#clinical data management in pune

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Best Clinical Data Management Course in Pune - Lifepoint Research

When clinical trials are conducted, a huge amount of data gets generated. But how is this data collected and managed? Lifepoint provides the best clinical data management course in Pune

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https://www.ssodl.edu.in/clinical-data-management-course.php

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Clinical data management courses can provide professionals with a comprehensive understanding of the regulatory requirements governing clinical trials. Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines are essential frameworks that ensure the quality, safety, and efficacy of medical products.

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"The Role of SAS in Healthcare Analytics: Case Studies and Applications"

SAS plays a pivotal role in healthcare analytics by providing powerful tools for managing and analysing complex medical data. Here’s how SAS is utilized in the healthcare sector:

Predictive Modelling: SAS helps in developing predictive models to forecast patient outcomes, optimize treatment plans, and improve resource allocation. For instance, predictive analytics can identify patients at high risk for chronic diseases, enabling early intervention.

Clinical Trials Analysis: SAS is extensively used in analysing data from clinical trials. It facilitates statistical analysis of trial results, ensuring that findings are reliable and adhere to regulatory standards.

Operational Efficiency: Healthcare providers use SAS to streamline operations, manage patient records, and improve workflow efficiency. This includes analysing data to reduce wait times and enhance patient satisfaction.

Population Health Management: SAS enables the aggregation and analysis of data from diverse sources to track health trends, manage public health initiatives, and design targeted interventions.

Cost Analysis: By analysing cost data, SAS helps healthcare organizations identify cost-saving opportunities and improve financial management.

These applications demonstrate SAS’s critical role in transforming healthcare through data-driven insights and improved decision-making.

SAS Online Training Institute, Power BI, Python Pune, India (saspowerbisasonlinetraininginstitute.in)

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Synergen Bio, a leading name in the biopharmaceutical industry, is currently seeking immediate joiners for the position of Senior Research Associate in the Project Management and Bio-Pharmaceutics department. This role is based in Pune, Maharashtra, and offers an exciting opportunity for qualified professionals to contribute to cutting-edge pharmaceutical projects. Qualifications and Experience Required Qualifications: MSc in Life Sciences, B Pharmacy, M Pharmacy Experience: 2 to 4+ years of relevant experience in project management and bio-pharmaceutics Preferred: Candidates who can join immediately This role is ideal for individuals with a strong background in pharmaceutical sciences and project management, looking to advance their career in a dynamic and fast-paced environment. Job Responsibilities As a Senior Research Associate in Project Management and Bio-Pharmaceutics, you will be responsible for: Clinical Study Reports (CSR): Preparing CSRs for various regulatory bodies, including EMEA, WHO, SAHPRA, TGA, US-FDA, and Costa Rica, among others. e-CTD Proficiency: Managing electronic Common Technical Documents (e-CTD), including scanning, bookmarking, hyperlinking, optimization, and applying fast-web view. Creating and managing Tables of Contents (TOC) for PDFs. Regulatory Summary Reports: Compiling regulatory summary reports for different international bodies such as WHO, SAHPRA, TGA, US-FDA, and others. Biopharmaceutical Data Presentation: Preparing and presenting biopharmaceutical and bioanalytical data for regulatory submissions, including those for MHRA, EMEA, NPRA-Malaysia, and other regions. SDTM Knowledge: Applying knowledge of Study Data Tabulation Model (SDTM), particularly in relation to Bioavailability and Bioequivalence (BABE) studies. Regulatory Queries: Resolving queries from regulatory authorities, ensuring all submissions meet the required standards and timelines. [caption id="attachment_99243" align="aligncenter" width="930"] Synergen Bio Hiring Immediate Joiners for Project Management and Bio-Pharmaceutics[/caption] Location: Shivajinagar, Wakadewadi, Pune, Maharashtra Application Process Please share your updated CV with the relevant details at careers@synergenbio.com.

[haccpcertificationinseychelles]

ISO 15189 Certification in Botswana: Elevating Medical Laboratory Quality

ISO 15189 Certification in Botswana is an internationally recognized standard that specifies requirements for quality and competence in medical laboratories. It is designed to ensure that laboratories provide reliable, accurate, and timely results, which are critical for patient care and clinical decision-making. In Botswana, achieving ISO 15189 certification is a significant step for medical laboratories aiming to enhance their quality management systems and demonstrate their commitment to excellence in healthcare services.

ISO 15189 Implementation in Botswana

Implementing ISO 15189 in Botswana requires a comprehensive approach that involves aligning the laboratory’s operations with the standard’s requirements. The process begins with a thorough assessment of the existing laboratory practices to identify gaps that need to be addressed. This involves reviewing the laboratory’s quality management system (QMS), procedures, and processes to ensure they meet the standard’s stringent criteria.

