed. Headquartered in Massachusetts, USA, Commonwealth, an independently-operated subsidiary of […]
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.
Qinecsa pharmacovigilance consulting guide
Pharmacovigilance consulting is essential throughout the entire lifecycle of both commercial and clinical products. At Qinecsa, a company with a strong focus and heritage on pharmacovigilance consulting, with years of successful safety services delivery enhanced by our innovative technologies, we are a proven, trusted partner to the life science industry. We have successfully helped clients […]
Join Qinecsa at 6th ISoP Seminar, Boston
Dr Andrew Rut, Senior Executive at Qinecsa will be attending the 6th ISoP Seminar on 5-6 December in Boston, US. The seminar theme is ‘Intelligent Automation in Pharmacovigilance’ and Dr Rut will share insights into how the use of technology solutions can address PV challenges in a more holistic way during his presentation ‘Transforming Data […]
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.
