Expanding medical information services across international borders poses unique challenges, especially in culturally and regulatory distinct environments like Japan. PrimeVigilance leverages its global footprint and extensive international expertise not only to meet local regulatory demands and cultural nuances but also to integrate and adapt best practices from other regions. This strategic synthesis, combined with our deep regulatory intelligence, enables the company to employ a multi-pronged and multi-step strategy, ensuring compliance with Japan's strict standards and effectively meeting client needs. Clients benefit significantly from the synergy between our local experts and our global reach, enhancing our capacity to tailor medical information services to the complexities of new regional markets. This approach reinforces PrimeVigilance's commitment to excellence and innovation globally, offering clients a distinct advantage in navigating diverse regulatory landscapes.
Navigating Global Medical Information Complexities
Medical Information (MI) departments play a crucial role in supporting scientific knowledge transfer, both to internal stakeholders and external customers, such as patients and healthcare professionals. With the ability to discuss off-label information, MI professionals must adhere to a strict code of ethics and ensure local regulatory compliance. MI activities, at their best, support patients and healthcare professionals to make informed choices on their care while providing actionable insights from these interactions to better support these groups in the future. Additionally, they are often an intake pathway for adverse event and product complaint information and so are vital in ensuring patient safety. MI professionals also utilize their expertise to support medical writing and regulatory decisions. The complexity of these tasks is heightened by the diverse regulatory landscapes and the nuanced differences in language and culture across various countries and regions.
To effectively manage these challenges, it is essential to identify commonalities where knowledge and training programs can be shared throughout the organization. This identification of overlap helps in designing technologies that cater to both shared activities and unique regional requirements, thereby fostering a more unified and efficient global operation.
Technological solutions should be adaptable, allowing for local customizations without compromising the integrity and uniformity of the global system. By leveraging robust and flexible technology platforms, medical information services can ensure that they not only meet the diverse needs of global markets but also maintain consistency in quality and compliance across all regions.
This strategic approach is crucial for navigating the intricate web of global medical information management, enabling pharmaceutical companies to deliver timely, accurate, and regulation-compliant information to healthcare professionals worldwide.
Addressing Global Expansion Challenges in Medical Information
Responding to a pressing client demand for localized support, PrimeVigilance embarked on a strategic expansion into the Japanese market. This venture was propelled by the necessity to swiftly establish region-specific medical information services in a region not previously covered by our in-house team. Initially, we collaborated with local expert vendors to quickly establish a foothold, aiming to transition these operations in-house to ensure consistent system and process integrity across our global operations.
Expanding medical information services into a new country like Japan requires meticulous planning and a deep understanding of distinct regulatory frameworks, along with the linguistic and cultural nuances that shape these markets. It is vital to identify discrepancies between our established global processes and the unique country-specific requirements, ensuring alignment with local standards and expectations concerning timing, cost, and quality.
When venturing into new markets, it is essential to comprehend local medical terminology, which may vary significantly from one region to another. For instance, the usage of medical terms, titles, and honorifics, and even the order of first and last names can differ, affecting data handling and communication processes. Additionally, the status of healthcare professionals, such as nurses, may vary, impacting how medical information is disseminated. Preferred methods of communication — whether through phone calls, live chat, self-service websites, chatbots, emails, or faxes — also require adaptation to local preferences.
In the initial stages of expansion, PrimeVigilance hired in-country local expertise to effectively navigate these complexities. These hires were crucial for establishing operations that met the rigorous standards of the new market while ensuring compliance with both local and international regulations. We were also able to leverage our global expertise to streamline processes and gain essential insights through our global technology infrastructure.
Providing in-house medical information services not only supports sustainable business growth but also fortifies PrimeVigilance’s commitment to providing localized and highly effective medical information services.
Tailoring Medical Information Strategies for the Japanese Market
For companies aiming to provide medical information services in Japan, establishing a local presence is imperative owing to specific legislative requirements.
All medical information services must be conducted in Japanese, unlike in Europe where English is an acceptable primary or secondary language for healthcare professional communication. This requirement presents a unique challenge due to the scarcity of bilingual professionals in life sciences and healthcare. Many Japanese people have studied English academically but often have limited practical use of English in a professional context. Therefore, a robust assessment of language skills, particularly in relation to medical terminology, is essential to verify fluency in English.
Moreover, Japan's cultural landscape imposes its own set of challenges for foreign entities. The expectation for calls to be answered within 10 seconds — significantly quicker than the 20-second norm in the Americas and Europe — demands adjustments in operational processes to meet these swift response times. In addition, in Japan, sales representatives (MRs) make a significant contribution to sales in the pharmaceutical market, and MI plays a supporting role for them. This requires reporting and escalation of queries to MRs as soon as possible after receipt (i.e., within 30 minutes to one hour) and coordination within the team to meet these client requirements.
