Sovereign Health is a clinical trial management organization that conducts global clinical trials in compliance with international standards. It was established in 2006 to improve site-level services for high-quality international clinical trials. Sovereign owns dedicated clinical research sites and provides support to ensure accurate, consistent clinical data generation according to international guidelines. The company's network of sites covers a diverse population and provides specialist expertise in areas like central nervous system studies.
Sovereign Health is a clinical trial management organization in India that provides clinical research services to pharmaceutical, biotech, and medical device companies. It has experience conducting trials across many therapeutic areas in India and aims to generate high-quality, compliant research data. Sovereign Health has an extensive network of over 600 investigators across India and staff to support trials from project management to regulatory services. It works to ensure client satisfaction and quality trial conduct through internal monitoring, training programs, and 24/7 customer support.
This document summarizes a project report submitted by a team of six individuals on Dutech Clinica, a clinical site management organization, from a sponsor's perspective. It discusses Dutech Clinica's track record of on-time trial delivery, competitive project management team, high quality data with regulatory compliance, and ability to rapidly recruit and retain patients. It also provides an overview of the topics covered in the project report, including introduction to clinical site management, clinical trial planning and management, feasibility analysis, clinical research coordination, quality control management, and clinical trial document management.
QPS Bio-Kinetic is a clinical research organization located in Springfield, Missouri that specializes in Phase I-IV clinical trials. It has a state-of-the-art facility with 240 beds across 5 study units. QPS Bio-Kinetic has over 15 years of experience conducting over 800 studies and has a dedicated, experienced staff with low turnover. Customers praise QPS Bio-Kinetic for its ability to reliably deliver high quality results on time and on budget.
City X Ray & Scan Clinic provides comprehensive clinical testing and diagnostic services under one roof. It aims to deliver world-class and affordable diagnostic facilities to all sections of society while maintaining high ethical standards. The clinic offers a wide range of pathology, radiology, and imaging services using state-of-the-art equipment. It has received several accreditations for its emphasis on quality, accurate reporting, and trained staff. The document outlines the clinic's vision, services, equipment, quality initiatives, and leadership team.
The document outlines the assessment process and scoring methodology for the Kayakalp program, which aims to promote cleanliness, hygiene and infection control in public health facilities in India. It describes the various themes (areas of assessment), criteria, checkpoints and scoring system used. It provides details on the roles and responsibilities of internal and external assessment teams, as well as pre-assessment, during assessment and post-assessment activities like gap analysis and action planning. The goal is to help facilities improve cleanliness standards through a continuous assessment and quality improvement cycle.
Standard infrastructure for quality eye care serviceslionsleaders
This document discusses standards for quality eye care services and infrastructure. It outlines key aspects of quality including professional performance, use of resources, risk management, and patient satisfaction. Key components of quality infrastructure are proper planning, equipment, trained staff, record maintenance, and accreditations. The document also discusses layout and facilities for outpatient departments, inpatient wards, operating theaters, and overall hospital infrastructure and emphasizes the importance of standardized procedures, staff training, and accreditation in ensuring quality of care.
Sherin Kunjamma Raj is a Medical Laboratory Technologist with over 10 years of experience working in laboratories in Saudi Arabia and India. She has a BSc in Medical Laboratory Technology and is SCHS certified. She is seeking a full-time position where she can utilize her expertise in areas like biochemistry, hematology, bacteriology, and serology. She has strong skills in laboratory procedures, quality management, and equipment operation and is able to work accurately under pressure.
Sovereign Health is a clinical trial management organization in India that provides clinical research services to pharmaceutical, biotech, and medical device companies. It has experience conducting trials across many therapeutic areas in India and aims to generate high-quality, compliant research data. Sovereign Health has an extensive network of over 600 investigators across India and staff to support trials from project management to regulatory services. It works to ensure client satisfaction and quality trial conduct through internal monitoring, training programs, and 24/7 customer support.
This document summarizes a project report submitted by a team of six individuals on Dutech Clinica, a clinical site management organization, from a sponsor's perspective. It discusses Dutech Clinica's track record of on-time trial delivery, competitive project management team, high quality data with regulatory compliance, and ability to rapidly recruit and retain patients. It also provides an overview of the topics covered in the project report, including introduction to clinical site management, clinical trial planning and management, feasibility analysis, clinical research coordination, quality control management, and clinical trial document management.
QPS Bio-Kinetic is a clinical research organization located in Springfield, Missouri that specializes in Phase I-IV clinical trials. It has a state-of-the-art facility with 240 beds across 5 study units. QPS Bio-Kinetic has over 15 years of experience conducting over 800 studies and has a dedicated, experienced staff with low turnover. Customers praise QPS Bio-Kinetic for its ability to reliably deliver high quality results on time and on budget.
City X Ray & Scan Clinic provides comprehensive clinical testing and diagnostic services under one roof. It aims to deliver world-class and affordable diagnostic facilities to all sections of society while maintaining high ethical standards. The clinic offers a wide range of pathology, radiology, and imaging services using state-of-the-art equipment. It has received several accreditations for its emphasis on quality, accurate reporting, and trained staff. The document outlines the clinic's vision, services, equipment, quality initiatives, and leadership team.
