Cloud-based MDM is cost-effective and easily implemented; it is scalable, robust and mature; and it has the flexibility required to enable and support the evolving transformation of life sciences commercial operations.
Almost 440 companies have completed the CONNECT Springboard accelerator program since 2005. More than 290 alumni have raised over $1.6 billion in capital. Nearly 20 percent of alumni have undergone liquidity events such as acquisitions or IPOs. As of 2016, over 250 Springboard graduates were still actively in business, with alumni companies creating more than 6,000 jobs. The accelerator focuses on tech, life sciences and consumer products companies, helping entrepreneurs refine their pitch and commercialization strategy.
ValGenesis Case Study With Scinopharm -Paperless Validation Software Solution ValGenesis
ValGenesis delivered a validated and qualified system in six weeks – the rapid implementation we needed. The system has been stable from the start, with little need for customer support calls, allowing us to focus on training and bringing on new users every week.”
— Steve Johnson, Director, Operations
Injectable Facility
ScinoPharm Taiwan, Ltd.
This document discusses challenges for e-health development in emerging countries like Turkey, Saudi Arabia, UAE, and Egypt based on interviews with healthcare professionals. It finds that key challenges include lack of ICT infrastructure, unclear regulations, difficulties financing systems, ineffective supply chain management, lack of cultural adaptation among users, and lack of trust/privacy protections for big data in digital health systems. Addressing these challenges is important for successful e-health implementation and utilization, especially in developing countries where resources and stability can be limited.
The document provides an overview of Vishuo Biomedical's final marketing presentation for their personalized medicine platform iCMDB. It introduces the team members and describes iCMDB as a genomic sequencing analysis platform that delivers personalized medicine through genome understanding. It then discusses key drivers in personal genomics, the industry players, and positions Vishuo as a Singapore-based healthcare technology company focused on personalized medicine through genomic analysis. The presentation outlines Vishuo's expansion strategy in Asia Pacific markets, identifies target countries, and proposes a marketing mix approach including distribution channels and pricing strategies to penetrate these new markets.
The Laboratory Analytical and Life Science Instrument Industries: Looking Ahe...Bill Kelly
We take a look at the market hotspots to watch in 2018 for the Laboratory Analytical and Life Science Instrument Industries by giving you an overview of the market by the numbers and highlight specific industries including spectroscopy, chromatography, diagnostics, and laboratory software.
The power of a digital thread in life sciencesaccenture
This document discusses how a digital thread can help accelerate drug development and manufacturing processes in the life sciences industry. It highlights how orthodoxies around discovery, clinical trials, and manufacturing have been dispelled due to COVID-19. A digital solution is proposed to create better collaboration and faster decision making across R&D and manufacturing. An example is provided of how a biopharma client leveraged existing IT platforms to create a digital product profile and digitize manufacturing controls, reducing tech transfer efforts by over 20%. The benefits of the digital thread include rapid drug discovery, smart manufacturing, holistic data views, and treatments reaching more patients faster.
The document discusses primary healthcare (PHC) models and their associated outcomes based on various studies. It identifies 4 common PHC models from industrialized countries - professional, community, professional coordination, and professional contact models. A study in Quebec identified 6 PHC organization models. Different models are associated with varying effects on outcomes like quality, responsiveness, equity, accessibility, and continuity. No single model performs best or worst on all outcomes. Combining elements of different models may achieve desired effects.
Opportunities and Challenges Associated with Novel Companion Diagnostic Techn...L.E.K. Consulting
L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.
Almost 440 companies have completed the CONNECT Springboard accelerator program since 2005. More than 290 alumni have raised over $1.6 billion in capital. Nearly 20 percent of alumni have undergone liquidity events such as acquisitions or IPOs. As of 2016, over 250 Springboard graduates were still actively in business, with alumni companies creating more than 6,000 jobs. The accelerator focuses on tech, life sciences and consumer products companies, helping entrepreneurs refine their pitch and commercialization strategy.
ValGenesis Case Study With Scinopharm -Paperless Validation Software Solution ValGenesis
ValGenesis delivered a validated and qualified system in six weeks – the rapid implementation we needed. The system has been stable from the start, with little need for customer support calls, allowing us to focus on training and bringing on new users every week.”
— Steve Johnson, Director, Operations
Injectable Facility
ScinoPharm Taiwan, Ltd.
This document discusses challenges for e-health development in emerging countries like Turkey, Saudi Arabia, UAE, and Egypt based on interviews with healthcare professionals. It finds that key challenges include lack of ICT infrastructure, unclear regulations, difficulties financing systems, ineffective supply chain management, lack of cultural adaptation among users, and lack of trust/privacy protections for big data in digital health systems. Addressing these challenges is important for successful e-health implementation and utilization, especially in developing countries where resources and stability can be limited.
