不良事件接收与随访

Row of customer service professionals wearing headset one person smiling at camera

作为医学信息 (MI) 处理的一部分,ProPharma 联络中心的团队从开始便接受过不良事件 (AE) 的侦测和接收的培训。 我们确保在每次与客户互动时收集每例 AE 以确保患者的安全、客户旅程和合规性。 为了提供无缝的体验,可以通过我们专门的药物警戒 (PV) 团队提供全面的 AE 处理和上报,以补充或完全包揽您现有的 PV 功能。

Collaborative, connected, and global

中心联络点

中心联络点

Decentralized Clinical Trials icon

以同理心为核心的服务理念

以同理心为核心的服务理念

Product compliant intake icon

识别与准确的上报不良事件

识别与准确的上报不良事件

Medical writing icon

记录与上报

记录与上报

Message received icon

处理随访

处理随访

Global contact center support icon

强化对账机制与安全监测

强化对账机制与安全监测

中心联络点

作为值得信赖的合作伙伴,ProPharma可作为您公司的延伸团队,涵盖上市前及上市后的各个阶段,成为您内部员工与外部客户之间的关键枢纽。我们掌握本地语言,能够通过多种报告渠道收集不良事件(AE)及特殊安全事件(SSE),包括电话、电子邮件等传统方式,以及社交媒体、在线聊天等新兴平台。ProPharma医学信息联络中心(MICC)提供集中化、流程化的不良事件报告机制,有效整合来自不同项目的重复信息,显著简化行政流程,缩短AE处理时间,提升整体效率。

我们的业务遍布全球,即使在危机情况下,客户也能轻松的联系上我们的联络中心。我们的策略具有可扩展性和适应性,可在电话量激增、法规发生变化或产品退出市场时提供持续的业务支持,并提供一致的医学信息和安全帮助。

Woman watching a health professional presenting on a laptop

以同理心为核心的服务理念

ProPharma的客户互动策略注重同理心,将治疗期间的不良事件 (TEAE) 转变为以患者为中心的体验。我们的医学信息(MI)专家接受过培训,能够以同情之心解决患者的特别顾虑,从而增进信任并提高满意度。通过倡导开放式沟通,我们营造出一个全面帮助患者的环境,从而改善了他们的预后,并促进了我们的客户与其利益相关者之间的良好合作关系。

Healthcare provider writing on clipboard while attending to a patient

识别与准确的上报不良事件

我们的 AE 接收流程可根据客户的具体需求来定制,从而精确地提高质量。我们经过认证的医学信息团队在识别 AE 与提供全面准确的报告方面经验丰富。为了确保他们始终站在不断发展的市场前沿,我们的专员不断接受培训以更新最新产品的知识和法规的要求。ProPharma 对继续教育的承诺促进了一致性并简化了质量监测,从而实现了无缝、高效的整体运作。

Customer service professional in a contact center wearing headset asking a coworker-a-question

记录与上报

ProPharma 提供与药物警戒 (PV) 系统(如 Oracle Argus 或 Veeva Vault Safety)对接的内部验证的数据库,旨在简化工作流程,方便直接传输 AE 案例,以便立即进行分流和审查。借助我们的先进系统,AE 病例可迅速传送给我们的客户或 ProPharma 的专业 PV 团队,以便及时进行评估和应对。此外,它还能触发向监管系统(即 FDA 不良事件报告系统 FAERS)的及时报告,以确保满足监管要求。ProPharma助力企业在确保合规与药品安全的同时,全面提升运营效率与流程优化水平。

Hand writing on clipboard with a pen

处理随访

通过联络中心处理不良事件的随访 (AEFU) 有几个显著优势。我们的专家团队接受过药物警戒规程方面的培训,能够确保在随访或后续跟进的电话或通信中收集到准确、相关的信息。ProPharma 向患者和医务人员提供积极主动的外联服务,以获取初次报告中可能未涉及的更多细节,从而更全面地了解不良事件。这种方法提高了运营效率,使您的药物警戒团队能够专注于数据分析和监管合规等关键任务。此外,我们标准化的跟进流程可提高数据收集的一致性,从而增强报告的可靠性并有助于安全评估。定期随访还有助于与患者和医务人员建立信任和互动,加强对安全和护理的承诺。