The document outlines the assessment process and scoring methodology for the Kayakalp program, which aims to promote cleanliness, hygiene and infection control in public health facilities in India. It describes the various themes (areas of assessment), criteria, checkpoints and scoring system used. It provides details on the roles and responsibilities of internal and external assessment teams, as well as pre-assessment, during assessment and post-assessment activities like gap analysis and action planning. The goal is to help facilities improve cleanliness standards through a continuous assessment and quality improvement cycle.
Standard infrastructure for quality eye care serviceslionsleaders
This document discusses standards for quality eye care services and infrastructure. It outlines key aspects of quality including professional performance, use of resources, risk management, and patient satisfaction. Key components of quality infrastructure are proper planning, equipment, trained staff, record maintenance, and accreditations. The document also discusses layout and facilities for outpatient departments, inpatient wards, operating theaters, and overall hospital infrastructure and emphasizes the importance of standardized procedures, staff training, and accreditation in ensuring quality of care.
Sherin Kunjamma Raj is a Medical Laboratory Technologist with over 10 years of experience working in laboratories in Saudi Arabia and India. She has a BSc in Medical Laboratory Technology and is SCHS certified. She is seeking a full-time position where she can utilize her expertise in areas like biochemistry, hematology, bacteriology, and serology. She has strong skills in laboratory procedures, quality management, and equipment operation and is able to work accurately under pressure.
The Kayakalp initiative aims to promote cleanliness, hygiene, and infection control at public health facilities in India. A new theme of "Eco-friendly Health Facilities" has been added to the existing Kayakalp assessment tool to evaluate facilities on energy efficiency, pollution reduction, waste management, and environmental protection. A separate award category for the best "Eco-friendly" hospital has also been introduced, with awards of 10 lakhs for the best district hospital and 5 lakhs for the best community health center or sub-district hospital. Facilities will be evaluated based on their eco-friendly scores according to the revised Kayakalp checklist criteria on eco-friendly practices, waste management,
Quality assurance programs overview in government hospitalUpendra Kushwah
The document discusses quality assurance in healthcare. It defines quality as meeting predetermined standards and customer expectations through minimizing variations and standardization. It outlines aims to ensure access to quality health services and satisfaction among users. Key aspects of quality include effectiveness, efficiency, equity, safety, timeliness and patient-centeredness. The document then provides details on quality assurance programs and assessments at the district, state and national level including formation of quality teams, indicators, audits, certifications and more. It discusses several specific quality programs like LaQshya for maternal and child health, SUMAN for maternal healthcare and Kayakalp for cleanliness in public health facilities.
Genelife Clinical Research is a technologically advanced CRO that aims to reduce drug development timelines through high quality services. It provides comprehensive clinical trial services from early phase to late phase trials across multiple therapeutic areas globally. Genelife utilizes experienced professionals and innovative tools to efficiently manage projects and ensure quality and regulatory compliance. Its goal is to become the most respected partner in providing product development and meeting unmet clinical research needs.
Illustration on how the CPGs Adaptation Program has helped in quality improvement through compliance with national and international accreditation standards.
Purpose of the call:
To learn about:
•successful strategies and approaches to engage patients and caregivers in MedRec,
•how teams effectively dialogue with patients and their caregivers on the benefits of having an accurate medication list, and
•the development of paper and electronic tools and resources created for patients and their caregivers to create and maintain their medication lists.
Watch the webinar http://bit.ly/1fnE61V
The document summarizes guidelines being developed for infrastructure standards across South Africa's public health system. It discusses the current state of inconsistent infrastructure quality and the initiative to create a sustainable set of guidelines covering all stages of the health facility lifecycle. The standards will impact clinical engineers by providing maintenance best practices focusing on strategic asset knowledge, risk-based prioritization, and continuous improvement. The guidelines are being implemented nationally to improve infrastructure planning, budgeting, and quality in South Africa's public health system.
7 day services practical tips for achieving consultant review of patients wit...NHS England
Sue Cottle, Programme Lead, 7 Day Services, Sustainable Improvement, NHS England South
Celia Ingham Clark, MBE, Medical Director for Clinical Effectiveness, NHS England
Claire Gorzanski, Head of Clinical Effectiveness, Salisbury NHS Foundation Trust
Sam Burrows, Director of Strategy, NHS Wokingham CCG
This webinar aims to provide you with:
An overview of the updated guidance for the priority clinical standards and timing of the forthcoming self-assessment survey
Practical examples of how commissioners and acute providers are working together to support delivery of timely Consultant assessment (clinical standard 2) – their successes, challenges and opportunities
An opportunity to ask questions of your colleagues and identify key areas of support required
Quality Management Systems in Radiotherapy based on ISO 9001 standardVal Antoff
Presentation on the main building blocks of a Quality Management System in Radiotherapy based on the international ISO 9001 standard. The presentation provides internal hyperlinks to bookmarked material for easy navigation.