Equipment calibration and maintenance are also critical components of ISO 15189 implementation. Laboratories must establish procedures for regular calibration, maintenance, and verification of all equipment used in testing. This ensures that the equipment provides accurate and reliable results, which are essential for patient safety.

Method validation is another crucial aspect of ISO 15189 implementation. Laboratories need to validate all testing methods to confirm their accuracy, precision, and reliability. This involves rigorous testing and documentation to ensure that the methods produce consistent and reproducible results.

Data integrity is paramount in ISO 15189 Implementation in Pune. Laboratories must establish robust procedures for data management, ensuring that all test results are accurately recorded, securely stored, and easily retrievable. This also involves implementing stringent controls to prevent unauthorized access or manipulation of data.

ISO 15189 Services in Botswana

Consulting services provide expert guidance on the implementation of ISO 15189 standards. Consultants work closely with laboratories to conduct a gap analysis, identify areas for improvement, and develop an action plan to address non-conformities. They assist in establishing and optimizing quality management systems, ensuring that all laboratory processes align with ISO 15189 requirements.

Training services are essential for building the necessary skills and knowledge among laboratory personnel. These services offer tailored training programs that cover various aspects of ISO 15189, including quality management, method validation, equipment calibration, and data management. Properly trained staff are crucial for maintaining ongoing compliance with the standard.

Certification services are provided by accredited bodies that assess the laboratory’s compliance with ISO 15189 standards. The certification process involves a thorough evaluation of the laboratory’s quality management system, procedures, and processes to ensure they meet the standard’s requirements. Upon successful completion of the audit, the laboratory is awarded ISO 15189 Services in Turkey, which serves as formal recognition of its competence and commitment to quality.

ISO 15189 Audit in Botswana

The ISO 15189 audit is a critical step in the certification process. In Botswana, this audit is conducted by an accredited certification body that evaluates the laboratory’s adherence to the standard’s requirements. The audit process involves a detailed review of the laboratory’s operations, including its quality management system, testing procedures, and data management practices.

During the audit, the certification body will assess various aspects of the laboratory’s performance, including staff competency, equipment calibration, method validation, and data integrity. The audit also involves on-site inspections, interviews with laboratory personnel, and a review of documentation to ensure that the laboratory meets all the criteria for ISO 15189 certification.

Laboratories should prepare for the audit by conducting internal audits and addressing any potential non-conformities. This preparation includes ensuring that all documentation is up to date, all procedures are properly documented, and all equipment is calibrated and maintained according to ISO 15189 standards.

Conclusion

ISO 15189 Certification in Botswana is a critical standard for medical laboratories striving to achieve excellence in quality and competence. By implementing the standard, utilizing available services, and successfully completing the audit process, laboratories can significantly enhance their operational efficiency, improve patient care, and strengthen their reputation in the healthcare sector. This certification not only demonstrates a commitment to quality but also provides a solid foundation for continuous improvement and global recognition.

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Clinical Research Courses in Pune |

Clinical Research Course

Diploma in Clinical Research (DCR)

1. Help candidates to gain knowledge about ICH-GCP Guidelines, regulatory issues and other major aspects of clinical research & trial management.

2. Giving insights on important facts responsible for conduct of actual research & clinical data management.

Duration (in months) :- 12 (Open and Distance Learning)

Intake :- 100

Reservation :- Not Applicable

Eligibility :- A Graduate from any recognized university/ institute.

Selection Procedure :- Based on fulfillment of eligibility norms and submission of documents

Medium of Instruction :- English

Programme Pattern :- Annual

Course and Specialization :- As per Annexure A

Fees :- INR 44,000

Assessment :- Each course will have continuous assessment of 70 % and term end assessment of 30% of total marks except campus contact session.

Standard of Passing :- Candidate should secure at least 50% passing in continuous assessment and term end assessment separately.

Award of grade towards campus contact session be based on student's attendance to the same as below:

AT: Attended

AB: Not attended

The student who fails to attend the campus contact session shall not be eligible for award of Diploma since this mandatory academic criterion is not fulfilled.

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Best Clinical Data Management Course in Pune - Lifepoint Research

When clinical trials are conducted, a huge amount of data gets generated. But how is this data collected and managed? Lifepoint provides the best clinical data management course in Pune.

