Lalatendu Mishra

Implementing a robust QMS is crucial for any organization aiming to enhance customer satisfaction, streamline processes, and ensure continuous improvement. Pinnaxis QMS is not just about compliance; it's about fostering a culture of excellence and accountability. #QualityManagement #QMS #ContinuousImprovement #OperationalExcellence #pinnaxis #pharma #PV #pharmacovigilance #safetyquality

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The future of #pharmacovigilance is here! With advances in #RWD, #AI, and regulation, drug safety monitoring is reaching new heights. Discover how these factors are reshaping the #healthcare industry in our latest blog - https://ow.ly/m5L850UnpG5

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Till late 80’s and 90’s India used to produce 70-80% of pharmaceuticals raw material required by its pharmaceutical industry. Then came cheap Chinese API (Active pharmaceutical ingredient), due to incentives and modern technology by Chinese government. Slowly all small and medium companies died, since they cannot match the price. Till 2004-05 when pharma industry become fully dependent on these Chinese raw materials, they increase the price up to 5 times, covering earlier losses. Today India import 80-90% of API from China and they drive the prices. It will take decades for India to rebuild this manufacturing again. Similarly till 2020 Chinese EV market share in Europe was 1.9%, which in 2024 become 14.1%, again same strategy, cheap car with heavy subsidy from government, it’s not fair for European companies. We can clearly see the pattern. If it will not stop slowly they will kill this market as well, so I am happy at least EU union decided to go ahead with tariff implementation plan for Chinese EV.

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With 40 years of clinical innovation, @Dr. Reddy's Laboratories continues to lead in digital therapeutics and drug discovery by adopting a cloud and AI ready data strategy. 🩺✨ Under @Anish Agarwal, Sr. VP and Global Head of Data and Analytics, the multinational pharmaceutical company uses @Informatica Intelligent Data Management Cloud (IDMC) to automate data governance and improve quality across integration and engineering pipelines, resulting in: ✔️ 50% less data pipeline dev time ✔️ 5,000 records per second delivered for AI ✔️ >95% AI data quality benchmark Watch the video to see how Informatica is helping Dr. Reddy’s bring affordable therapies to market faster than ever: https://infa.media/4fp2nqz

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Are you an Pharma/API manufacturer looking to digitize your Sales and Service processes while getting the data insights to fuel growth? Our custom solution leveraging the salesforce platform allows you to better manage accounts, track inquiries, create seamless workflows with your QA teams, all powered by reports and dashboards. Reach out for information and we would love to get you started. #salesforce #sales #salescloud #analytics #crm Pavan Kumar Veeravalli Ranga Rao , M.Sc(Tech), DBA, PMP, CISA Asha Kallepu Ravali Gudep Mani Nag

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Streamline Your Clinical Trials with 𝗩𝗲𝗲𝘃𝗮 𝗩𝗮𝘂𝗹𝘁 𝗖𝗧𝗠𝗦! Tired of managing trials across multiple platforms? 𝗩𝗲𝗲𝘃𝗮 𝗩𝗮𝘂𝗹𝘁 CTMS simplifies the process Slide through the carousel to know more!! #RudhraInfoSolutions #RIS #Veeva #ClinicalTrialManagement #VeevaVaultCTMS #HealthcareInnovation #VeevaVault #TechSolutions #Innovation #LifeSciences

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Pharmaceutical companies are under constant pressure to balance innovation with strict compliance. In Express Pharma, Suresh Perikala, Senior Engineering Lead – DevOps and Cloud Engineering Practice at #Altimetrik, shares insights on how cloud provisioning can transform the industry by enhancing compliance, data security, and operational efficiency. Learn how technologies like Infrastructure as Code (IaC) and automation are enabling pharmaceutical companies to stay #agile and compliant. #Pharma #CloudProvisioning #Compliance #Innovation #DigitalBusiness Nayan Naidu Anuradha Natarajan Farid Roshan Swapnil Kahate Ramakanta Routaray