This document discusses strategies to optimize transcatheter aortic valve replacement (TAVR) programs, including:
1. Implementing a minimalist approach to TAVR procedures using local anesthesia and conscious sedation in the catheterization lab, rather than general anesthesia in the hybrid operating room, which can reduce procedure time, intensive care unit stay, length of stay, and hospital costs.
2. Developing standardized clinical pathways and protocols for pre-procedure patient evaluation and selection, the TAVR procedure itself, and post-procedure recovery, in order to decrease length of stay and readmissions while improving outcomes.
3. Considering ways to decrease resource utilization such as reducing hospital staff duplication, streamlining procedure-
This document contains charts and graphs showing the total number of cataract surgeries performed each year from 2007-2008 to 2013-2014, with numbers rising from around 5.4 million to over 6.1 million. It discusses the importance of safe, high-quality and affordable cataract surgery and lists equipment and technologies needed to properly perform surgeries. It also discusses metrics like intervention ratio, pre-and post-operation vision to measure quality of care, and suggests separating free/subsidized care from paid services to better serve different populations. Quality is defined as discipline, preparedness, affordability and doing things right even when unobserved.
R&D Partners is a specialty search firm that recruits clinical research and regulatory affairs candidates for pharmaceutical, biotech, diagnostic, and medical device clients. They focus on project management, trial management, monitoring, data management, medical writing, and regulatory affairs positions. R&D Partners prioritizes long-term client relationships based on trust, consistency, and excellence. They have a team of experienced account managers and recruit consultants and permanent hires in areas like clinical research, regulatory affairs, validation, compliance, and quality.
Radiology workflow recognizing clinical financial benefits of implementing a ...Trimed Media Group
The document discusses the benefits of implementing a full RIS-PACS-reporting solution at Rutland Regional Medical Center. It allows for a tightly connected workflow from patient arrival to report delivery. Physicians have efficient access to images and information. The single vendor system provides radiologists with a quick turnaround and unified vision. Key metrics like report turnaround time and coding callbacks have improved. The solution enhances patient care by making the physician workflow more efficient.
What are the benefits of QMS for a fertility centre and how do we measure themSandro Esteves
This document discusses the benefits of implementing a Quality Management System (QMS) for a fertility center. It explains that a QMS helps ensure consistency, meet customer needs, and increase efficiency. Benefits are measured through audits, tracking quality actions, and key performance indicators. Tools like Pareto diagrams, control charts, and the PDCA method are used to analyze data. The presentation then discusses Androfert fertility center's experience implementing ISO 9001 certification in 2006. This helped Androfert improve quality of services, comply with regulations, boost its reputation, increase market share and profitability over time. The QMS created a well-organized workflow and focus on continuous improvement.
Bruce Cole has over 20 years of experience in Navy medicine, including mid-level management in quality management, continuous process improvement, data analysis, staff training, and enlisted leadership. He has expertise in statistical reporting, records management, and using various software programs. Currently he works as a Medical Support Assistant at the Naval Medical Center in San Diego, providing administrative support to promote patient care.
The document provides an overview of City X Ray & Scan Clinic, a medical diagnostics center. Its vision is to deliver excellent patient care and benchmark quality diagnostics using ethical practices and continuous upgrades. The mission is to provide world-class and affordable diagnostic facilities to all while maintaining high standards. The clinic offers a wide range of diagnostic tests and services across radiology, pathology, cardiology, and other specialties using state-of-the-art equipment. It is committed to quality, timely reporting, and a good patient and doctor experience through well-trained staff and efficient systems. The clinic has received several accreditations and aims to set new benchmarks in healthcare delivery through continuous improvements.
This corporate presentation from May 2015 introduces B&A, a leading CRO in Latin America known for its precise, reliable, and cost-efficient clinical research services. It discusses B&A's vision of providing tailored clinical research services to meet client needs for success, quality, and efficiency based on regional expertise. The presentation outlines B&A's core values and services including clinical monitoring, regulatory setup, project management, site identification and evaluation, and safety monitoring. It highlights B&A's experience across therapeutic areas and phases of clinical trials as well as its clients, team, and recent awards and expansion plans.
KPS Clinical Services (KPSCS) is set up by the RAHE Group, with an aim to become one of the India's leading research-based Contract Research Organization (CRO). Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device companies, academic and government organizations.
We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavor, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by KPSCS are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.
Altasciences Clinical Research offers comprehensive early stage drug development services including Phase I/II clinical trials, bioanalytical services, clinical data management, biostatistics, and pharmacokinetic/pharmacodynamic analysis. They have facilities in the US and Canada with over 600 beds for clinical trials. Altasciences specializes in areas like abuse liability, biosimilars, and cognitive testing and has partnerships to complement their service offerings. Patient safety is their top priority with 24/7 medical coverage and emergency response procedures.
Project Management at GVK BIO is led by skilled and highly motivated executives with experience averaging 6-7 years. Our Project Managers (PMs) employ proven planning, time management, problem solving and communication skills to ensure timely project delivery,
determined to exceed customer expectations.
