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Comprehensive Pharmacovigilance Operations Provided – High Quality Supported by a Team of Experts

The world of medicine has become more advanced due to advances in molecular biology and genomic analysis, as well as the emergence of molecular target therapy and personalized medicine. As access to healthcare expands globally, the variety of drugs has increased, and the amount of safety information handled is also enormous. Therefore, the use of artificial intelligence (AI) is indispensable for information processing. In today, AI solutions are increasingly prevalent in pharmacovigilance (PV) operations.

We, WysiWyg Co., Ltd., have been providing safety operations support for many years. Our strength lies in our ability to provide the complete range of PV operations by experienced staff with in-depth knowledge and expertise. Our staff members perform total support for analysis, and the preparation of draft evaluation plans and reports both in Japanese and English in compliance with regulatory requirements with superior proficiency. Our translation skills are cultivated through long-term commitment to the translation of regulatory documents. This trusted expertise also contributes to the high quality of our services. We commenced full operations of PV for medical devices last fiscal year and strengthened its organizational structure to accommodate market demand, with continuously enhancing staff capabilities through internal training.

WysiWyg undertakes the entire range of support operations—from receipt of safety information to safety reporting to regulatory authorities and reporting to overseas headquarters or partner companies—or specific tasks thereof. Our outstanding start-up for contracted project is frequently cited as a reason why clients choose us, resulting in a high number of repeat clients.

Our strength in performing entrusted PV operations stems from the origins in translating safety information. Our involvement began with translating CIOMS (Council for International Organizations of Medical Sciences) reports, which facilitate the sharing of information on Japanese and overseas adverse events. Through this work, we developed not only translation capabilities but also deepened its understanding of interpreting CIOMS reports, the background and evaluation of safety information, reporting formats, and the management of safety information databases. We also refined our services by confirming client needs and establishing a responsive framework.

The volume of PV work has been increasing annually. While pharmaceutical companies face growing challenges and there is room for AI solutions, collaboration with staff possessing specialized knowledge and know-how remains essential. As globalization advances, opportunities to leverage our translation capabilities and expertise in the latest regulations continue to expand.

Our strength of having specialized knowledge and know-how in PV operations enables the effective handling of safety reports in response to overseas authorities’ requirements as well as the supporting of handling overseas safety reports in response to Japanese authorities’ requirements. Our operations of screening safety-related literature — including case reports and research reports from overseas—and of assisting with the preparation of draft evaluation plans and reports are fundamentally based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Pharmaceutical and Medical Device Act), while also relying on staff with strong reading comprehension and writing skills. We are also increasingly entrusted with safety management operations of global clinical trials by global CROs (Contract Research Organizations) and ICCCs (In-Country Clinical Caretakers). Global trials require action on cases within a time frame reckoned from the date of receiving overseas reports, demanding rapid response times alongside high levels of English proficiency and communication skills.

Our president and CEO, Mr. Ando emphasizes that while AI certainly enhances operational efficiency and speed, “high-quality safety information management requires highly skilled human staff with in-depth expertise and know-how, and we have highly competent in-house employees and leverage this strength to deliver our services.”

Within this framework, we have established a system for undertaking entrusted PV operations in the field of medical devices, which became fully operational during the last fiscal year. Medical devices often involve imported products from overseas, and each device has different characteristics requiring specialized knowledge distinct from pharmaceuticals. We reinforced our capacity by thoroughly implementing our expertise in employee training.

The necessary support system is constructed as products are personally viewed on-site at the manufacturers’ facilities. Our president explained, “As with pharmaceuticals, we believe our characteristic strength and advantage lies in collaborating with clients to cultivate relationships and deliver high-quality services.”

In a message to readers, our president, “Leveraging AI solutions to achieve high-quality PV operations requires specialized personnel. We see our role and service in providing that expertise,” emphasizing the importance of expert human teams in the AI era.

For more information on safety information management services,
https://www.wysiwyg.co.jp/en/service-en/safety/