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🌐 𝐄𝐧𝐚𝐛𝐥𝐢𝐧𝐠 𝐒𝐞𝐚𝐦𝐥𝐞𝐬𝐬 𝐈𝐃𝐌𝐏 𝐃𝐚𝐭𝐚 𝐌𝐢𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧 In our latest success story, Celegence partnered with a global #pharmaceutical leader to streamline the migration and integration of critical IDMP data across multiple systems and markets! Here’s how we helped drive compliance and operational efficiency: ✅𝐃𝐚𝐭𝐚 𝐌𝐢𝐠𝐫𝐚𝐭𝐢𝐨𝐧: Ensured seamless transfer of structured product data to meet stringent #IDMP standards.  ✅𝐒𝐲𝐬𝐭𝐞𝐦 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: Unified diverse data sources to create a single, compliant system of record.  ✅𝐑𝐢𝐬𝐤 𝐌𝐢𝐭𝐢𝐠𝐚𝐭𝐢𝐨𝐧: Proactively identified and addressed compliance risks through comprehensive validation checks. 👉 Full Case Study Here: https://lnkd.in/gnDN8EJz With Celegence’s tailored #regulatory solutions and expertise, the company successfully migrated its data and achieved full IDMP compliance. 📧 Interested in streamlining your IDMP compliance efforts? Connect with us today to explore customized solutions: https://lnkd.in/g9bGxh6U #Pharma #RegulatoryCompliance #DataMigration #LifeSciences #RIMS #SuccessStory #Pharmaceuticals #RegulatoryAffairs #PharmaCompliance

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I am attending the SCDM India 2024 Pre-conference Workshop, 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲: 𝗥𝗕𝗤𝗠 𝗜𝗺𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 & 𝗗𝗮𝘁𝗮 𝗙𝗹𝗼𝘄 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝘀, on 5th December in Hyderabad. Speakers: Jalpa Ajmera Gangotri Boni Dr. Swathi Padival Prathibha Prabhakaran Krishnendu Sengupta Dr Syed Zoheb Quadri I am looking forward to networking with my peers and thought leaders in the field of Clinical Data Management. 𝗙𝗼𝗿 𝘁𝗵𝗼𝘀𝗲 𝗼𝗳 𝘆𝗼𝘂 𝘄𝗵𝗼 𝘄𝗮𝗻𝘁 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻 𝗮𝗯𝗼𝘂𝘁 𝗥𝗕𝗤𝗠: Risk-Based Quality Management (RBQM) in clinical trials is a strategic approach focusing on identifying, assessing, and mitigating risks that could impact the quality and integrity of a trial. It emphasizes proactive risk management throughout the trial lifecycle. Key Risk Indicators (KRIs) are metrics used to monitor potential risks, while Quality Tolerance Limits (QTLs) are predefined thresholds that trigger actions when exceeded. KRIs help in the early identification of issues, and QTLs ensure that the trial remains within acceptable quality boundaries. Together, they facilitate efficient resource allocation, enhance data quality, and ensure compliance with regulatory standards. Here are some examples of KRIs and QTLs used in clinical trials: 𝗞𝗲𝘆 𝗥𝗶𝘀𝗸 𝗜𝗻𝗱𝗶𝗰𝗮𝘁𝗼𝗿𝘀 (𝗞𝗥𝗜𝘀): --𝑷𝒓𝒐𝒕𝒐𝒄𝒐𝒍 𝑫𝒆𝒗𝒊𝒂𝒕𝒊𝒐𝒏𝒔: The number or frequency of deviations from the study protocol. --𝑷𝒂𝒕𝒊𝒆𝒏𝒕 𝑬𝒏𝒓𝒐𝒍𝒍𝒎𝒆𝒏𝒕 𝑹𝒂𝒕𝒆𝒔: Monitoring the rate at which patients are enrolled in the study compared to planned timelines. --𝑨𝒅𝒗𝒆𝒓𝒔𝒆 𝑬𝒗𝒆𝒏𝒕 𝑹𝒆𝒑𝒐𝒓𝒕𝒊𝒏𝒈: The frequency and severity of adverse events reported during the trial. --𝑫𝒂𝒕𝒂 𝑸𝒖𝒆𝒓𝒚 𝑹𝒂𝒕𝒆𝒔: The number of queries raised during data verification processes. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗧𝗼𝗹𝗲𝗿𝗮𝗻𝗰𝗲 𝗟𝗶𝗺𝗶𝘁𝘀 (𝗤𝗧𝗟𝘀): --𝑷𝒂𝒕𝒊𝒆𝒏𝒕 𝑫𝒓𝒐𝒑𝒐𝒖𝒕 𝑹𝒂𝒕𝒆: A predefined percentage of patient dropouts that, if exceeded, triggers a review or corrective action. --𝑫𝒂𝒕𝒂 𝑬𝒏𝒕𝒓𝒚 𝑻𝒊𝒎𝒆𝒍𝒊𝒏𝒆𝒔𝒔: The maximum allowable delay for entering data into the trial database after a patient visit. --𝑷𝒓𝒐𝒕𝒐𝒄𝒐𝒍 𝑪𝒐𝒎𝒑𝒍𝒊𝒂𝒏𝒄𝒆 𝑹𝒂𝒕𝒆: A threshold for the percentage of visits conducted according to the protocol. --𝑨𝒅𝒗𝒆𝒓𝒔𝒆 𝑬𝒗𝒆𝒏𝒕 𝑻𝒉𝒓𝒆𝒔𝒉𝒐𝒍𝒅: A specific number or rate of serious adverse events that, if reached, necessitates an investigation. These examples illustrate how KRIs and QTLs are used to monitor trial performance and maintain quality standards. Ghananeel Gondhali Srini Marimganti Venkata Sureshbabu Bondu Saurabh Singhal Milan Bhatt Siddhant Shukla Monish Ratthe Umesh Krishnan Vijaya Iyer Karunakar Sanna Hexaware Technologies #ClinicalTrials #Healthcare #Medicine

