臨床モニタリング

Our dedicated Clinical Research Associates and CRAs and CMAs monitor studies worldwide. Each CRA focuses on a single therapy area, so they have deep knowledge of the patients, investigative sites and specific challenges involved. All Clinical Trial Monitoring team members receive ongoing training to ensure they are completely up-to-date with current legislation, techniques and technologies. They are supported by our innovative Global Clinical Operations Management (GCOM) and Central Monitoring groups. 

Thorough training and support are vital for CRAs at all levels. We provide training via the CTI, to ensure our CRAs are always up-to-date with new techniques and technologies, and familiar with any changes in legislature. Over time, our CRAs build a strong rapport with site staff and develop a deep understanding of the challenges sites face. 

Our Central Monitoring group supports sites and patients, overseeing the running of studies and directing strategy throughout the clinical trial process. The group acts as a bridge between the Site Start Up team and therapy area unit, playing a central role in developing and trialing new processes, and driving solutions around data-focused monitoring, as well as predicting any issues that may arise.

このGCOMグループを介したデータ解析により、SOP、ツール／システム、およびトレーニング要領の変更等の改善が必要な分野を特定して、プロセス改善、効率化、およびバリューアップを図り、高品質かつコンプライアンス遵守のデリバリーを実現します。

The GCOM also oversees the Global Resource Management (GRM) tool, which tracks staff assignments and allocations, providing direction around staffing needs. In addition, the GCOM represents the clinical perspective in corporate initiatives, such as strategic data monitoring and staff training.

FSPモデル

We offer our global clinical monitoring capabilities in either a full service or FSP model. Our Clinical FSP Monitoring Group engages a hands-on partnering approach that emphasizes collaboration and communication between the assigned CRAs, investigative sites, cross-functional teams, line management and customers. From site assessment and qualification to study close-out, our commitment to success starts with the first conversation.

サイネオス・ヘルスの敏捷性および柔軟性は、試験の特異性に対応するための重要な能力です。そうした能力を以って、弊社は実施医療機関と慎重にやり取りし、あらゆる側面に治療に関する豊富な経験を応用し、チームによる一貫したサービスおよびソリューションの提供を確保します。

個々の試験に特有の臨床的要件を重視する考え方によって、ガバナンスを適応し、ライン管理体制を発展させて、QA監督を強化します。

目に見える成果に相応しい人材、高い品質、およびオープンなコミュニケーションをお客様の方向性に一体化することで、患者さんフォーカスかつ有意義なアウトカムの取得に向かう実施医療機関のエンゲージメントへの道が開かれます。

事例研究

Background: We have partnered with a large global pharmaceutical company on their early development portfolio for the past five years. This partnership has expanded to incorporate small studies. As with all early development studies, quick start up and flexibility are paramount. Processes need to be more streamlined in the development and small study stages than in Phases II-IV.

Solution: We have developed tailored budget and delivery approaches in response to these unique needs. We have also created a dedicated core team with extensive experience in running smaller early phase health volunteer and patient studies in a broad range of therapeutic areas. 

このチームは、フルサービスによる試験管理と限定的サポートのいずれにも柔軟かつ迅速に対応することができます。

Results: By having a dedicated team, we are able to focus on ensuring the priority of small studies versus larger Phase III-IV studies, enabling flexible resourcing, including the ability to shift knowledgeable resources among studies at the sponsor’s request while maintaining quality. This allows for the sponsor to quickly and effectively substantiate go/no-go decisions, developing sponsor-specific processes and templates that all members of the team become experts on, and immediate Site Start Up. An award notice immediately triggers Project Management resource assignment, with Site Start Up and Clinical Monitoring resources typically aligned to the project within 1-2 weeks (depending on urgency).