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Unlocking the Potential of Data Science in the Pharmaceutical Realm

In the ever-evolving world of pharmaceuticals, the need for data-driven decision-making has become increasingly paramount. As the industry navigates the complexities of drug development, supply chain management, and patient engagement, the role of data science has emerged as a transformative force, empowering pharmaceutical companies to push the boundaries of innovation and excellence.

If you want to advance your career at the Data Science Training in Pune, you need to take a systematic approach and join up for a course that best suits your interests and will greatly expand your learning path.

Revolutionizing Drug Discovery through Data-Driven Exploration

The pharmaceutical industry's primary focus is the development of new and more effective treatments, a process that has historically been challenging and time-consuming. However, the integration of data science into this domain has ushered in a new era of drug discovery, where insights gleaned from vast datasets can expedite the identification of promising drug candidates and optimize the development pipeline.

By harnessing the power of advanced analytics, machine learning, and computational modeling, data scientists can uncover hidden patterns, simulate drug behavior, and make informed predictions – all of which can significantly accelerate the journey from concept to market.

Optimizing Clinical Trials and Ensuring Regulatory Compliance

The clinical trial phase is a critical juncture in the drug development process, where data scientists play a pivotal role in ensuring the success and compliance of these essential studies. Through the application of sophisticated analytical techniques, data scientists can identify potential risks, detect adverse events, and optimize trial design and patient recruitment.

This data-driven approach not only enhances the efficiency of clinical trials but also strengthens the pharmaceutical company's ability to navigate the complex regulatory landscape, ultimately increasing the chances of regulatory approval and market success.

Enhancing Supply Chain and Operations Resilience

Pharmaceutical supply chains are intricate, with numerous stakeholders, logistical challenges, and the need for stringent quality control. Data scientists bring a unique perspective to this domain, leveraging their analytical expertise to optimize inventory management, reduce waste, and streamline distribution networks.

By analyzing data on demand patterns, inventory levels, and transportation logistics, data scientists can help pharmaceutical companies make more informed decisions, reduce costs, and enhance the overall resilience of their supply chain operations.

For those looking to excel in Data Science, Data Science Online Training is highly suggested. Look for classes that align with your preferred programming language and learning approach.

Personalizing Patient Engagement and Improving Outcomes

In an era of patient-centric healthcare, the pharmaceutical industry has recognized the importance of understanding and addressing the unique needs of individuals. Data scientists play a crucial role in this endeavor, leveraging data from electronic health records, social media interactions, and wearable devices to develop personalized treatment plans, predict patient adherence, and identify opportunities to enhance the overall patient experience.

By harnessing the power of data-driven insights, pharmaceutical companies can tailor their products and services to better meet the needs of patients, ultimately improving healthcare outcomes and fostering stronger relationships with the communities they serve.

As the pharmaceutical industry continues to evolve, the integration of data science has become a strategic imperative. By embracing the transformative potential of data-driven insights, pharmaceutical companies can unlock new frontiers of innovation, optimize their operations, and deliver more personalized and effective healthcare solutions – ultimately, revolutionizing the industry and improving the lives of patients worldwide.

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Abhay Bhutada Foundation: Innovating Community Health in India

The Abhay Bhutada Foundation (ABF), founded by Abhay Bhutada, stands ready to significantly impact community health in India. With a strong foundation in finance and a commitment to using technology for good, Bhutada aims to revolutionize community health with innovative and sustainable solutions.

Abhay Bhutada: A Visionary in Leadership

Abhay Bhutada, the Founder and Chairman of the Abhay Bhutada Foundation, also serves as the Non-Executive Director on the Board of Poonawalla Fincorp Limited (PFL). Born and raised in Latur, Maharashtra, Bhutada graduated in Commerce from Symbiosis International University in 2005 and became a Chartered Accountant in 2009. His career began in 2010 as an SME Finance Professional with the Bank of India, quickly demonstrating his entrepreneurial talents and leadership abilities.

Bhutada, a former Managing Director of Poonawalla Fincorp, has received numerous accolades, including "Young Entrepreneur of India 2017," "Promising Entrepreneur of India 2019," and "40 under 40 Most Influential Leader for 2020-21." His dedication to corporate social responsibility, particularly in healthcare and education, laid the groundwork for ABF.

Also Read: Next Steps for Poonawalla Fincorp After Abhay Bhutada’s Shift to Non-Executive Director

The Abhay Bhutada Foundation: Mission and Vision

Incorporated on July 28, 2023, the Abhay Bhutada Foundation is a private not-for-profit organization based in Pune, Maharashtra. Its mission is to improve community health outcomes by addressing healthcare needs in underserved populations. With an authorized and paid-up capital of Rs 1.00 crore, ABF is positioned to fund and implement significant health initiatives.

