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リスク評価・低減戦略(REMS)及び
リスク管理のためのコラボレーション

共有システムの開発、リスク評価・低減戦略(REMS)プログラムの開発、または複雑な複数スポンサープログラムの導入は、様々な課題があります。複数資産をカバーする1つの共有プログラムのデザイン、開発、実装、および管理のためにどのようにコラボレーションが必要でしょうか。

  • 50%

    50%の承認済共有REMS(リスク評価・低減対策)プログラムを私たちが管理

  • 2

    私たちが現在抱えている5案件のうち、以前は競合が行っていたものの、現在は私たちが管理している案件

  • 2

    FDA認可のために現在開発中の共有REMSプログラムで、我々がPMOとなっている案件

  • 1

    複数スポンサーの依頼による市販後調査件数

REMSおよびリスク管理について

 

私たちは、複数スポンサープログラムに関連する作業を管理する優秀なスタッフを擁しています。プログラムガバナンスおよびスポンサー管理、会議管理、文書管理、取引先の選定、パフォーマンスマネジメント、ならびに変更管理から予算編成および財務報告までのすべてに対応した一連のツール、プロセス、および手法を開発してきました。

私たちの使命はお客様のチームの負担を取り除くことです。最終的に、スポンサーに関連情報を分かり易い形でタイムリーに提供し、効果的な意思決定を支援します。複数スポンサーのエンゲージメントに対応したプログラム管理サービスを提供する枠組みを開発/運用しています。

お客様にご満足いただくために

一連の手法、ツール、およびプロセスには、以下の6つの要素が含まれています。

  • Governance Structure and Program Charter: Given the complexity of having multiple sponsors and vendors working together, we establish a robust governance framework and charter that articulates teams/committees, roles and responsibilities, and voting/approval processes (e.g., approving deliverables, program budget) to systematize the process of managing the program, which is critical when competitors are working together.
  • Team and Meeting Facilitation/Support: We provide everything that you would expect from a PMO (Program Management Organization) in support of team/meeting facilitation (e.g., invitations, agendas, meeting presentation materials, meeting minutes, action item identification, and tracking). We stand out from the crowd due to the sheer level of input and the scale of the solutions/recommendations we offer. We bring realistic solutions, and our deep strategic thinking behind those suggestions, to the table, which makes decision-making easier and more efficient for the sponsor representatives, who are often spread across multiple programs of the same nature.
  • Vendor Selection, Contracting and Oversight: A PMO for these types of programs must have best-in-class processes to identify, onboard and manage vendors. We have deployed our processes for well over 100 engagements, and most importantly, we have done so successfully on seven multi-sponsor REMS/PMR programs with numerous vendors. We have standardized processes and tools to support the RFP process, and we have worked to develop pre-populated requirements documents for many of the REMS elements that would apply to shared REMS programs. This allows for a fast start once we are prepared to secure vendors. The following are a few highlights of our capabilities in this area:
    • Clear understanding of contracting requirements needed in multi-sponsor REMS: We understand the needs for proper indemnifications and flow-down provisions for any PMO/sponsor agreement 
    • Active management of vendors: Our job as the PMO with regards to vendor oversight is to ensure a high-quality program that is cost-effective. We continuously monitor performance of vendors against requirements, scope and service-level agreements. Potential issues are actively monitored and reported to the sponsors. Additionally, we monitor the needs of vendors from a scope perspective on an ongoing basis to ensure the services contracted for are appropriate and cost-effective to meet the needs of the program
    • Proven back-office systems to manage financial aspects of vendor management: We have systems/processes that have already been deployed on similar projects to: 1) manage the collection of invoices from vendors; 2) provide single, consolidated and customized invoices to sponsors based on agreed-upon allocations, and 3) provide on-time payments to vendors.
  • Program Tracking and Reporting: We deploy a comprehensive set of reports, status memos and dashboards to enable clear, frequent and transparent communication of project milestones (completed and upcoming), sub-team updates, vendor performance, actual budget to planned, and decisions made. We understand that our customers need timely and accurate information packaged in a format that is robust and easy to understand. At the beginning of the project, we will review the proposed program reports and can customize and update the format based on our assessment of program needs and sponsor feedback.
  • Financial Management: Shared REMS/other complex programs are typically expensive, and sponsors require a clear understanding of the financial aspects of a program. We are skilled and experienced at managing the overall finances of the program and we provide robust, monthly reporting to sponsors.
  • Document Management: Program and potential regulatory events require program materials to be well-organized, accessible and secure. We develop a customized system, utilizing folder structure best practices from our experience, to administer a secure document management system, managing folders and access rights on an ongoing basis. 
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