この確立されたソリューションが、以下に帰結します。予算見積もりの効率および精度の向上；施設選定とIPリリースに係る承認取得に要する時間を削減；専任コアチームを擁することで複数試験間の業務の一貫性を維持；速やかな施行を促すため試験固有の作業指示テンプレートを作成；パートナーシップ内での作業量増加および地域の拡大

オープンなコミュニケーションと共通認識に基づく戦略的パートナーシップの視点から、お客様にテーラーメイドのソリューションを提供します。

戦略的パートナーシップの主な目標は、チームメンバーが真のパートナーとして、共通ゴールを目指して完全に一体化し、ベストプラクティスと教訓をフルに活かして、品質、イノベーション、および効率性を継続的に向上させることです。

ファンクショナルパートナーシップの確立、管理、発展における豊富な経験・実績に基づき、以下のような移行計画が、パートナーシップの成功を導くための必須要素であると考えます。

Planning. Understanding the customer’s trial monitoring organization, goals and objectives, as well as identifying key milestones to build the transition plan and ensure continued success.

上市. Three factors that are especially important to successful start up are the timing of the partnership launch meeting, which should be within two weeks of award, the setting of a timetable to review project pipelines, and re-establishing the objectives of the relationship in clear, direct terms that can be communicated to all team members.

Metrics. We want to ensure that quality and timeline metrics are well defined and understood by all partnership members. Both organizations need to be clear on timeline expectations, the responsibilities of each partner, and the definition of quality. Early agreement on key performance indicators (KPIs) will facilitate focused and productive discussions.

Governance Structures. This predefined structure creates escalation channels to resolve business and operational issues and ensure the proper communication of objectives consistently through both organizations.

Establish Communication Opportunities Between Core Teams. The quality of the relationships built within this partnership drives success. We recognize the importance of, and are committed to, establishing positive working relationships with the customer to promote honest, open dialogue and allow for the highest quality service delivery.

その結果、以下のような成功につながります。

• お客様の社内チームが弊社のFSPモデルを信頼する
• パートナーシップ内で共通の目標および成果に向かってシームレスに協働する
• KPIに応じたサービスの提供と、お客様のビジネス成果

We draft a formal Implementation plan, which we refine collaboratively with our customer in the initial stages of this partnership expansion kick-off. The plan addresses a comprehensive range of topics, including, but not limited to:

Management and Governance. Integrating our management team with yours, ensuring seamless communication, and promoting effective teamwork, including defining executive operations and project-level leadership groups, SLAs and KPIs, communications and meeting cadences, and drafting Executive and Operations Management Committee charters.

Resourcing. Forecasting needs and setting strategy, including:

• 予測の頻度および詳細を含む、人員配置レベルの見直しに関するプロセスの定義
• サイネオス・ヘルスへの移行範囲でのリソースの特定
• 移行がない場合のリスク軽減のため、プールする候補人材の特定
• 保持と統合の戦略

Operational Standards and Practices. This framework enables resources to work within the applicable SOPs and on the customer’s systems, including: 

• 運用計画書の概要案
• コミュニケーションツールおよび管理ツール
• マネジメントの実行責任者（Responsible）、説明責任者（Accountable）、協議先（Counsulted）、および報告先（Informed）（RACI）
• トレーニングおよびオンボーディング
• パフォーマンスおよびコンプライアンスのメトリクスの定義

Our SRG Monitoring Group engages a hands-on partnering approach that emphasizes collaboration and communication between the assigned CRAs, investigative sites, cross-functional teams, line management and customers. From site assessment and qualification to study close-out, our commitment to success starts with the first conversation.

サイネオス・ヘルスの敏捷性および柔軟性は、試験の特異性に対応するための重要な能力です。そうした能力を以って、弊社は実施医療機関と慎重にやり取りし、あらゆる側面に治療に関する豊富な経験を応用し、チームによる一貫したサービスおよびソリューションの提供を確保します。

個々の試験に特有の臨床的要件を重視する考え方によって、ガバナンスを適応し、ライン管理体制を発展させて、QA監督を強化します。

目に見える成果に相応しい人材、高い品質、およびオープンなコミュニケーションをお客様の方向性に一体化することで、患者さんフォーカスかつ有意義なアウトカムの取得に向かう実施医療機関のエンゲージメントへの道が開かれます。