At the same time, the hierarchical nature of Japanese society places a premium on etiquette and respect for authority and adherence to traditional customs. An example is the adaptation of keigo — a system of honorific speech — which can be difficult to use correctly when utilizing the phone. Companies must demonstrate a deep understanding of these cultural norms to successfully integrate into the Japanese market and build trust among consumers. Furthermore, the cultural tradition to show deference to established authorities can deter individuals from accepting and embracing new corporate entities, particularly if they have not demonstrated a fundamental understanding of Japanese business culture.
PrimeVigilance’s strategy involves not only adhering to these stringent requirements but also deeply integrating local cultural insights into their operations. We executed this by hiring local expertise well versed in local requirements and cultural norms. This approach has been vital in navigating the complex business environment and establishing a trusted presence in Japan. By aligning our operations with local expectations and legal requirements, PrimeVigilance ensures that their services are not only compliant but also culturally attuned, facilitating smoother interactions and greater acceptance from Japanese healthcare professionals and patients.
A Multi-Faceted Strategy for Global Medical Information Service Deployment
PrimeVigilance employs a comprehensive multi-pronged and multi-step strategy when entering new countries or regions to ensure its medical information services meet both local regulatory and cultural expectations, as well as specific client needs.
A pivotal component of our strategy in Japan involves the rigorous recruitment of key personnel who are proficient in both Japanese and business English. This bilingual capability in key roles is essential for ensuring seamless communication across our global and local teams, thereby enhancing our service delivery within the stringent Japanese regulatory and cultural framework. This has enabled us to provide nuanced, compliant medical information, effectively bridging the gap between global practices and local needs.
Our hiring process is meticulously designed to select individuals who are not only skilled linguistically but also deeply familiar with Japanese business etiquette and medical practices. This ensures our team can adeptly manage the complexities of medical queries, regulatory compliance, and client interactions without language barriers. By integrating local knowledge and focusing on linguistic and cultural proficiency, PrimeVigilance strengthens its capacity to deliver exceptional medical information services. This approach not only supports our clients’ ambitions but also contributes to improved healthcare outcomes across diverse markets.
A tailored communication style aligned with Japanese preferences ensured clarity and effectiveness when dealing with local client teams. Robust communication governance and strong working relationships with global contacts were also established to comprehensively oversee the project launch. Discussions with the client were aimed at aligning our procedures with their project-specific needs, and tailored training programs were instituted to ensure compliance with global SOPs, Japanese regulations, and the project’s unique requirements.
Furthermore, PrimeVigilance’s SOPs and Joint Operating Guidelines were revised to include country-specific processes and to develop Japanese-specific documentation, such as reporting forms and medical information response templates. This customization ensured that all materials were relevant and compliant with local standards.
Leveraging technological solutions proven successful in the United States and the European Union, PrimeVigilance quickly integrated these tools into the Japanese operations, maintaining consistency across regions. This integration included a system upgrade to support the direct entry of Japanese characters and the establishment of a new telephony system to manage local calls efficiently.
Adhering to stringent data privacy standards, PrimeVigilance aligned its operations with GDPR, setting a high compliance benchmark that aligns with and exceeds many of the current local Japanese requirements. This proactive approach not only ensures rigorous data protection but also builds trust and reliability among stakeholders, demonstrating PrimeVigilance’s commitment to maintaining the highest standards of privacy and security across all regions.
In 2021, the culmination of these efforts was marked by the opening of the Tokyo office, which now offers a full range of pharmacovigilance services, including comprehensive Japanese language medical information services, thereby solidifying PrimeVigilance’s presence and commitment to the Japanese market.
Aligning Global Medical Information Practices with User Needs
PrimeVigilance adopts a locally nuanced yet globally supported approach to the delivery of medical information services. This strategy is backed by a blend of country-specific expertise and extensive global experience, allowing us to operate efficiently across diverse regions. Our commitment to assembling the right team underscores our focus on retention and continuity, ensuring that each member possesses the ideal skill set to support our localized operations effectively.
Central to our mission is maintaining a relentless focus on the needs of our end-users, which include healthcare professionals and patients. While we strive for operational efficiencies, our primary aim is to meet and exceed customer expectations, even if it means opting for methods that may not be the most efficient but are the most effective for the situation. Our patient-centric approach guarantees that the medical information we provide is tailored in format, tone, and terminology to ensure clarity and accessibility for the intended audience.
Clients of PrimeVigilance benefit from our deep regulatory intelligence and the synergy between our local experts and our global reach. Our advanced technology and the integrated nature of our medical information and pharmacovigilance services set us apart from competitors, especially in how we manage to offer these services on a localized basis across multiple regions. This unique footprint enables us to discern what is most effective in each country and globally, fostering continuous improvement that benefits not only PrimeVigilance but also our clients and, ultimately, the patients they serve.
