本研究旨在探討高合規環境下，專案治理如何影響醫藥產業中檢測服務與病患支持計畫之設計、執行及生命週期決策，並進一步分析其與品牌信任之間的可能關聯。隨著台灣醫藥產業同時受到外部法規、產業自律規範及跨國企業內部治理要求之約束，檢測服務與病患支持計畫已不再只是單純的資源提供，而是涉及病患未滿足需求驗證、跨部門審查、第三方執行單位管理、資料治理、KPI 監測及退場安排等多重治理議題。

本研究採質性個案研究法，以在台某跨國藥廠作為個案公司，選取三項檢測與病患支持相關專案進行比較分析，包括法布瑞氏症 DBS 血片及基因檢測專案、IBD 糞便鈣衛蛋白檢測專案，以及卵巢癌 HRD 基因檢測補助專案。研究資料來源包括半結構式深度訪談、法規與產業自律文件、企業內部治理文件及專案執行資料。受訪者涵蓋個案公司內部之醫學部門主管、醫學治理主管、道德與合規主管及法務主管，另納入外部商務部門專家、醫院端醫師／管理者，以及具護理專業與病患家屬經驗之受訪者，以取得企業治理端、產業實務端、臨床端及病患照護端之多元觀點。

研究發現，第一，PSP／DTS 專案之正當性須建立於明確的病患未滿足需求與臨床互補性，而非僅基於企業資源、醫師期待或商業考量。第二，高合規治理並非只是增加行政審查程序，而會實際影響專案之服務範圍、合作模式、角色分工、資料流向及執行架構。第三，外部醫療生態系會影響藥廠投入之必要性；當醫學會、病友組織、醫療院所或其他資源能回應需求時，企業應重新評估其投入是否仍具補充性與差異化價值。第四，專案停止或結束不代表治理失敗；若具備清楚的停止條件與理由、正式決策紀錄、一致的內外部溝通及適當的服務銜接，負責任退場亦能展現生命週期治理之成熟度。第五，品牌信任並非直接來自企業提供免費檢測或經費補助，而可能透過外部利害關係人對企業治理行為的長期觀察逐步形成，包括專案正當性、醫療決策獨立性、流程透明性、角色與資料界線、第三方執行單位管理，以及持續監測與退場管理。

在理論解釋上，本研究以服務主導邏輯、轉型服務研究及資源基礎觀點作為補充分析視角。研究結果顯示，專案服務價值須透過企業、醫療院所、醫師、實驗室、第三方執行單位及病友組織之互動與資源整合共同形成；專案治理亦須關注其對病患、家庭及醫療服務生態系福祉的影響；而跨部門協作、資料治理、第三方管理及生命週期管理能力，則可視為企業整合內外部資源的重要治理能力。

本研究之管理意涵在於，醫藥企業應將合規專案治理視為協助判斷專案啟動、執行、調整與退場的管理工具，並作為品牌信任形成的制度化基礎。企業推動 PSP／DTS 專案時，應由病患旅程與病患未滿足需求出發，建立早期跨部門治理與分階段審查機制，將第三方執行單位、品牌信任風險及退場安排納入完整生命週期管理。透過一致、透明且貼近臨床實務的治理行為，企業較可能累積外部利害關係人對其專業性、可靠性、誠信與病患導向之信任。

This study explores how project governance in a high-compliance environment influences the design, implementation, and lifecycle decisions of diagnostic testing services (DTS) and patient support programs (PSPs) in the pharmaceutical industry. It further examines the possible relationship between project governance and the formation of brand trust. Pharmaceutical companies in Taiwan operate under multiple layers of requirements, including external regulations, industry self-regulation, and internal governance standards established by multinational corporations. Consequently, DTS and PSP initiatives are no longer limited to the provision of patient services or financial resources. They involve multiple governance considerations, including the validation of unmet patient needs, cross-functional review, third-party management, data governance, KPI monitoring, and exit planning.

This study adopts a qualitative case study approach and focuses on a multinational pharmaceutical company operating in Taiwan. Three DTS/PSP-related projects were selected for comparative analysis: a Fabry disease dried blood spot and genetic testing project, an inflammatory bowel disease fecal calprotectin testing project, and an ovarian cancer homologous recombination deficiency genetic testing support project. Data were collected through semi-structured in-depth interviews, regulatory and industry self-regulatory documents, internal governance documents, and project implementation materials. Interviewees included internal leaders responsible for medical affairs, medical governance, ethics and compliance, and legal affairs. The study also included an external commercial-function expert, a hospital-based physician or manager, and a participant with nursing and patient-family experience, thereby incorporating perspectives from corporate governance, industry practice, clinical care, and patient support.

The findings indicate that, first, the legitimacy of PSP/DTS projects must be grounded in clearly identified unmet patient needs and clinical complementarity, rather than solely in corporate resources, physician expectations, or commercial considerations. Second, high-compliance governance does not merely add administrative review procedures; it substantially reshapes service scope, collaboration models, role allocation, data flows, and implementation structures. Third, the external healthcare ecosystem affects the necessity of direct pharmaceutical-company involvement. When medical societies, patient advocacy organizations, healthcare institutions, or other support resources already address part of the identified needs, companies should reassess whether their participation continues to provide complementary and differentiated value.

Fourth, project termination or completion does not necessarily represent governance failure. Responsible exit may demonstrate mature lifecycle governance when it is supported by clear termination criteria and rationale, formal decision records, consistent internal and external communication, and appropriate service transition arrangements. Fifth, brand trust is not created simply through the provision of free testing or financial support. Rather, it may gradually develop through stakeholders’ long-term observations of corporate governance behavior, including project legitimacy, clinical decision-making independence, process transparency, clear role and data boundaries, third-party management, ongoing monitoring, and exit governance.

Service-dominant logic, transformative service research, and the resource-based view were used as supplementary theoretical perspectives. The findings suggest that service value is jointly formed through interactions and resource integration among pharmaceutical companies, healthcare institutions, physicians, laboratories, third-party service providers, and patient advocacy organizations. Project governance must also consider its effects on the well-being of patients, families, and the broader healthcare service ecosystem. In addition, cross-functional collaboration, data governance, third-party management, and lifecycle management may constitute important organizational capabilities through which companies integrate internal and external resources.

The managerial implication of this study is that pharmaceutical companies should treat project governance as a management mechanism for determining whether and how projects should be initiated, implemented, adjusted, or terminated, as well as an institutional foundation for brand trust. When developing PSP/DTS projects, companies should begin with patient journey mapping and unmet patient needs, establish early cross-functional governance and staged review mechanisms, and incorporate third-party management, brand trust risk assessment, and exit planning into lifecycle governance. Through consistent, transparent, and clinically grounded governance practices, companies may strengthen stakeholders’ perceptions of their professionalism, reliability, integrity, and patient orientation.

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