Genelife Clinical Research Pvt. Ltd.

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✨ Happy Deepawali from Genelife Clinical Research Pvt. Ltd.! ✨ As we celebrate the Festival of Lights, may this Deepawali bring new hopes, brighter days, and endless prosperity to each of you. At Genelife, we are grateful for the support and trust of our clients, partners, and dedicated team members who illuminate our journey in clinical research every day. Let’s continue to light the way for advancements in healthcare and a healthier future for all. Wishing you a Deepawali filled with joy, peace, and abundance. 🌟 Happy Deepawali! 🪔 #Genelife #clinicalresearch #happydiwali

#genelife #clinicalresearch #drugdevelopment #clinicaltrials #regulatory #preclinical #medicaldevices #medicaldevice #herbalmedicine #pharmaceuticals #CRO #Cosmetics #clinicalTrial #humantrial #preclinicalreserch #biotechnology #biosimilars #datamanagement #invitrodiagnostics #IVD #Validation #clinicalvalidation #Analyticalvalidan #GLP #GCP

World Lung Day 2024: Breathe Easy, Live Healthy At Genelife Clinical Research, we are committed to advancing lung health through innovation, research, and care. On this World Lung Day, we join the global community to raise awareness about the importance of healthy lungs and the impact of lung diseases on millions of lives. Lung health is crucial for overall well-being, yet conditions like asthma, COPD, and lung cancer continue to challenge healthcare systems worldwide. This day is a reminder to take proactive steps—quit smoking, reduce air pollution, and support early diagnosis and treatment through clinical research. Together, we can make a difference. Let’s prioritize lung health and work towards a future where everyone can breathe easier. #WorldLungDay #LungHealth #ClinicalResearch #BreatheEasy #HealthyLiving #GenelifeClinicalResearch

#genelife #clinicalresearch #drugdevelopment #clinicaltrials #regulatory #preclinical #medicaldevices #medicaldevice #herbalmedicine #pharmaceuticals #CRO #Cosmetics #clinicalTrial #humantrial #preclinicalreserch #biotechnology #biosimilars #datamanagement #invitrodiagnostics #IVD #Validation #clinicalvalidation #Analyticalvalidan #GLP

The MOHFW has notified the amendment to the NDCT Rules requiring mandatory registration of CRO for conducting the clinical trial or BA or BE study. These rules will come into effect from 1st April 2025. These rules provide the definition of the CRO, requirements for the registration of CRO, application process and issue of certificate of registration etc. CRO distinguishes from that of a sponsor.

The major differences between the ICH-GCP guidelines and the draft GCP proposed by the CDSCO involve several substantial updates aimed at modernizing and enhancing clinical research practices in India: 1. The draft guidelines emphasize incorporating advanced digital health technologies, such as wearables and sensors, into clinical trials to improve data collection and research methodologies. This reflects a shift towards more tech-savvy approaches in data acquisition, which includes both electronic and paper tools. 2. There are new definitions for concepts such as e-consent and decentralized clinical trials. The draft also introduces a focus on computerized systems validation, ensuring that these systems adhere to specified standards for data management and security controls. 3. The proposed changes update guidelines on ethics, emphasizing conflicts of interest, compensation for research-related harm, and privacy concerns. Quality assurance sections retain much of their previous content but incorporate a risk-based approach to quality management. 4. The draft guidelines also expand to cover newer areas of research like medical devices, stem cells, and nanoparticles, and include sections on academic clinical research, marginalized communities, and enhanced sponsor oversight and monitoring. These updates indicate a significant effort by CDSCO to align more closely with global standards while addressing the specific local needs. #genelife #clinicalresearch #drugdevelopment #clinicaltrials #regulatory #medicaldevices #medicaldevice #herbalmedicine #pharmaceuticals #CRO #Cosmetics #clinicalTrial #preclinicalreserch #biotechnology #biosimilars #datamanagement #gcp

#genelife #clinicalresearch #drugdevelopment #clinicaltrials #regulatory #preclinical #medicaldevices #medicaldevice #herbalmedicine #pharmaceuticals #CRO #Cosmetics #clinicalTrial #humantrial #preclinicalreserch #biotechnology #biosimilars #datamanagement #invitrodiagnostics #IVD #Validation #clinicalvalidation #Analyticalvalidan #GLP

At Genelife Clinical Research, we are dedicated to improving global health outcomes by addressing critical medical challenges. Sepsis, a life-threatening response to infection, claims millions of lives each year, and its impact can be devastating. It's imperative to recognize the early signs of sepsis and ensure timely medical intervention. Join Genelife Clinical Research Pvt. Ltd. in this crucial health initiative. Together, we can safeguard lives and reduce the global burden of sepsis. Let’s spread the word and ensure that both the public and healthcare professionals are equipped with the knowledge to respond swiftly to this medical emergency. #SepsisAwareness #GlobalHealth #ClinicalResearch #SaveLives #Genelife #ClinicalResearch #clinicaltrials #worldsepsisday

#genelife #clinicalresearch #drugdevelopment #clinicaltrials #regulatory #preclinical #medicaldevices #medicaldevice #herbalmedicine #pharmaceuticals #CRO #Cosmetics #clinicalTrial #humantrial #preclinicalreserch #biotechnology #biosimilars #datamanagement #invitrodiagnostics #IVD #Validation #clinicalvalidation #Analyticalvalidan #GLP