Row of customer service professionals wearing headsets

强化对账机制与安全监测

ProPharma的不良事件(AE)活动报告流程实现了每一例AE案例的全程可追溯,并提供对所有AE相关操作的深入洞察。我们利用系统化的文档来强化透明度和责任到人的制度。我们的自动化对账流程将 AE 案例与 MI 和 PV 系统进行校准,并在两个数据库中通过 AE 案例编号互相参照。通过访问我们专有的 “业务洞察与分析”(BIA)报告平台,您可以全天候获取全面的 AE 案例数据和指标。这一强大的系统可增强决策能力,并强化我们在患者安全和运营效率方面保持最高标准的承诺。

Person working on desktop and laptop devices
Person holding pen pointing to tablet device on a table

先进的药物警戒联络中心技术

通过IVR和呼叫转接技术实现高效分流

我们的交互式语音应答 (IVR) 系统和呼叫转接能力极大强化了我们的分流流程。通过高效地将电话转接给适当的客服人员,我们可以确保与不良事件 (AE) 相关的咨询得到及时准确的处理。这项技术极大地缩短了等待时间,改善了患者和医务人员的整体体验。

智能化报告生成

我们的智能报告生成工具可直接将受理流程中的内容自动合并,大幅降低手动报告可能引发的错误风险。这种简化的案件处理流程不仅提高了准确性,还加快了重要报告的生成速率。因此,我们的团队可以将更多的时间用于关键的安全评估,且降低了行政工作的负担。

自动化随访

我们的自动化随访系统简化了通过书面沟通发送表格和收集其他信息的流程,大大减少了行政工作量。通过将这些随访任务自动化,我们确保了与利益相关者的及时沟通,同时释放了您团队中的宝贵资源。这种效率提高了我们准确并全面记录AE各方面信息的能力。

Two data professionals reviewing data on computer monitor
Hands typing on tablet device

重复报告的高级分析

借助先进的分析工具,我们可以有效地核对重复的报告和信息。这种能力有助于识别差异,并确认所有数据都准确地显示在系统中。我们能提高数据的完整性,这对于做出明智的安全决策和保持监管合规至关重要。

Our Adverse Event Intake Experts

  • Dave Bezick Bio Photo

    Dave Bezick

    Senior Director, Medical Information

    View Bio

  • Hannah Hunter Bio Photo

    Hannah Hunter

    Senior Director, Medical Information

    View Bio

  • Katie Tonge Bio Photo

    Katie Tonge

    Senior Director, Medical Information

    View Bio

  • Leanne Shaw Bio Photo

    Leanne Shaw

    Senior Director, Medical Information

    View Bio

Dave brings over 15 years of Medical Information Contact Center Management and Operations experience. A licensed Registered Nurse, he began his career as a front-line Medical Information Specialist and has continually advanced into roles of increasing responsibility within the Medical Affairs industry. He is currently the Senior Director, Medical Information Service Delivery (Operations and Account Management) at ProPharma. Dave's passion for the patient and HCP experience is evident in his approach to staff selection, employee development and operational excellence of his teams.

Hannah is the Senior Director of Medical Information (MI), Europe at ProPharma, where she leads dedicated client services across the continent. With 18 years of experience in Medical Information, Hannah has supported pharmaceutical companies globally. She is passionate about the evolution of MI to better meet the needs of customers and clients. As a proven leader, Hannah excels in guiding and inspiring her team to achieve excellence. She places a strong emphasis on the provision of telephone-based MI, recognizing its importance as the primary channel for MI inquiries and its potential for excellent service delivery. Additionally, she is focused on leveraging technology to enhance the efficiency and effectiveness of medical information teams.

Katie has over 16 years of Medical Information outsourcing experience, as well as contact centre management, and is passionate about using Medical Information to improve the health and safety of patients. She enjoys working with clients to suggest innovative and commercially sustainable options for their Medical Information needs. She has a track record of establishing service levels and KPIs with clients to ensure the highest standards for customers.  She also has Project Management experience in helping clients transition from in-sourced services to an outsourced Medical information solution.

Leanne brings 15 years of Medical Information Contact Center Management and Operations experience across Europe and Asia Pacific. Leanne begun her career in this space as a UK Medical Information Specialist and has continually advanced into roles of increasing responsibility including client management, operations management, and project leadership. Leanne is currently the Senior Director of Medical Information Services for JAPAC at ProPharma. Leanne’s key focus on service evolution and customer excellence helps deliver JAPAC services to the highest standard of success.