市場準入
Helping You Formulate a Market Access Strategy that Maximizes Access for Your Brand
With more expensive drugs winning regulatory approval and increased scrutiny on drug pricing, market access has never been more challenging and competitive. Our team offers a full spectrum of solutions and services to help you navigate the market access landscape and maximize access for your brand.
Optimizing Access to Markets Throughout Your Brand’s Life Cycle
Wherever you are in your brand’s life cycle, there is a team that can help you to achieve your access-related objectives. From research to strategy and tactical execution, we offer a comprehensive suite of services to give your brand and organization a competitive edge every step of the way.
A Complete Toolbox for Global Market Access
Whether it’s gathering market information or conducting cost analyses, we have the depth and resources to give our customers the insights they want and need. We bring these insights to life through our analytics, as well as our creative executions, generating captivating content that best communicates our customers’ strategy-driven messages.
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Our Global Market Access Offering:
- Market assessment and analysis
- Comparative effectiveness research
- Pricing reimbursement and HEOR
- HCEI communications
- Patient assistance services
- Legislative and regulatory analysis
A Fit for All Shapes and Sizes
Whether you’re working for a company with a history of blockbuster launches or a start-up with a promising pipeline, we can help you develop and implement your market access strategy. Our multiple teams have collective experience across the healthcare continuum and can provide the support and services specific to your organization and brand, always tailoring them to help you overcome your brand-specific access challenges.
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Close Connections on a Global Scale
With experienced teams in multiple countries, we understand the policies, trends and nuances in markets around the world.
BUILDING AND COMMUNICATING STRONG AND EFFECTIVE VALUE PROPOSITIONS
The complex, heterogeneous, and rapidly-changing payer environment is becoming increasingly difficult to navigate. Our expert teams of industry leaders, former payers, policy experts, and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to help you achieve optimal price and access. Our team of communication specialists can help you develop compelling arguments presented in an accurate, succinct, and engaging story format to shape effective payer positioning and position evidence to overcome payer objections.
WE CAN HELP YOU
Gather in-depth information on the HTA, pricing, and reimbursement drivers and limiters, as well as landscape reviews, analog and market assessments
- Develop comprehensive global pricing and market access strategies and recommendations
- Develop evidence generation strategies to support optimal value positioning, HTA assessment, and pricing
- Support in-licensing decisions with rapid turnaround insights into global pricing and reimbursement potential
- Provide cross-functional alignment on pricing, access and evidence strategies through market access workshops
- Craft value stories that articulate a logical flow of arguments, supported by available evidence
- Test, refine, and validate value messages with relevant stakeholders
- Present payer-relevant evidence through global value dossiers, slide decks, objection handlers, and training
- Develop country-specific pricing and reimbursement or formulary submissions, including Academy of Managed Care Pharmacy (AMCP) dossiers for U.S. payers and HTA submissions for various markets
- Convey messages and evidence in a dynamic, user-friendly way electronically through?iValue Suite
- Explore key market access hypotheses through international payer advisory boards
WE OFFER YOU
- A network of over 2,000 payer experts and advisors worldwide
- A Pricing and Reimbursement Policy Council (PRPC) comprised of a diverse group of industry experts, and providing insights into the latest issues, trends, and changes affecting market access
- Expertise and experience in over 45 countries and across all major therapeutic areas
- In-house expertise and no outsourcing, with ~35,000 payer interviews and all value story and dossier writing done internally
- Rigorous quality standards applied to all content development
ADDRESSING THE LATEST TRENDS IN MARKET ACCESS
- Advanced Therapy Medicinal Products
- Early Access
- Expanded Access
- Conditional Marketing (e.g,, for Orphan Drugs)
- Medical Devices
- Price Referencing
- Surrogate Endpoint Use
- Transparency in Drug Pricing
研究項目管理
Effective communication of evidence and information is essential to conveying the value of your products, both to internal and external stakeholders. With approximately 20 years of experience, our highly trained staff provide medical writing services for the peri- and post-approval phases of the product lifecycle, guaranteeing a consistency in quality and voice. Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully compliant with regulations, industry best practices, and your corporate guidance.