The Kayakalp initiative aims to promote cleanliness, hygiene, and infection control at public health facilities in India. A new theme of "Eco-friendly Health Facilities" has been added to the existing Kayakalp assessment tool to evaluate facilities on energy efficiency, pollution reduction, waste management, and environmental protection. A separate award category for the best "Eco-friendly" hospital has also been introduced, with awards of 10 lakhs for the best district hospital and 5 lakhs for the best community health center or sub-district hospital. Facilities will be evaluated based on their eco-friendly scores according to the revised Kayakalp checklist criteria on eco-friendly practices, waste management,
Quality assurance programs overview in government hospitalUpendra Kushwah
The document discusses quality assurance in healthcare. It defines quality as meeting predetermined standards and customer expectations through minimizing variations and standardization. It outlines aims to ensure access to quality health services and satisfaction among users. Key aspects of quality include effectiveness, efficiency, equity, safety, timeliness and patient-centeredness. The document then provides details on quality assurance programs and assessments at the district, state and national level including formation of quality teams, indicators, audits, certifications and more. It discusses several specific quality programs like LaQshya for maternal and child health, SUMAN for maternal healthcare and Kayakalp for cleanliness in public health facilities.
Genelife Clinical Research is a technologically advanced CRO that aims to reduce drug development timelines through high quality services. It provides comprehensive clinical trial services from early phase to late phase trials across multiple therapeutic areas globally. Genelife utilizes experienced professionals and innovative tools to efficiently manage projects and ensure quality and regulatory compliance. Its goal is to become the most respected partner in providing product development and meeting unmet clinical research needs.
Illustration on how the CPGs Adaptation Program has helped in quality improvement through compliance with national and international accreditation standards.
Purpose of the call:
To learn about:
•successful strategies and approaches to engage patients and caregivers in MedRec,
•how teams effectively dialogue with patients and their caregivers on the benefits of having an accurate medication list, and
•the development of paper and electronic tools and resources created for patients and their caregivers to create and maintain their medication lists.
Watch the webinar http://bit.ly/1fnE61V
The document summarizes guidelines being developed for infrastructure standards across South Africa's public health system. It discusses the current state of inconsistent infrastructure quality and the initiative to create a sustainable set of guidelines covering all stages of the health facility lifecycle. The standards will impact clinical engineers by providing maintenance best practices focusing on strategic asset knowledge, risk-based prioritization, and continuous improvement. The guidelines are being implemented nationally to improve infrastructure planning, budgeting, and quality in South Africa's public health system.
7 day services practical tips for achieving consultant review of patients wit...NHS England
Sue Cottle, Programme Lead, 7 Day Services, Sustainable Improvement, NHS England South
Celia Ingham Clark, MBE, Medical Director for Clinical Effectiveness, NHS England
Claire Gorzanski, Head of Clinical Effectiveness, Salisbury NHS Foundation Trust
Sam Burrows, Director of Strategy, NHS Wokingham CCG
This webinar aims to provide you with:
An overview of the updated guidance for the priority clinical standards and timing of the forthcoming self-assessment survey
Practical examples of how commissioners and acute providers are working together to support delivery of timely Consultant assessment (clinical standard 2) – their successes, challenges and opportunities
An opportunity to ask questions of your colleagues and identify key areas of support required
Quality Management Systems in Radiotherapy based on ISO 9001 standardVal Antoff
Presentation on the main building blocks of a Quality Management System in Radiotherapy based on the international ISO 9001 standard. The presentation provides internal hyperlinks to bookmarked material for easy navigation.
This document discusses strategies to optimize transcatheter aortic valve replacement (TAVR) programs, including:
1. Implementing a minimalist approach to TAVR procedures using local anesthesia and conscious sedation in the catheterization lab, rather than general anesthesia in the hybrid operating room, which can reduce procedure time, intensive care unit stay, length of stay, and hospital costs.
2. Developing standardized clinical pathways and protocols for pre-procedure patient evaluation and selection, the TAVR procedure itself, and post-procedure recovery, in order to decrease length of stay and readmissions while improving outcomes.
3. Considering ways to decrease resource utilization such as reducing hospital staff duplication, streamlining procedure-
This document contains charts and graphs showing the total number of cataract surgeries performed each year from 2007-2008 to 2013-2014, with numbers rising from around 5.4 million to over 6.1 million. It discusses the importance of safe, high-quality and affordable cataract surgery and lists equipment and technologies needed to properly perform surgeries. It also discusses metrics like intervention ratio, pre-and post-operation vision to measure quality of care, and suggests separating free/subsidized care from paid services to better serve different populations. Quality is defined as discipline, preparedness, affordability and doing things right even when unobserved.
R&D Partners is a specialty search firm that recruits clinical research and regulatory affairs candidates for pharmaceutical, biotech, diagnostic, and medical device clients. They focus on project management, trial management, monitoring, data management, medical writing, and regulatory affairs positions. R&D Partners prioritizes long-term client relationships based on trust, consistency, and excellence. They have a team of experienced account managers and recruit consultants and permanent hires in areas like clinical research, regulatory affairs, validation, compliance, and quality.