Directors Narayan Jarange and Sujit Thite collaborate with Bhutada to ensure ABF's objectives are achieved. The foundation is classified under Business Activity Class/Subclass Code 88, emphasizing its focus on health and social work activities.

Also Read: Abhay Bhutada Foundation: A Commitment to Social Welfare

Technology in Health

Abhay Bhutada's vision of enhancing financial services through technology extends to his work with the Abhay Bhutada Foundation. ABF aims to make healthcare more accessible and efficient by leveraging digital tools and innovative solutions, particularly in rural and remote areas where healthcare infrastructure is lacking.

A key initiative of ABF is the development of telemedicine services, connecting patients with healthcare providers and reducing the need for travel. The foundation also plans to implement health information systems for better patient data tracking and health outcome monitoring.

Community Health Programs

The Abhay Bhutada Foundation is dedicated to addressing various health issues affecting communities across India. Key initiatives include:

Preventive Healthcare Programs: ABF organizes health camps, vaccination drives, and awareness campaigns on hygiene and nutrition to reduce chronic disease incidence.

Maternal and Child Health: ABF prioritizes the health of mothers and children, providing prenatal and postnatal care, along with educational programs for expecting and new mothers.

Mental Health Support: Recognizing mental well-being's importance, ABF offers mental health services, including counseling and support groups.

Health Infrastructure Development: ABF invests in building and upgrading healthcare facilities in underserved areas, including setting up clinics, providing medical equipment, and training healthcare workers.

Also Read: Abhay Bhutada Foundation and Its Mission for Social Change

The Future of Community Health

Under Abhay Bhutada's leadership, the Abhay Bhutada Foundation is poised to play a pivotal role in transforming community health in India. By combining innovative technology with a compassionate approach, ABF aims to create sustainable health solutions benefiting millions.

As Bhutada assumes a strategic role at the Cyrus Poonawalla Group, his commitment to improving healthcare through the foundation remains steadfast. His involvement in industry forums such as CII, ASSOCHAM, FICCI, and FIDC amplifies his dedication to driving positive change in healthcare.

Conclusion

The Abhay Bhutada Foundation represents a beacon of hope for communities in need of better healthcare. With Abhay Bhutada's visionary leadership and a dedicated team, ABF is well-prepared to address community health challenges and pave the way for a healthier future. By leveraging technology and focusing on preventive care, maternal and child health, mental health support, and infrastructure development, the foundation is set to make a lasting impact on countless individuals' well-being across India.

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Cognizant Hiring Trainee - Junior Data Analyst Are you ready to start your career with a global leader in professional services? Cognizant is looking for enthusiastic graduates and postgraduates in life sciences, pharmacy, medical sciences, or nursing to join our pune team as Trainee - Junior Data Analysts. Job Details Position: Trainee - Junior Data Analyst Location: Pune Qualifications: Graduate/Post Graduate/Doctorate in life sciences, pharmacy, medical sciences, or registered nurse Experience Level: Entry-level Key Responsibilities of Trainee - Junior Data Analyst Business/ Customer: Minimal Customer interaction under guidance. Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists). For PV/Complaints Management Individuals in this role perform data entry of data received from Source documents into the respective Clinical/Safety database While peroforming this activity the associate is responsible for meeting turnaround times and accuracy. For PV/Complaints Management Individuals in this role perform data entry of data received from Source documents into the respective Clinical/Safety database While peroforming this activity the associate is responsible for meeting turnaround times and accuracy.Minimal Customer interaction under guidance. Understands Domain Process/sub process, functions, terminologies (such as SOP, QC checklists). CODING: (same as SPE) Perform coding activities on the assigned project with timelines and efficiency. Import uncoded terms in database and export coded medical terms from coding platform. Query Management. Create “New Term Request” and prioritize.  Perform Dictionary upversioning activity as and when required. CDM: Limited to study conduct activities. Data review and Query management is done with assistance. Limited email conversations with Client. Every activity requires Peer QC by supervisor or allocated seniors. NO INVOLVEMENT in Set Up and Migration activities. Limited involvement of data pad locking activities during timelines of DataBase locks. Project / Process: Handles First level processing of assigned transactions, Complex problems (procedures/processes) are referred to Supervisor/Line Manager. Adhere to quality requirements, achieve targets/volumes in given TAT(Turn around time). Adhere to the mandatory industry regulation and compliance requirements for the given process. Knowledge Management: Understand various document templates and standards(Such as SOP's) to interpret the documents & related terminologies. People/Team Management: Adhere to org hygiene and compliance needs in terms of Time sheet submission, Assimilation & Attendance. Desired Skills Pharmacovigilance & Safety Operations PV Case Processing [caption id="attachment_83152" align="aligncenter" width="1200"] Cognizant Hiring Trainee - Junior Data Analyst[/caption] Why Join Cognizant? Supportive Environment: Work in an energetic, collaborative, and inclusive workplace. Global Presence: Join a global community of over 345,000 associates. Innovation Driven: Build a career path in a forward-thinking and innovative environment. Commitment to Doing Right: We take care of our people, clients, company, communities, and climate by doing what’s right. About Cognizant Cognizant (Nasdaq-100: CTSH) is a leading professional services company, helping organizations modernize technology, reimagine processes, and transform experiences to stay ahead in a fast-changing world. Our Commitment to Diversity and Inclusion Cognizant is an equal opportunity employer that embraces diversity, champions equity, and values inclusion. We nurture a community where everyone feels heard, accepted, and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status, or any other protected characteristic as outlined by federal, state, or local laws.