- Site Identification
- KOLs networking
- PI Training
- Clinical Audit
- online SMO
上市后研究
專業團隊為中國上市后研究助力
梅斯醫學真實世界研究BU在上市后臨床研究的設計和執行方面具有廣泛的經驗。我們的研究通過結構化的研究設計和執行產生有影響的醫學數據,以及產品或特定患者群體的醫學證據,以更好地指導臨床實踐,實現最市場準入和最優商業,并滿足監管當局的要求。我們所有的研究都是按照GCP規范和相應研究指南進行的。
梅斯醫學開發針對上市后研究的精簡且經濟有效的標準操作規程,最大限度地收集數據、監控和質量,同時最大限度地減少操作風險。
梅斯醫學真實世界研究團隊具有深厚的政策和專業知識,包括倫理和監管要求、患者隱私立法、調查人員補助政策、學術和網站網絡、患者協會、國家衛生數據庫和本地衛生保健系統
卓越的研究設計與執行
梅斯醫學真實世界研究BU在上市后臨床研究的設計和執行方面具有廣泛的經驗。我們的研究通過結構化的研究設計和執行產生有影響的醫學數據,以及產品或特定患者群體的醫學證據,以更好地指導臨床實踐,實現最市場準入和最優商業,并滿足監管當局的要求。我們所有的研究都是按照GCP規范和相應研究指南進行的。
梅斯醫學開發針對上市后研究的精簡且經濟有效的標準操作規程,最大限度地收集數據、監控和質量,同時最大限度地減少操作風險。
梅斯醫學真實世界研究團隊具有深厚的政策和專業知識,包括倫理和監管要求、患者隱私立法、調查人員補助政策、學術和網站網絡、患者協會、國家衛生數據庫和本地衛生保健系統
藥品重點監測
梅斯醫學真實世界研究BU在上市后臨床研究的設計和執行方面具有廣泛的經驗。我們的研究通過結構化的研究設計和執行產生有影響的醫學數據,以及產品或特定患者群體的醫學證據,以更好地指導臨床實踐,實現最市場準入和最優商業,并滿足監管當局的要求。我們所有的研究都是按照GCP規范和相應研究指南進行的。
梅斯醫學開發針對上市后研究的精簡且經濟有效的標準操作規程,最大限度地收集數據、監控和質量,同時最大限度地減少操作風險。
梅斯醫學真實世界研究團隊具有深厚的政策和專業知識,包括倫理和監管要求、患者隱私立法、調查人員補助政策、學術和網站網絡、患者協會、國家衛生數據庫和本地衛生保健系統
真實世界研究
真實世界證據的增長需求
梅斯醫學的藥物安全和藥物警戒團隊支持藥械的臨床試驗和上市后安全監查,為我們客戶提供產品整個生命周期內獨立和整體服務。
讓我們與眾不同的是我們的員工:高素質的藥物安全科學家和熟練的醫療專業人員,他們在患者管理,特定的藥物警戒服務以及監管法規方面,擁有深厚的專業知識和藥物安全管理豐富的經驗。

我們可以協助您:
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描繪自然病史和病程(例如,發病率,患病率,護理標準)
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通過描述疾病負擔來確定未滿足的臨床和人文需求
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收集罕見疾病人群數據
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量化真實世界產品特定和/或比較安全性,有效性,依從性和其他結局
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評估特定的治療模式,量化相關的護理成本,并填充衛生經濟模型
深入的數據洞察力
我們專注于您的研究問題,并提供包含各種實際數據源和數據的最佳解決方案。我們由健康經濟學家,流行病學家,生物統計學家和臨床醫生組成的綜合團隊對可用的數據庫進行嚴格評估,以確定那些能夠提供最佳信息以滿足您的研究需求的數據庫。我們對來自20多個國家(包括北美和歐洲)以及其他地區(如巴西,日本,韓國,中國,澳大利亞,臺灣)的數據來源有深入的了解和經驗。我們了解并可以分析大型索賠數據庫和電子病歷以及這些和其他數據源的組合。
我們專注于您的研究問題,并提供包含各種實際數據源和數據的最佳解決方案。我們由健康經濟學家,流行病學家,生物統計學家和臨床醫生組成的綜合團隊對可用的數據庫進行嚴格評估,以確定那些能夠提供最佳信息以滿足您的研究需求的數據庫。我們對來自20多個國家(包括北美和歐洲)以及其他地區(如巴西,日本,韓國,中國,澳大利亞,臺灣)的數據來源有深入的了解和經驗。我們了解并可以分析大型索賠數據庫和電子病歷以及這些和其他數據源的組合。
與專業機構、協會、學會、Kols的深入合作
實現最佳市場準入和有效商業化需要定制化的研究設計,深入的專業知識以及對全國Kols的關系網絡。我們對上市后環境的理解加上十數年臨床研究的經驗,轉化為獨有的能力,可提供量身定制的有效研究設計,以滿足特定目標和市場需求和產品的監管要求。此外,我們的運營模式是根據醫療,臨床,項目管理,監管,醫保和流行病學職能部門的專家意見量身定制的,以滿足項目特定目標和利益相關者的期望。

卓越的研究設計和執行
- 豐富的經驗 - 專注于真實世界研究設計、運營、監察和成果團隊,15個重點臨床研究領域,200多個合作研究點,500多位長期合作研究者,7萬多主任醫師會員,200萬臨床醫師資源
- 專業的研究團隊 - 在早期參與合作模式下工作時,在研究啟動和患者招募時間方面大大優于行業基準
- 治療領域專家 - 具有廣泛適應癥的能力,以及利用我們的臨床醫生和全國運營專業人員網絡的能力
- 通過技術和合作創新 - 充分利用人工智能和大數據技術,以及真實世界研究的特點,大幅降低研究成本,提高操作的效率,確保高質量的研究成果
真實世界數據
Effective communication of evidence and information is essential to conveying the value of your products, both to internal and external stakeholders. With approximately 20 years of experience, our highly trained staff provide medical writing services for the peri- and post-approval phases of the product lifecycle, guaranteeing a consistency in quality and voice. Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully compliant with regulations, industry best practices, and your corporate guidance.
- Real-world data collection
- patient or physician surveys
- Hybrid database studies
- Product Registries
- Disease Registries
- Electronic clinical outcome assessment eCOA (ePRO/eClniRO/eObsRO)