In their latest paper, just published in DIA TIRS, ACRO's #RBQM Working Group provides a real-world use case of how organizations can implement centralized monitoring and significantly reduce the need for 100% SDR/SDV. The report utilizes a clinical trial from clinicaltrials.gov to walk through a tangible, concrete example of centralized monitoring implementation. Read the full paper:?https://lnkd.in/e8ms3WQr
ACRO
制药业
Washington，District of Columbia 12,107 位关注者
Representing the Global Clinical Research Industry
关于我们
ACRO advocates as the collective voice of innovative clinical research and technology organizations to regulators and policymakers, educating stakeholders and shaping policies that foster efficient, effective, and safe conduct of clinical research. Since our founding in 2002, ACRO has been committed to strengthening public understanding and confidence in clinical research. ACRO’s membership has evolved from being comprised entirely of global CROs to now including several of the industry’s technology partners. ACRO looks to demonstrate the important contribution that CROs and technology companies make as partners in the development of new medicines and new treatments. The association is a leading voice for safe and ethical clinical trials, working with stakeholders globally to explore new paradigms for research and development and to promote a more innovative, safe, and efficient clinical trial process. As an association, we are especially interested in areas such as the expansion of the adoption of DCTs, RBQM, diversity and inclusion in clinical trials, enhancing the efficiency of R&D, data sharing, data protection and privacy, technology innovation, real-world evidence, patient-centered drug development, safety and ethics in clinical research, tax policies that support research and innovation, and a host of global regulatory issues.
- 网站
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https://acrohealth.org/
ACRO的外部链接
- 所属行业
- 制药业
- 规模
- 2-10 人
- 总部
- Washington，District of Columbia
- 类型
- 私人持股
- 创立
- 2002
- 领域
- Clinical Research、Clinical Trials、CRO、Biomedical Research和health
地点
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主要
获取路线
601 New Jersey Ave NW
Suite 350
US，District of Columbia，Washington，20001
ACRO员工
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Karen Noonan
Senior Vice President of Global Regulatory Policy at Association of Clinical Research Organizations (ACRO)
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Lisa Moneymaker
Medidata | Advisory Board - SGM Alliance | Board Member - ACRO | Board Member - ACDM |
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Sara Sabatino
Independent Business Owner at Sara Sabatino Consulting
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Sinan B. Sarac (MD, MSc, PhD)
Senior Vice President - Head, Regulatory Strategy Europe, Parexel.
动态
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??? The latest episode of ACRO’s Good Clinical Podcast explores the future of clinical research, from increasing accessibility and standardization to evolving site relationships and improving data quality through more representative trials. Listen today:
In this NEW special episode, ACRO Chair Jim Reilly of Veeva Systems and Vice-Chair Cassandra Kennedy of Fortrea joined ACRO's Good Clinical Podcast to discuss the current state of the clinical research ecosystem and where our industry should focus attention to continue moving research forward in 2025! Listen now: https://lnkd.in/gdMz_agR
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A #ClinicalTrial organization's audit trail review (ATR) process needs to be modern and reliable, says Medidata Solutions. Read more about the purpose of this procedure, its regulatory requirements, how generative #AI can help, and more: https://bit.ly/41zCxuw
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While geopolitical instability, economic pressures, and talent shortages continue to present challenges in the #ClinicalTrial industry, there is also tremendous opportunity and optimism. Jenny Denney, MBA, PMP of Parexel speaks to how evolving our current outsourcing model and strategies will be key to achieving greatness in this rapidly changing landscape. https://bit.ly/4iTAHLS
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“Every single study repeated that basic site training and the qualifications of participating in a clinical trial. And it was very time consuming for every single member of staff, regardless of how many trials they had done in the past…As an industry we were able to sit down, take a look at the standardizing of some training, and have more mutually accepted site qualifications and the reciprocity of acceptance of site GCP training.” On this special episode of ACRO’s Good Clinical Podcast, ACRO 2025 Vice-Chair Cassandra Kennedy of Fortrea joined Jim Reilly of Veeva Systems for a conversation on where our industry should focus its efforts in the coming year, including how standardization can make research more efficient and effective. Listen to the full episode now: https://lnkd.in/gdMz_agR
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Final FDA guidance on Decentralized Clinical Trials (DCTs) is here, and there are major positives to the approach, says Florence Healthcare Chief Clinical Trial Officer (and ACRO board member!) Catherine Gregor. Get a rundown of the recent guidance and how it addresses key operational pain points for both sites and sponsors as they navigate the DCT landscape: https://bit.ly/4eJdw5m
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How can a #ClinicalTrial team effectively navigate the changes that have come to research? Get insights from a legal expert in the field on political challenges, court rulings, funding policies, and more: https://lnkd.in/gKjGhA42
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A shoutout to ACRO's latest RBQM paper, "Risk-Based Quality Management: A Case for Centralized Monitoring," in a new article from Clinical Tech Leader. Read the full article: https://lnkd.in/eWKwwCiZ
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#AI is now being woven into the entire lifecycle of a #ClinicalTrial, not just discovery processes, says a Fortrea technology executive. Learn more about the tool's power to improve patient outcomes and increase diversity: https://lnkd.in/gVg_gUsR
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The European Health Data Space (EHDS) was developed "to create a single digital health data infrastructure across the EU and beyond," explains IQVIA. Dive into one aspect: enabling the re-use of health data for research, innovation, policy, and more: https://lnkd.in/gefKTWTT