PSI International
Entering a New Realm of Pharmacovigilance

The ever-increasing pressure to remain competitive in today’s volatile marketplace has driven pharmaceutical and biotech companies to leverage their R&D programs for innovative drug discovery and development. With such companies gaining interest in innovative drug development, the field of pharmacovigilance grows more significant for drug monitoring. The need for pharmacovigilance remains important for both the pre-market clinical trials as well as post-market studies in determining the safety and efficacy profile of every new medical product. The pharmaceutical and biotech companies will always require an effective solution to assess, understand, manage, and prevent the adverse effects of drugs that have reached the market. Dr. Samina Qureshi; a seasoned professional in pharmacovigilance, electronic data capture (EDC), epidemiology, and clinical data management leads PSI in addressing these opportunities.

With deep roots in health science, information technology, and regulatory science, PSI embarked on a journey to help federal agencies and commercial drug manufacturers embrace pharmacovigilance. As PSI International’s Vice President of Health Science and Pharma, Dr. Qureshi has been guiding her team to fulfill the company’s mission of assisting drug manufacturers in interpreting FDA regulatory compliance and implementing customized pharmacovigilance across every stage of the drug development lifecycle. “We are well-versed in 21 CFR Part 11 (code of federal regulations), and educate our clients on their deficiencies and adherence to FDA regulations via gap analysis and provide training and support services where needed,” states Dr. Qureshi.

Founded as a traditional information technology company, Virginia-based PSI International offers a blend of technology, health science, and social support services to federal and commercial clients across the world. PSI leverages its rich expertise in MedDRA (Medical Dictionary for Regulatory Activities) and WHO-DD (World Health Organization- Drug Dictionary) terminologies to help clients’ drug safety teams to assess and codify all incoming reports into the FDA Adverse Event Reporting System (AERS). The company has built an AI-powered front-end repository that utilizes natural language processing (NLP) and scanning to automate the AER process for the FDA in one of its projects. “PSI is one of the pioneers in implementing MedDRA and served as the first contractor to input standardized coded reports into the FDA AERS database,” Dr. Qureshi adds.

Apart from codifying the gambit of post-market observations and providing drug safety services, PSI goes the extra mile in pharmacovigilance by offering robust data analytics and signal detection services. In addition PSI supports the National Institutes of Health (NIH) with components of investigational new drug (IND) application development and submission with the CTEP (Cancer Therapy Evaluation Program).

PSI’s expertise in IT and health sciences, as well as pharmacovigilance, has opened a gateway for similar opportunities in the tobacco industry, called TobaccovigilanceSM. The company has patented the Tobaccovigilance service mark. TobaccovigilanceSM encompasses services provided by PSI relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with tobacco and tobacco related products. PSI delivers innovative solutions to tackle regulatory compliance for tobacco applications and empowers the tobacco industry with proper aggregation and analysis of the health effects reported by consumers or data from clinical and consumer studies.

PSI recently engaged with a client in the tobacco industry that required compliance with various components of the Tobacco Control Act (TCA), standardization of adverse health effect data, while also adhering to FDA regulations. PSI’s highly qualified and experienced team of physicians, pharmacists, and nurses seamlessly aggregated, codified, and organized the client’s legacy data into a set of standardized data utilizing FDA-preferred terminologies. With PSI’s accurate gap analysis and signal detection, the client could capture, codify and assess the severity and expectedness of their products’ adverse health effects. “We organized their health effect data and helped them develop standard operating procedures (SOP) and formulate coding guidelines to construct a robust, proactive set of data ready to be analyzed during FDA inspection,” explains Dr. Qureshi.

“PSI strives to create, mature, and materialize our products and services and develop automated tools uniquely tailored for the industries served, including pharmaceutical, tobacco, or emerging Cannabis industries,” says Charles Farris, VP of Business Development for PSI.

“We continue to be at the forefront of increasing efficiencies in both pharma and tobacco industries, and are currently working on an AI-based pilot project for medical review with the FDA to address the Agencies’ case review backlogs,” Dr. Qureshi concludes.