Radiology workflow recognizing clinical financial benefits of implementing a ...Trimed Media Group
The document discusses the benefits of implementing a full RIS-PACS-reporting solution at Rutland Regional Medical Center. It allows for a tightly connected workflow from patient arrival to report delivery. Physicians have efficient access to images and information. The single vendor system provides radiologists with a quick turnaround and unified vision. Key metrics like report turnaround time and coding callbacks have improved. The solution enhances patient care by making the physician workflow more efficient.
What are the benefits of QMS for a fertility centre and how do we measure themSandro Esteves
This document discusses the benefits of implementing a Quality Management System (QMS) for a fertility center. It explains that a QMS helps ensure consistency, meet customer needs, and increase efficiency. Benefits are measured through audits, tracking quality actions, and key performance indicators. Tools like Pareto diagrams, control charts, and the PDCA method are used to analyze data. The presentation then discusses Androfert fertility center's experience implementing ISO 9001 certification in 2006. This helped Androfert improve quality of services, comply with regulations, boost its reputation, increase market share and profitability over time. The QMS created a well-organized workflow and focus on continuous improvement.
Bruce Cole has over 20 years of experience in Navy medicine, including mid-level management in quality management, continuous process improvement, data analysis, staff training, and enlisted leadership. He has expertise in statistical reporting, records management, and using various software programs. Currently he works as a Medical Support Assistant at the Naval Medical Center in San Diego, providing administrative support to promote patient care.
The document provides an overview of City X Ray & Scan Clinic, a medical diagnostics center. Its vision is to deliver excellent patient care and benchmark quality diagnostics using ethical practices and continuous upgrades. The mission is to provide world-class and affordable diagnostic facilities to all while maintaining high standards. The clinic offers a wide range of diagnostic tests and services across radiology, pathology, cardiology, and other specialties using state-of-the-art equipment. It is committed to quality, timely reporting, and a good patient and doctor experience through well-trained staff and efficient systems. The clinic has received several accreditations and aims to set new benchmarks in healthcare delivery through continuous improvements.
This corporate presentation from May 2015 introduces B&A, a leading CRO in Latin America known for its precise, reliable, and cost-efficient clinical research services. It discusses B&A's vision of providing tailored clinical research services to meet client needs for success, quality, and efficiency based on regional expertise. The presentation outlines B&A's core values and services including clinical monitoring, regulatory setup, project management, site identification and evaluation, and safety monitoring. It highlights B&A's experience across therapeutic areas and phases of clinical trials as well as its clients, team, and recent awards and expansion plans.
KPS Clinical Services (KPSCS) is set up by the RAHE Group, with an aim to become one of the India's leading research-based Contract Research Organization (CRO). Our commitment is to improve the quality of human life & to provide world class clinical research services to pharmaceutical, biotechnology, medical device companies, academic and government organizations.
We wish to focus on the prevailing issues in clinical research & give their solutions with a fresh and rational approach. In this endeavor, we have successfully established a team of highly qualified and experienced multi-disciplinary GCP trained personnel. The services provided by KPSCS are knowledge-driven and based on the understanding of the pharmacology and molecular basis of disease. We believe in providing quality services & we prioritize customer relationships.
Altasciences Clinical Research offers comprehensive early stage drug development services including Phase I/II clinical trials, bioanalytical services, clinical data management, biostatistics, and pharmacokinetic/pharmacodynamic analysis. They have facilities in the US and Canada with over 600 beds for clinical trials. Altasciences specializes in areas like abuse liability, biosimilars, and cognitive testing and has partnerships to complement their service offerings. Patient safety is their top priority with 24/7 medical coverage and emergency response procedures.
Project Management at GVK BIO is led by skilled and highly motivated executives with experience averaging 6-7 years. Our Project Managers (PMs) employ proven planning, time management, problem solving and communication skills to ensure timely project delivery,
determined to exceed customer expectations.
Service Overview
Site management services to CRO and SITE:
A) Pre initiation
Identification of Potential Sites
Faster Feasibility
Site set up, supplies and other infrastructure needs
Regulatory and IEC/ IRB communications
Rapid negotiation of CTA
Setting up Standard Operating Procedures (SOPs)
B) During Study Duration
Provide dedicated trained and experienced CRCs (Clinical research coordinators)
Patient recruitment & retention Support
Maintenance of essential documents
Source documentation as per ALCOA standards (Attributable, Legible, Contemporaneous, Original & Accurate
Regular IP (Investigational Product) accountability and storage
Completion of CRF’s within timelines
Faster query resolution
Reporting of AE, SAEs within timelines
Support Monitoring visits and Quality Assurance audit action items.
Patient visit Follow Up and compliance assistance
Preparation of site for monitoring and audits/ inspections
C) Post Close out
· Archiving of site results and documents
Site Identification
Faster Feasibility
Ready Sites
An ever-evolving regulatory environment makes navigating gene therapy products through to clinic much more complicated than a traditional biologic. While manufacturing platforms and regulatory requirements for testing of antibodies has existed for decades, gene therapy platforms and their testing requirements are changing rapidly with the progression of products toward commercialization.
