CRO Oversight
治験依頼者にとって、Study Startupのoversightを改善することは、CROパートナーにアウトソーシングされた試験の進捗状況をリアルタイムで可視化し、戦術的なプロジェクト指向の関係から戦略的なパートナーシップへと発展することを意味します。
Oracle Analyze Insight for Activate Cloud Serviceインテリジェンスは、CROパートナーにアウトソーシングされた試験のタイムリーなステータス更新と業務上のインサイトを得ることにより、CROとの透明性、コミュニケーション、およびコラボレーションを改善し、パフォーマンスとガバナンスの強化につながります。また、豊富な分析、ダッシュボードを通じて、チームを待ちのプロセスから攻めのプロセスへと移行するのを支援します。
Analyze Insight for Activate Cloud Serviceの利点
- すべての試験とCROパートナー間でパフォーマンス指標を標準化
- サイクルタイム指標による複数のCROに委託した複数の試験のリアルタイム評価
- CROパートナーのパフォーマンスを定量化し、外部委託試験のガバナンスを改善
- 非生産的な活動に浪費される時間をカットすることで業務効率を向上し、透明性の高い戦略的パートナーシップを促進
- 試験の多角的知識を構築し、将来の試験の積極的なプランニングを支援
Study Startup Webcasts
U-Turn or Norm? #NoGoingBack and Decentralized Trials in a post-COVID-19 World
Will the industry embrace this change or revert back to its old ways post-COVID-19?
Vendor Oversight: Ensuring Compliance by Assessing Study Risks
Learn how vendor oversight can be implemented end-to-end, ensuring compliance with ICH regulation guidelines.
Is Artificial Intelligence Critical to Improving Efficiencies and Outcomes in Clinical Trials?
Learn how to gain critical operational insights by using AI/machine learning to transition from subjective decision making.
COVID-19's Impact on the Digital Transformation of Clinical Trials
Learn how digital transformation roadmaps were accelerated to embrace innovative approaches to overcome adversary.
Are the Intended Benefits of ICH Regulations Obscured by the Adoption Struggle?
Learn how fundamental to new ICH guidelines is the modernization of processes and technology with a focus on QbD and risk-based management approaches.
Using Artificial Intelligence to Improve Clinical Trial Efficiency and Optimization
Learn how machine learning technologies can help predict outcomes in clinical trials, leading to faster drug approval times and lower costs.
Outsourcing to CROs: Expediting Clinical Operations or Oversight Nightmare?
Learn how to overcome the complexities introduced in outsourced studies (e.g., quality, oversight, collaboration, and governance).
Dismantling Data Silos to Improve Study Startup and Mitigate Risk
Learn how entrenched silos have stymied data flow efforts due to minimal understanding of what is needed downstream.
Avoid Rescue Studies, Reduce Costs and Timelines, and Accelerate Clinical Operations with Metrics
Drive competitive performance and operational excellence by focusing on bottlenecks and processes ripe for optimization.
Ensuring Quality and Risk Mitigation with Proactive Planning in Clinical Trials
Learn how good clinical practice (GCP) guidelines and systems help improve overall study quality.
The Importance of Contemporariness and an Approach to Mitigate Audit Findings
Learn how contemporariness can be defined in operational SOPs and implemented in daily operations to ensure audit readiness.
Standardization Drives Transparency and Optimization in Clinical Trial Startup
Learn how to tackle the challenge of improving budget and contract cycle times in starting clinical trials.
News and Resources
臨床試験は、技術の進歩、業界の取り組み、規制およびプロセスの変化とともに絶えず進化しています。以下の記事で最新の情報についてご覧いただけます。
What's New in Study Startup
Business Briefs
- Don't Settle for Less: Redefining the Core and Scope of Study Startup
- Analytics and Metrics Help Pinpoint Costs of Study Startup (PDF)
- Breathing Life into SOPs with an Automated Workflow-Driven Process
- Moving Beyond Excel to Purpose-Built Applications for Speedier Study Startup
- Building Risk Assessment and Mitigation into Study Startup
- Study Startup Solutions Improve CRO Oversight Through Collaboration
- Study Startup: New Battleground in CRO Differentiation Strategy
- Spotlight on Quality in Study Startup (PDF)
Research Reports
- Perceptions and use of decentralized clinical trials (PDF)
- Artificial intelligence and machine learning survey report (PDF)
- ChromoReport Spring 2020 - Importance of Leading Indicators to Machine Learning Predictive Models (PDF)
- ChromoReport Winter 2019 - Proactive Planning with Predictive Analytics (PDF)
- ChromoReport Fall 2019 - Performance of Multi-Country vs. Single Country Studies (PDF)
- Impact Assessment of eClinical Technologies and Industry Initiatives on Sites (PDF)
- ChromoReport Summer 2019 - Utilizing a Risk-Based Approach to Contract Optimization (PDF)
- eClinical Technology Adoption and Challenges in Study Startup (PDF)
- Tufts CSDD START II Site Selection (PDF)
- Tufts CSDD Assessing Practices and Inefficiencies (PDF)
- Tufts CSDD START Study Initiation Cycle Times (PDF)