Binoy Varghese

An Integrated Data Review Plan streamlines the clinical trial process by eliminating redundant data reviews, establishing clear quality objectives, and minimizing the overall burden of data review. #clinical #clinicaltrials #clinicalresearch #biometrics #statistician #data #healthcare #rbqm #rbm #innovation #sasprogrammers

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Key Differences b/w Randomized Clinical Trial (RCT) vs RWE (Real-World Evidence): Learn more about Real World Data: https://lnkd.in/gRGZdJJM Reference: https://lnkd.in/gN2vf6Hp #clinicaltrials #clinicareserach #data #healthcare #innovation #patient #regulatory #india #rct #rwe

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During this webinar I’ll share my reflections on our journey to leverage AI to accelerate clinical trials. We’ve made significant investments and progress- and I look forward to sharing our success and lessons learned.

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🌍 Everyone deserves a chance at a healthy life. But who you are, where you were born, or how much you earn, can determine how healthy you are. 💻 Data and health technologies like AI are powerful tools that can help address inequities by identifying communities that need better care, guiding healthcare resources toward them, and improving the quality of care received. 🤝 Partnerships play a pivotal role in bringing the skills and resources of the public and private sectors together to work with communities. To hear more, watch the video from our Head of Global Policy, Advocacy and Health Equity, Stefan Weber. #WHS2024 #HealthEquity #Interconnectedhealth

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I recently had a great conversation with our CEO Rama Kondru, Ph.D., where he shared one of his favourite lines "I am happy, but I am not satisfied."   At first, it sounds simple, but when you really think about it, it holds incredible value for both personal and organizational growth. Happiness and satisfaction, two words that often seem synonymous but are quite different in practice.   Being happy means appreciating where you are. I am happy because I appreciate the progress I have made, the opportunities I have had, and the relationships I have built along the way But not being satisfied is what drives you to push boundaries, innovate, and keep evolving. It’s this balance that fuels progress and keeps us striving for more. There is always more to learn, more to achieve, and more ways to improve. It is a healthy hunger to stretch beyond comfort zones and pursue new goals.   This perspective is so important for continuous growth and development—both as individuals and as a company. Emmes Emmes Group Veridix AI, part of Emmes Group   #GrowthMindset #ContinuousImprovement #Leadership #PersonalDevelopment #AmbitionAndGratitude

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Here's how we're solving the affordability gap of cancer care in India, and soon, in other developing countries - see our article in PLOS Digital Health

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ALCOA+ is an acronym used in pharmaceuticals, biotechnology, and the healthcare industry to ensure data integrity. It serves as a framework for evaluating and maintaining the reliability of data, in regulated environments. The details are below ALCOA: 1. Attributable: Data must clearly identify the person or system that created or modified it. 2. Legible: Data should be easily readable and understandable. 3. Contemporaneous: Data should be recorded at the time the activity or event occurs. 4. Original: The data should be in its original form or a verified copy. 5. Accurate: Data must be correct, truthful, and precise. ALCOA+ (enhancements to the core ALCOA principles): 1. Complete: Data must include all required information, without omissions. 2. Consistent: Data should be recorded in a logical, sequential manner. 3. Enduring: Data should remain intact and accessible for its entire retention period. 4. Available: Data must be readily retrievable whenever required. Additional ALCOA++ Elements: Traceable: Data must have a clear audit trail, showing all modifications and the person responsible for each change. This framework is critical for ensuring compliance with regulatory requirements such as those of the FDA or EMA, particularly in contexts like Good Manufacturing Practices (GMP).

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This is a very insightful blog by Katrina Rice!

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For an organization to grow and prosper, it needs to have a strong vision. This vision should articulate a clear picture of a realistic, desirable, and positive future state. Remember, for a large organization that seeks to be loved by its customers, it is vital that its employees love it first. #leadership #vision #culture #growth #customers #employees

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Developing Clinical Analytics Solution? Understanding Role-Specific Challenges to Drive Analytics and Technology Solutions! Identifying and addressing the pain points of individuals involved in clinical trials is paramount to the development of effective analytics solutions and technology platforms. By understanding the unique challenges faced by each role, we can create tools that streamline processes, improve efficiency, and enhance decision-making. CuMinds Innovations #clinicaltrials #clinicaldatamanagement #clinicalresearch #data #biometrics #innovation #technology #healthcare #patient

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RBQM Silence: Every Speaks, less Follows- Why or Why not? Key Factors! #clinicaltrials #clinicalresearch #rbqm #rbm #data #innovation #healthcare #data #biometrics CuMinds Innovations