Human Care Research is an independent clinical research organization located in Mumbai, India that provides a wide range of clinical trial services including project management, clinical operations, preclinical operations, data management, medical writing, and regulatory services. It has a network of qualified principal investigators across India and adheres to ICH/GCP guidelines, Indian GCP, and US FDA regulations. Its goal is to support successful clinical trials and drug development through strict ethics and quality standards.
Clinical Research Organization Services | Contract Research Company - PepgraPEPGRA Healthcare
Pepgra is a global contract research organization and drug development services company. It provides various phases of clinical research trials services to pharmaceutical and biotechnology companies to help reduce the time and costs associated with drug development.
Contact Us:
Website : https://bit.ly/33Fwsye
Email us: sales.cro@pepgra.com
India: +91 9884350006
United Kingdom: +44- 74248 10299
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
This document provides information about CARE Worldwide Inc, a clinical research organization that conducts clinical trials. It describes CARE's global network of clinical trial sites and staff, including principal investigators, clinical research associates, clinical data managers, and other roles. It also discusses the clinical trial process, importance of training for clinical research professionals, and career opportunities in the field. The goal is to support pharmaceutical and medical device companies through quality clinical trials.
Max Neeman International is India’s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies.
Advance Your Program in China with Fully Integrated Clinical Development Solu...Covance
Meet your needs for greater efficiency, expanded capacity and customized support at the newly opened Covance Drug Development Center in Shanghai, China.
A well-conceived and executed IND-enabling preclinical program and completion of early clinical trials will provide you with a detailed assessment of your drug candidate including the most cost-effective and timely pathway to filing an IND and completion of the “proof-of-concept” studies. During execution of your IND-enabling program you will benefit from QPS’ operational strengths, strong scientific/regulatory pre-IND/IND support and drug development experience.
Whether you are looking for staff in the biotechnology, primary pharmaceutical, secondary pharmaceutical or fine chemicals sectors, we can supply the best talent globally.
The document provides information on how to craft an effective clinical research associate (CRA) resume, highlighting the services of BestResumeHelp.com which includes industry expertise, customization, keyword optimization, and professional formatting to showcase a CRA's qualifications and help secure new career opportunities in clinical research. The process involves placing an order, collaborating with resume experts, reviewing drafts and making revisions, and receiving the finalized resume. Key skills and responsibilities for CRAs include ensuring regulatory compliance, protocol adherence, data accuracy, and subject safety across clinical trials.
This document contains the resume of Nidhi Rai. It summarizes her educational background including an M.Sc. in Clinical Research from ICRI Bangalore and B.Sc. in Biotechnology. Her work experience includes over 5 years of experience as a Clinical Research Associate and Centralized Monitoring Lead at Quintiles Pvt Ltd, Karmic Lifesciences LLP, CliniRx Pvt Ltd, and Panacea Biotech Pvt Ltd. Her therapeutic areas of experience include psychiatry, endocrinology, vaccines, and cardiovascular disease. She has experience in monitoring visits, source data verification, query resolution, regulatory submissions, and study management.
Altasciences Clinical Research offers comprehensive Phase I/II drug development services including clinical trials, bioanalysis, data management, biostatistics, and regulatory support. They have facilities in the US and Canada with over 600 beds and can rapidly recruit from a database of over 225,000 volunteers. Altasciences is committed to quality, safety, and compliance in conducting clinical trials to help customers develop new drugs.
This document provides an overview of the clinical trial services offered by inVentiv Health Clinical, including: Phase I-IIA services conducted in their dedicated clinical facility; Phase IIB-III services including biostatistics and project management; Late Stage services such as post-marketing studies and risk evaluation; strategic resourcing capabilities including functional service providers; bioanalytical laboratory services with over 1,000 validated assays; quality assurance auditing to ensure regulatory compliance; consulting expertise in areas such as regulatory services and clinical development; therapeutic expertise across key areas like oncology and neuroscience; and a global network of over 7,000 employees in 36 countries.
KWS BioTest is an immunology CRO that offers a range of validated in vitro and in vivo models for immuno-oncology, autoimmune disease, inflammation, allergy, and anti-microbials/anti-virals. Led by an expert CSO and highly trained staff, KWS BioTest works with clients to design cost-effective preclinical and clinical research programs through customized assay development and interpretation of results to facilitate critical decision making. Services include cell biology, bioanalytical assays, clinical biomarkers, in vivo studies, and vaccine development. KWS BioTest prides itself on providing flexible, bespoke solutions to meet clients' individual research needs.
2014 Avoca Industry Report Executive Summary The Avoca Group
The document discusses a 2014 report from Avoca Group on the use of "intelligent" or data-driven approaches in clinical development. It found that both sponsors and providers apply these approaches most frequently to region and site selection. Providers reported greater advancement than sponsors in applying intelligent approaches across various clinical trial activities over the past two years. Sponsors viewed providers as making the most significant contributions to intelligent approaches for site selection, region selection, monitoring, and patient recruitment.
