Ensuring Safety in Clinical Trials: Key Takeaways from FDA Guidelines The FDA has recently reinforced its commitment to the safety of participants in clinical trials through comprehensive guidelines on safety monitoring. Here are some critical points to consider: Proactive Risk Management: Identifying potential risks early and developing mitigation strategies is paramount. This includes rigorous pre-trial assessments and continuous monitoring throughout the trial. Data Monitoring Committees (DMCs): Establishing independent DMCs ensures unbiased safety evaluations. These committees play a crucial role in reviewing adverse events and can recommend modifications or even halting the trial if necessary. Real-Time Reporting: Utilizing advanced technology for real-time data collection and analysis allows for prompt identification and response to safety concerns, ensuring participant well-being. Participant Communication: Clear and transparent communication with trial participants about potential risks and ongoing safety measures fosters trust and compliance. Learn how DMC-HUB powered by DDM™ can help you align with new FDA safety requirements. https://lnkd.in/dynjz5Fs Read the entire report here: https://lnkd.in/dA7UMcER #ClinicalTrials #SafetyMonitoring #FDA #MedicalResearch #HealthcareInnovation
CIMS Global
Software Development
Somerset, New Jersey 351 followers
Reshaping the Future of Clinical Trials
About us
With over 16 years of industry experience, CIMS has pioneered the reshaping of clinical trials with novel technology streamlining and fast-tracking clinical trials creating pathways to life-saving therapies. We bridge the gap between visionary researchers and effective treatments with significant cost-savings, speed and reliable data with a powerful toolkit: Cutting-edge eClinical suite: Our intuitive platform simplifies data management, streamlines workflows, and fosters collaboration across research teams. Pioneering data technology: We harness the power of AI and machine learning to unlock hidden insights, optimize trial design, and make faster, data-driven decisions. Proprietary closed system: This integrated ecosystem connects every step of the trial, enabling real-time monitoring, proactive safety adjustments, and dynamic course correction. Our primary focus lies in creating novel tools that accelerate breakthroughs, enabling more drugs to reach the market faster, improving patient outcomes.
- Website
-
http://www.cims-global.com/
External link for CIMS Global
- Industry
- Software Development
- Company size
- 11-50 employees
- Headquarters
- Somerset, New Jersey
- Type
- Privately Held
- Founded
- 2004
- Specialties
- biostatistics, clinical trial design, dynamic data monitoring, dynamic trial design, eClinical, artificial intelligence, machine learning, and data management
Locations
-
Primary
285 Davidson Ave
305
Somerset, New Jersey 08873, US
Employees at CIMS Global
Updates
-
Happy Friday from the new CIMS Office! We're thrilled to share that we've upgraded to a larger space, providing us with more room to foster collaboration and accelerate innovation. #NewBeginnings #InnovationHub
-
-
💡At CIMS, we believe that every team member, regardless of their role or tenure, holds the potential to drive our next big breakthrough. Whether it's a fresh perspective from a new hire or a seasoned insight from a long-time colleague, diversity of thought is our greatest asset. #Innovation #Teamwork
-
-
CIMS Global reposted this
Good experience at PharmaSUG 2024 and new connections and friends. See you next year! #PharmaSUG2024
-
-
Today, on World Clinical Trials Day, we at CIMS Global proudly acknowledge the incredible contributions of researchers, healthcare professionals, sites and participants who drive innovation and progress in medical science. #CTD2024 #clinicaltrials #clinicaltrialsday
-
-
The Power of Data in Medical Innovation The recent four-year study on Sotyktu (deucravacitinib) for moderate-to-severe plaque psoriasis showcases the transformative potential of comprehensive data analysis. Consistent safety and durable response rates underline its efficacy, highlighting the importance of long-term data in advancing treatment options. At CIMS, we leverage revolutionary tools to harness robust data, driving forward innovations that enhance patient care and outcomes. Let's continue to unlock the full potential of data for a healthier future. #DataDriven #MedicalInnovation #CIMS #HealthcareTransformation #clinicaltrials
-
We are excited to feature Xiaoliu Xu, our Clinical Data Scientist II, as our CIMS Spotlight of the month! She is a highly valuable member of our team and we are very grateful to have her. Xiaoliu (Sue) Xu
-
-
🌍 This Earth Day, Let's Embrace Paper Saving in Clinical Trials with eBinder! https://lnkd.in/e6fX2cEr eBinder revolutionizes the way clinical trials are conducted by digitizing the entire process, from documentation to data processing. Here's why eBinder is a game-changer: 🌱 Paperless Operations: Say goodbye to mountains of paperwork! With eBinder, we eliminate the need for paper-based documents, reducing waste and transcription errors from manual data entry. 💡Innovative Technology: Built on cutting-edge technology, eBinder offers a secure and user-friendly platform converting scanned DCFs into digital format to EDC. 🔍 Efficient Document Management: eBinder streamlines document organization and retrieval, ensuring quick access to essential trial materials while minimizing administrative overhead. 🌐 Remote Accessibility: Whether you're across the street or across the globe, eBinder provides seamless access to trial data, fostering collaboration among researchers and stakeholders. #EarthDay #PaperlessTrials #eBinder #ClinicalResearch
-