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Establishing a Data Ecosystem Using Automation to Optimize Regulatory-Compliant Clinical Trials Join this webinar series with Oracle to learn how to allocate time utilizing innovative systems without comprising regulatory compliance. Register now: https://ow.ly/CJem50RxGhB

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Jaswinder Chadha, CEO of Axtria, shares how it’s transforming pharma with data, GenAI, and innovative solutions to tackle rare diseases on #NYSEFloorTalk with Judy Khan Shaw. Axtria - Ingenious Insights

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🌟 Join the Conversation on Optimizing Clinical Trial Outcomes! 🌟 We're excited to announce that the TCS ADD™ team will be presenting at the SCDM India conference on the topic: "Optimizing Clinical Trial Outcomes: A Comprehensive Approach to Centralized Statistical Monitoring and Risk-Based Quality Management." While this event is taking place in India, we want to extend the conversation to our colleagues and industry leaders in the US, UK and EU. 🌍 Why is this important? Centralized Statistical Monitoring (CSM) and Risk-Based Quality Management (RBQM) are revolutionizing the way we conduct clinical trials. By leveraging advanced analytics and proactive risk management, we can enhance trial efficiency, ensure data integrity, and ultimately improve patient outcomes. What can you do? Engage with Us: Share your thoughts and experiences with CSM and RBQM. Let's discuss how these methodologies are shaping the future of clinical trials. Stay Informed: Follow our updates and insights from the conference. We'll be sharing key takeaways and innovative strategies that you can apply to your own work. Connect with Experts: Reach out to our team to learn more about our platform and how it can support your clinical trial needs. Let's drive the conversation forward and lead the way in clinical trial innovation! 🚀 #ClinicalTrials #RBQM #CSM #TCSADD #SCDMIndia #Pharma #Biotech #HealthcareInnovation #ClinicalResearch #SCDM #PharmaceuticalIndustry https://lnkd.in/g774yS2h

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GenAI is set to make profound impacts in the life sciences industry, from optimizing compliance processes to delivering personalized HCP experiences. But here’s the truth: success with GenAI isn’t automatic—it starts with laying the right groundwork. In our new blog, Ravivrat Pandey and Kamal Konidala break down:  1️⃣ Critical steps to organize content for automated creation.  2️⃣ Creating a robust compliance framework for faster MLR reviews.  3️⃣ Structuring metadata for smarter content management and tagging.  4️⃣ Building data foundations to enable real-time, personalized HCP engagement. Want to futureproof your organization for the AI-driven era? Start with the essentials. 👉 Read the full blog here: https://lnkd.in/diXPNiQ6 

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In recent years, the corporate healthcare landscape has transformed significantly, driven by digital integration. Read more about how technology is shaping the future of employee health management in my latest article.  #DigitalHealthcare #CorporateWellness #HealthTech 

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You know you are at Veeva Systems summit when industry leaders are discussing everything from what's new to exciting updates, trends, roadmaps etc. Here is a quick glimpse of how the event unfolded for us! #veevasummit #pinnaxis #pharmacovigilance #veevasafety #safetysystems #regulatory #pv #veevapartner

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