Clino-Vision is an institute dedicated to promoting ethical clinical research and education. It offers various clinical research programs and training to prepare professionals for the evolving industry. Clino-Vision also provides site management services to support clinical trials for pharmaceutical and medical device companies. Its vision is to be a global leader in clinical research knowledge and serve the industry to benefit social well-being.
Altasciences Clinical Research offers comprehensive Phase I/II drug development services including clinical trials, bioanalysis, data management, biostatistics, and regulatory support. They have facilities in the US and Canada with over 600 beds and can rapidly recruit from a database of over 225,000 volunteers. Altasciences focuses on customized solutions and meeting timelines to provide value to their pharmaceutical and biotech customers.
Efficient PHP Development Solutions for Dynamic Web ApplicationsHarwinder Singh
Unlock the full potential of your web projects with our expert PHP development solutions. From robust backend systems to dynamic front-end interfaces, we deliver scalable, secure, and high-performance applications tailored to your needs. Trust our skilled team to transform your ideas into reality with custom PHP programming, ensuring seamless functionality and a superior user experience.
The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
Adani Group's Active Interest In Increasing Its Presence in the Cement Manufa...Adani case
Time and again, the business group has taken up new business ventures, each of which has allowed it to expand its horizons further and reach new heights. Even amidst the Adani CBI Investigation, the firm has always focused on improving its cement business.
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Unlocking WhatsApp Marketing with HubSpot: Integrating Messaging into Your Ma...Niswey
50 million companies worldwide leverage WhatsApp as a key marketing channel. You may have considered adding it to your marketing mix, or probably already driving impressive conversions with WhatsApp.
But wait. What happens when you fully integrate your WhatsApp campaigns with HubSpot?
That's exactly what we explored in this session.
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1. Local Solutions to global challenges
Sovereign Health is a Clinical Trial Management
Our mission is to Conduct Organization, managing clinical trials across the
Studies that conform to the globe with compliance to ICH-GCP providing clinical
trial support to Pharmaceutical and Biotechnology
highest level of quality, companies and Clinical Research Organizations
compliance, ethical standards (CROs) worldwide.
and patient care. Sovereign Health was established in 2006 to
improve the capability of the site level service required
for running high quality ICH-GCP clinical trials. This
Why Sovereign Health was a response to the demands of global
Dedicated clinical research sites under one
? pharmaceutical companies for conducting
management multinational trials that include India. Sovereign owns
? of sites trained to international standards
Network and operates its own dedicated clinical research
? therapeutic experience
In-depth, sites, as well as provides sites and investigators
Innovative leadership
?
assistance in conducting clinical studies conforming
Comprehensive training & development
?
to ICH GCP guidelines to ensure accuracy,
Local leadership of key opinion leaders
?
authenticity and consistency of quality of clinical data
Centralized systems and infrastructure
?
generated.
Centralized training and project management,
?
Standardized SOPs and QA processes
? Our sites are in locations covering a wide and
Extensive experience in CNS studies
? heterogeneous mix of population. This is the first
Comprehensive training in standard operating
? network of its kind in India to help provide the fastest
procedures
patient recruitment and specialty areas for clinical
High recruitment and retention
?
research in Phase II to phase IV studies. We are
Large database of patients
?
fortunate to have with us Principal Investigators who
GCP Compliance
?
represent some of India's best clinicians and
Knowledge of local and global regulations
?
researchers and are key opinion leaders in their fields
? in local regulatory standards
Expertise
Capabilities in Regulatory Affairs
?
of expertise.
Capabilities in Project Management
?
Sovereign Health's specialist focus in central
Data quality of international standards
?
management policy means all sites benefit from
Centralized infrastructure with data generation
?
capabilities of international standards the same high standards of infrastructure and
Fully bilingual staff
? quality control systems as well as regular
Local expertise
? centralized training for site staff and
? Offices
4 global investigators.
Integrating with your organisation for better results
2. Project Management
At Sovereign a High Calibre Clinical Research Team
well known for pro activeness, professionalism and
quality in the field works in partnership with clients to
ensure that the project is effectively and efficiently
managed.
Every project is assigned to a Project Manager who
is experienced in all aspects of handling a successful
clinical project in accordance to ICH/GCP, local
regulations and SOPs. We utilize a team-oriented
approach, leveraging the years of experience that
each member has, along every step of the process,
thereby providing the client with a high quality
service, at the same time ensuring that all timelines
are strictly adhered to.
Providing innovative leadership the project managers
serve as a primary resource and a single point of
communication for the different projects. Through
meticulous planning and co-ordination, the team strives
to deliver projects with a clear focus on providing quality
backed by on-time and on-cost deliverables.
The team provides dedicated and well equipped
clinical research sites spread all across India for
carrying out Sponsor clinical trial and trains, certify
and position clinical research coordinators at the
sites to assist the investigator in conduct study as per
protocol.