Application Process Interested candidates are encouraged to apply online. Be prepared to attend interviews in person or via video conference and present your current state or government-issued ID during each interview. Apply Here: Cognizant Careers - Trainee Junior Data Analyst Disclaimer Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

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Role of Mprex as a Premier Clinical Research Organization in Pune

In the vibrant city of Pune, where innovation meets tradition, a beacon of excellence shines bright in the field of healthcare. Mprex, a premier Clinical Research Organization (CRO) dedicated to pioneering medical breakthroughs. With a rich tapestry of academic institutions, healthcare facilities, and research centers, Pune is the ideal backdrop for Mprex's mission to transform the landscape of clinical research. In this blog post, we'll delve into the pivotal role played by Mprex as a leading CRO for nutraceuticals and its contributions to advancing medical science.

Commitment to Excellence: Mprex epitomizes excellence in clinical research, offering a comprehensive suite of services designed to support pharmaceutical, biotechnology, and medical device companies throughout the drug development lifecycle. From protocol development and regulatory affairs to clinical trial management and data analysis, Mprex provides end-to-end solutions that adhere to the highest standards of quality and compliance. By combining scientific expertise with operational excellence, Mprex ensures the successful execution of nutraceutical clinical trials in india and beyond, driving innovation and delivering life-changing therapies to patients worldwide.

Fostering Collaboration and Innovation: At Mprex, collaboration is at the core of our approach to clinical research. We believe that by bringing together diverse stakeholders, including researchers, clinicians, patients, and industry partners, we can accelerate the pace of medical innovation and drive meaningful change. Through strategic partnerships with leading academic institutions and healthcare organizations in Pune, Mprex fosters an ecosystem of collaboration and knowledge exchange, facilitating the translation of scientific discoveries into clinical practice. By harnessing the collective expertise of our partners, Mprex is pushing the boundaries of what's possible in healthcare and ushering in a new era of medical breakthroughs.

Empowering Patients and Communities: Mprex is committed to empowering patients and communities in Pune by ensuring access to cutting-edge treatments and therapies through clinical trials. We understand the importance of patient-centricity in clinical research and strive to engage patients as partners in the research process. Through patient advocacy initiatives, educational outreach programs, and community engagement efforts, Mprex raises awareness about the benefits of clinical trials and encourages participation from diverse patient populations. By placing patients at the center of our research efforts, Mprex is not only advancing medical science but also improving healthcare outcomes and enhancing the quality of life for patients in Pune and beyond.

Looking Ahead: As Pune continues to emerge as a hub for healthcare innovation and research, the future of clinical research holds immense promise. With Mprex leading the charge, Pune is poised to make significant contributions to the global healthcare landscape, driving innovation, and improving patient care. By remaining committed to excellence, collaboration, and patient-centricity, Mprex will continue to pave the way for groundbreaking discoveries and transformative therapies that have the power to change lives. Together, we will shape the future of healthcare in Pune and beyond, one breakthrough at a time.

In Pune's dynamic healthcare ecosystem, Mprex stands as a beacon of innovation and excellence, driving forward the frontiers of clinical research and healthcare delivery. Through our unwavering commitment to excellence, collaboration, and patient empowerment, we are shaping a future where breakthrough treatments are within reach for all. As we continue our journey of discovery and innovation, Mprex remains dedicated to making a meaningful difference in the lives of patients and communities in Pune and around the world.

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Clinical Data Management Courses in Pune - Confianza ClinPharm Solutions

Make your career in CDM with our Clinical data management courses in Pune. Read the article to learn about this course, its scope, roles and responsibilities in Clinical Research Trials.