ClinFocus

The article highlights key lessons from FDA Form 483 observations in clinical trials, emphasizing the need for strong sponsor oversight, data integrity, and proactive site management. It discusses common regulatory pitfalls and strategies to enhance trial compliance, ensuring high-quality outcomes.

This article emphasizes how independent oversight ensures data integrity, protects participant safety, and meets regulatory requirements like ICH GCP and FDA standards. It underscores the value of a risk-based monitoring approach to identify issues early while allowing sponsors to maintain control without overextending their resources.

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Are you attending the #SCDM24 Annual Conference in Boston this September? Be sure to visit ClinFocus at Booth 617 to learn more about our clinical data science and cost-effective biometrics solutions. Discover how we transform clinical trial data into meaningful insights that drive success in limited timelines. We’re excited to connect with you and explore how our services can help meet your clinical development needs. ? We look forward to seeing you there! #SCDM2024 #ClinicalDataScience #ClinicalTrials #BiometricsSolutions #ClinicalDevelopment

The average size of data generated by a clinical trial patient is expected to increase significantly in the near future [1]?due to advancements in?precision medicine, the discovery of correlative biomarkers, and advanced diagnostics.?? For example, one study found that six drug/nutritional supplement trials generated around 137,008 data items for 126 participants [2]. This means each participant generated approximately 1,087 data items on average.? ? As a result, data science and analysis will continue to play a crucial role in complex clinical trials with multiple data sources, and innovative approaches are needed to maximize these advancements and improve patient outcomes.? ? To facilitate innovation in?data collection, our approach centers on enhanced integration of data from various sources including Electronic Health Records (EHRs), wearable devices,?eDiaries?and EDCs with real-time analytics and or predictive modeling. In combination with advances in AI, integration of various data sources provides deeper insights into primary and secondary endpoints.? ? Why It Matters:?Effective data science is essential for translating medical innovations into real-world benefits. By improving how we collect, handle and analyze data, we can?increase confidence in the analysis of clinical trial data. ?Sources:?? [1](https://lnkd.in/eqhrrkd5).? [2]https://lnkd.in/dqmKHUnR).? ? #OncologyInnovation #DataManagement #PrecisionMedicine #ClinFocus #EHR #Biometrics #HealthcareInnovation #ClinicalTrials #AIinHealthcare

ClinFocus Advancing Public Health through Early Cancer Detection As part of our commitment to #CorporateSocialResponsibility, ClinFocus is championing public health in Lagos State today, 20th July 2024, by providing free prostate and Breast cancer screenings which play a vital role in successful treatment and management. Breast cancer is the most common cancer among women globally, accounting for 25% of all cancer cases. The screening program offers accessible mammograms and clinical breast examinations to detect abnormalities early, which can increase the 5-year survival rate to nearly 90%. Prostate cancer is the second most common cancer in men worldwide, with over 1.4 million new cases diagnosed annually, according to the Global Cancer Observatory. Offering free PSA tests and digital rectal examinations, ClinFocus enables early detection, which significantly improves treatment outcomes and survival rates. Our collaboration with the Foundation for Cancer Care enhances our ability to provide these crucial services. This partnership enables us to offer comprehensive screenings and educational programs that emphasize the importance of early detection. Through these efforts, we aim to gain insights, raise awareness, and develop analytics that can be used to track cancer burden across various populations. #PublicHealth #CancerAwareness #EarlyDetection #BreastCancer #ProstateCancer #LagosState #Healthcare #CancerPrevention #CommunityHealth #ClinFocus

The positive outcomes and innovative potential that arise from the collaborative efforts of specialized CROs #ClinFocus #ClinicalTrials #CollaborationInResearch #InnovationInClinicalTrials #BiometricsServiceProvider?

At?ClinFocus, we're at the forefront of revolutionizing clinical research through our unparalleled expertise in EDC Development, Clinical Programming, and Biostatistics. Our capabilities empower pharmaceutical, biotech, and medical device companies to bring life-changing therapies to patients faster and more efficiently than ever before. ?? EDC Development: We specialize in developing cutting-edge Electronic Data Capture (EDC) systems tailored to meet the unique needs of each study. From user-friendly interfaces to robust data security measures, our EDC solutions streamline data collection and management, ensuring accuracy and compliance throughout the clinical trial process. ??? Clinical Programming: Our team of skilled clinical programmers transforms raw data into actionable insights, driving informed decision-making for our clients. Whether it's developing customized reports, implementing data visualization tools, or optimizing database performance, we leverage the latest technologies and best practices to deliver exceptional results. ? ?? Biostatistics: With expertise in biostatistical analysis and modeling, we provide invaluable support in study design, sample size determination, and statistical analysis planning. Our biostatisticians employ advanced methodologies to analyze complex clinical data, helping clients derive meaningful conclusions and drive evidence-based decision-making. Partner with?ClinFocus?and gain a competitive edge in the dynamic landscape of clinical research. Together, let's accelerate innovation and transform lives. Reach out?to [email protected] to learn more about our comprehensive suite of services and how we can tailor solutions to meet your specific needs.? ? #ClinicalResearch #EDCDevelopment #ClinicalProgramming #Biostatistics #Innovation #Healthcare #Pharmaceuticals #Biotech #MedicalDevices"?

ClinFocus is proud to announce, we are now ISO 9001:2015 certified! ? ClinFocus is pleased to announce that it has achieved ISO 9001:2015 certification, an internationally recognized standard that ensures a quality management system within the company. After thorough preparation and auditing, the company was able to attain this height. This certification demonstrates ClinFocus's commitment to quality and increasing client confidence. ? What is ISO 9001:2015? The ISO 9001:2015 certification issued by the International Standard Organization is a tool that helps businesses enhance their performance across different sectors and sizes. It enables them to meet customer expectations and prove their dedication to quality. The certification outlines the requirements for establishing, implementing, maintaining, and continuously improving a quality management system. What does this certification mean to us? This demonstrates our commitment and capability to deliver quality. During the certification process, we identified and eliminated inefficiencies, streamlined operations, and promoted informed decision-making. ? About ClinFocus We are a global team of dedicated professionals driven by a shared passion for scientific excellence. Our primary objective is to deliver top-tier clinical biometric services and leadership throughout your clinical trial journey. We are dedicated to extracting meaningful insights from clinical trial data www.clinfocus.com.