Delivering CRO Oversight
For sponsors, improving oversight of study startup means real-time visibility into the progress of studies outsourced to their CRO partners, and transitioning away from tactical projects toward strategic partnerships, with both stakeholders having a vested interest.
Oracle Analyze Insight for Activate Cloud Service intelligence improves transparency, communication, and collaboration with CROs by providing sponsors with timely status updates and operational insights into outsourced studies with their CRO partners, leading to enhanced performance and governance. Through visually rich analytics and dashboards, we help transition your team from a process that is reactive to one that is more proactive.
Analyze Insight for Activate Cloud Service Benefits
- Standardize performance metrics across all studies and CRO partners
- Enable real-time assessment of concurrent studies with multiple CROs by tracking cycle time metrics
- Improve governance of outsourced studies and quantify performance of CRO partners
- Encourage high transparency strategic partnerships and improve operational efficiency by eliminating time wasted on nonproductive activities
- Build institutional knowledge on study dimensions to aid in proactive planning of future studies
Study Startup Webcasts
How to avoid significant delays in multi-country studies due to EU 536/2014 clinical trial regulation
Learn the importance of this regulation and its impact on large multi-country studies.
Bringing patient centricity and scale to decentralized trials
Learn how decentralized clinical trials have forced the industry to rethink their approach to study startup and associated regulations.
Moving beyond 10 steps to clinical study startup
Learn how the traditional steps needed to start clinical trials need to be expanded upon, collapsed, and fit for purpose.
New EU (536/2014) clinical trial regulation set to attract more studies and innovation
The way clinical trials are conducted in the European Union will undergo a major change when this regulation comes into effect in January 2022, which is binding across all member states.
Are CROs prepared for ICH E6 (R3)?
As CROs fight to maintain market share and ensure long-term survival, those capable of critical thinking and proactive planning may be well-positioned to reap the rewards.
How will ICH E8 (R1) and E6 (R3) make clinical trials oversight more efficient?
Learn about forthcoming guidance which renews the focus on efficiencies in conducting clinical trials and provide tools to do so - significantly impacting oversight.
How can the accelerated availability of Pfizer-BioNTech's COVID-19 vaccine be replicated?
Learn how Pfizer successfully brought a highly effective and safe COVID-19 vaccine to market in under a year, and how these same breakthroughs could be applied to other studies.
How to build productive, strategic sponsor-CRO partnerships
Learn how trusted collaboration is key to keeping sponsor-CRO partnerships aligned on shared goals.
How to realize the efficiency benefits of ICH E6 (R3) before it's released
Learn how the focus on efficiency in ICH E6 (R3) will fundamentally change clinical trials.
How machine learning can help improve the operational efficiency of clinical trials
Learn how machine learning can help identify and rectify systemic inefficiencies, allowing life science organizations to learn and adapt.
Reducing Complexity in Starting Clinical Trials - More Patients, Faster Startup
Learn how the collaboration between Cognizant and Oracle eliminates redundancy for sites and deliver better outcomes from sponsors/CROs.
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.
News and Resources
Clinical trials are constantly evolving, with advancements in technology, industry initiatives, regulatory, and process changes. Gain perspective and learn more about these changes in the resources below.
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)