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Lesson Learned from a oncology DCT trial: Reference: https://lnkd.in/gyF9U-RZ Challenges in DCT Implementation Technological Integration: Lack of integration between DCT platforms and hospital systems can hinder trial conduct and increase operational complexity. Patient Referral and Management: Clear delineation of responsibilities between investigators and treating physicians, as well as effective communication with patients, is crucial for successful patient referral and management in DCTs. Recruitment Strategies: While digital recruitment holds potential, the TELEPIK trial's reliance on traditional methods limited the evaluation of its impact on enrollment rates. Lessons Learned from TELEPIK DCT Potential: DCTs offer advantages in participant representation, data collection efficiency, and reduced patient burden. Optimization Needed: Despite these benefits, the early termination of TELEPIK highlights the need for refined DCT design and execution methodologies. Knowledge Gap: Limited evidence on DCT performance compared to traditional trials necessitates further research to inform future trials. Recommendations Comprehensive Evaluation: Conduct thorough post-trial analyses to identify critical factors influencing DCT success or failure. Technological Advancements: Prioritize the development of integrated technological solutions to streamline DCT operations. Collaborative Approach: Foster collaboration between sponsors, investigators, and healthcare providers to address challenges and optimize DCT design. Patient-Centric Focus: Continuously evaluate DCTs from the patient perspective to ensure positive experiences and enhance patient engagement. Rigorous Evaluation: Conduct comparative studies to assess the effectiveness of DCTs versus traditional trials in terms of recruitment, retention, and cost. #clinicaltrial #clinicalresearch #data #healthcare #patient #dct

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Utilizing Data Analytics to Enhance Patient Outcomes Data analytics holds tremendous potential to revolutionize patient outcomes in the healthcare industry. By harnessing the power of data, we can derive crucial insights that lead to better decision-making and improved patient care. Through the use of advanced data models and analytics, we can identify trends, predict patient needs, and optimize treatment plans. This improves the efficiency of healthcare delivery and ensures that patients receive the most effective care tailored to their unique needs. One of the industry's key challenges is integrating diverse data sources while upholding strict privacy and security standards. However, the rewards of overcoming these challenges are substantial. Improved patient outcomes, reduced costs, and a more proactive approach to healthcare are just a few of the benefits. As we continue to innovate and enhance analytics capabilities, the future of healthcare looks promising, with data playing a pivotal role in shaping it. How is your organization utilizing data analytics to improve patient outcomes? #DataAnalytics #PatientOutcomes #HealthcareInnovation

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🌟 Exciting Initiative from the FDA! 🌟 The FDA's latest efforts to streamline drug development and improve patient access to innovative medicines are truly transformative! This initiative, led by the FDA's Center of Excellence, focuses on enhancing the efficiency of drug development processes, ensuring faster and more equitable access to life-saving treatments for patients in need. Whether you're in the pharmaceutical industry, healthcare, or regulatory affairs, these changes signal an important shift toward a more patient-centric future. It's crucial that we stay informed and engaged as the FDA continues to implement these improvements. #DrugDevelopment #PatientAccess #FDA #InnovationInMedicine #HealthcareExcellence #RegulatoryAffairs Compliance Architects®

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What better PODD: Partnership Opportunities in Drug Delivery Community News #PODD2024 grand finale – than a discussion on #OralPeptides #OralBiologics with experts Andy Lewis, Suman Luthra, Lipa Shah? We covered #design, #drugdelivery and #formulation aspects of this aspirational #research and #development aim. Key take home messages include 1) Barriers are monumental – degradation by peptidases and permeability needs to be overcome by design but delivery can also help with permeability, 2) design strategies includes non-natural amino acids, conjugation, cyclization, stapling, prodrugs – important here to also consider the clinical substance supplies as the more elaborate designs increase complexity, 3) thinking outside the small intestine important – buccal, gastric and colonic delivery have shown success, 4) physicochemical and biophysical property elucidation really important for a preclinical and clinical formulation strategy that includes excipient selection such as permeation enhancers, 5) #biopharmaceutics knowledge extremely valuable – know where you want your peptide to be absorbed and design the product accordingly, 6) in terms of clinical POC, preclinical to clinical translation can be achieved if you know your biopharmaceutics well and tweak the formulation accordingly, 6) blue sky is the ingestible injectables devices, designing novel permeation enhancers and targeting transporters (although the latter has been attempted for a while wo being hugely successful) Thanks to the organizers and PODD staff for an awesome conference!

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