Site Management
Sovereign Health upholds stringent standards to ensure adequate protection of the rights and safety of all
subjects involved in clinical investigations. We offer complete Site Management Services across the country,
delivered through a highly experienced team. To support the work of principal investigators and sub-
investigators trained and qualified coordinators are positioned at the site.
Investigator Services
We identify appropriate investigators and continually nurture relationships throughout the study to ensure the
timely, cost-effective success of clinical trial. From recruitment, to essential documents, to agreements and
budgets to investigator meetings, to grants management, the Investigator Services staff assigned to the project
Your partner in making studies successful.
3. provides comprehensive services. The
What makes Sovereign Health Different?
clear, continual communication with a single
Extensive Database of Investigators and study staff
? point-of-contact is the key to our strong
? Centralized Services
Providing relationships with investigators. Our
? Monitoring
Internal extensive database of experienced
Client satisfaction
? investigators provides access for a quick
Customer Support
?
study initiation within stipulated timeframe.
Regulatory Consultancy
The Regulatory Affairs Department at Sovereign is geared to provide the most effective regulatory assessment
and strategy for timely submission and early approval. Our pharmaceutical regulatory consultant services offer
the best solutions to meet all kinds of challenges for pharmaceutical, biotechnology, diagnostics and CRO
industries.
Sovereign provides regulatory consulting as a customized stand-alone service or through our full service
clinical trials. Our regulatory professionals ensure client satisfaction through streamlined procedures that
provide rapid turnaround of tasks, enabling faster start up and compliance with applicable guidelines.
Quality Assurance Services
Sovereign's quality assurance and quality control systems aim to
ensure high quality performance throughout the entire study period.
The Quality Assurance department follows an independent,
planned, systemic, ongoing quality assessment program focusing
on management and organizational performance to ensure
excellence in delivery to our sponsors. Self-check systems are in
As part of the
place to provide improvement and control of quality in management Cognition Group,
of clinical studies.
Sovereign Health has
Quality Assurance has established systems and processes to
ensure that clinical work is performed and data are produced in
inherited the expertise
compliance with all applicable regulations, guidelines, sponsor and of conducting CNS
clients' SOPs, Client contracts. Our experienced quality assurance
professionals work with our clients to conduct internal and external clinical trials in over
GCP auditing. All studies performed are audited by our Quality 40 countries
Assurance and Compliance Department according to FDA
regulations and ICH-GCP guidelines. Audits are conducted
according to Sponsor/ CRO SOPs, and client contracts. SOPs are
rigorously followed and in-service training is attended by all the site
personnel on a regular basis to guarantee the highest quality and
compliance with ICH-GCP guidelines
Dedicated and competent Project Management Team.
4. Co-ordination of Study kick-off and Investigator Meetings
An Investigator meeting coordinated by Sovereign is geared towards
creating a dynamic environment for the interaction of individuals with a
common purpose. These interactive meetings are designed to be both
informative and thought provoking and enable investigators to develop a
dialogue with sponsors on best practices for gathering clinical trial data.
Additional The meetings also include training in key areas including trial protocol,
Services current Good Clinical Practice and study-specific procedures. From
scientific presentations to program management, meeting services,
Pharmacovigilance and Safety
?
creative design and production, Sovereign aims to conduct meetings
Monitoring that are engaging, dynamic and effective
? Trial Supply
Clinical Training
Management
Centralized and continuous training are key features at Sovereign
Document Reviews and
? Health sites. Every member is given a comprehensive induction. Their
Translations of Study individual training needs are assessed and training is provided on
Documents
continuous basis. Our team has the expertise to conduct ICH GCP
? and Research Writing
Medical training and workshops for clinical research professionals. Prior to
Study Monitoring
?
initiating trials, we ensure that all investigators and site personnel are
well trained in GCP and any training that is protocol specific.
? and Local Laboratory
Central
Services Data Management
Drug Importation and
? Sovereign offers cost-effective Data Management solutions customized
Accountability to meet the requirements of clients. The Project Management teams
work closely with the clients and act as the custodians of timelines and
Investigational Product
?
Management using a state-of- responsibilities through all phases of the project
the-art Central Pharmacy
The Group provides secure electronic data capture (EDC) and near real
? Services
Courier
time web reporting as well as data management, statistical analysis
services. The unique web-based reporting system allows access to data
in near real time. The data is available to viewing immediately after it is
uploaded into a customized database. Interim data reports are provided
and data queries are raised throughout the trial. The data management
team utilizes the software Microsoft SQL Server 2000/2005, Extensible
Markup Language, Active Server Pages, SAS/SPSS.
Sovereign Health India Pvt. Ltd.
India Office : SCO - 28, IIIrd Floor, Sector - 14, Gurgaon - 122 001 (Haryana)
Tel: 91 124 4166 400 Fax: 91 124 4166 449
US Office : 254 Chapman Road, Topkis Building, Suite 100, Newark, DE 19702
Tel: +1-302-454-1265 Fax: +1-302-454-7868
UK Office : Twisleton Court, Priory Hill Dartford, Kent Da1 2EN
Tel: +44-1322-286 862 Fax: +44-1322-319271
www.sovhealthindia.com