The document provides an overview of Vishuo Biomedical's final marketing presentation for their personalized medicine platform iCMDB. It introduces the team members and describes iCMDB as a genomic sequencing analysis platform that delivers personalized medicine through genome understanding. It then discusses key drivers in personal genomics, the industry players, and positions Vishuo as a Singapore-based healthcare technology company focused on personalized medicine through genomic analysis. The presentation outlines Vishuo's expansion strategy in Asia Pacific markets, identifies target countries, and proposes a marketing mix approach including distribution channels and pricing strategies to penetrate these new markets.
The Laboratory Analytical and Life Science Instrument Industries: Looking Ahe...Bill Kelly
We take a look at the market hotspots to watch in 2018 for the Laboratory Analytical and Life Science Instrument Industries by giving you an overview of the market by the numbers and highlight specific industries including spectroscopy, chromatography, diagnostics, and laboratory software.
The power of a digital thread in life sciencesaccenture
This document discusses how a digital thread can help accelerate drug development and manufacturing processes in the life sciences industry. It highlights how orthodoxies around discovery, clinical trials, and manufacturing have been dispelled due to COVID-19. A digital solution is proposed to create better collaboration and faster decision making across R&D and manufacturing. An example is provided of how a biopharma client leveraged existing IT platforms to create a digital product profile and digitize manufacturing controls, reducing tech transfer efforts by over 20%. The benefits of the digital thread include rapid drug discovery, smart manufacturing, holistic data views, and treatments reaching more patients faster.
The document discusses primary healthcare (PHC) models and their associated outcomes based on various studies. It identifies 4 common PHC models from industrialized countries - professional, community, professional coordination, and professional contact models. A study in Quebec identified 6 PHC organization models. Different models are associated with varying effects on outcomes like quality, responsiveness, equity, accessibility, and continuity. No single model performs best or worst on all outcomes. Combining elements of different models may achieve desired effects.
Opportunities and Challenges Associated with Novel Companion Diagnostic Techn...L.E.K. Consulting
L.E.K. Managing Director Alex Vadas spoke at a BDA workshop on "How to Mature Emerging Technologies into Companion Diagnostics?" See his presentation here.
ScienceCloud: Collaborative Workflows in Biologics R&DBIOVIA
The life sciences industry has undergone dramatic changes and effective global collaboration has become a key success factor in this new age. BIOVIA is providing a hosted and comprehensive solution stack for externalized, collaborative research for pharma/biotech and CROs to address these new challenges. Recently we added the support for biologics data management and IP capture. In this talk we will present collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze, annotate and predict developability as part of a framework that facilitates secure data sharing and collaboration.
The Industry’s Move Toward Digitally Connected Clinical TrialsVeeva Systems
The rapid adoption of decentralized trials is causing significant challenges – sites are burdened by too many technologies and the use of multiple patient-facing applications adds complexity for patients.
In these slides, we discuss the implications of decentralized trials, share findings from the Veeva Digital Clinical Trials Survey, and explore how clinical leaders are accelerating digital transformation to make studies more site and patient-centric.
Access the Veeva Digital Clinical Trials Survey Report (https://bit.ly/35eAeDn) for additional insights from more than 280 clinical leaders worldwide on the industry’s progress toward digital trial strategies, lessons learned, and what lies ahead.
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
This document discusses the benefits of integrating IRT and EDC systems from different vendors. It provides an example of Cara Therapeutics using integrated IRT and EDC systems to simplify their complex clinical trial for chronic kidney disease associated pruritus. Key benefits highlighted include reducing complexity, improving efficiency, mitigating risks, and better reporting through leveraging the expertise of both system providers and a pre-defined integration. Looking ahead, the document discusses the potential for more automated two-way integrations between IRT and EDC systems.
Many of the major disruptions in media and communications have been driven by nimble, entrepreneurial companies, coming out of nowhere to completely decimate established business models. Companies that spin into existence to solve one problem or commercialize a single idea can scale almost instantly if they find a solution that sticks. That’s what’s happening all over the marketing industry today: hundreds of tech-savvy startups are reinventing business from the bottom up.
AstraZeneca: A Vision for a Collaborative Clinical EnvironmentVeeva Systems
Slides from AstraZeneca's 2019 Veeva R&D Summit presentation.
After receiving the 2018 Eagle Award for the best sponsor by the Society for Clinical Research Sites (SCRS), AstraZeneca is on an ongoing quest to remain a sponsor of choice for 2019 and beyond. Learn how they are leveraging technology, a unified clinical trial platform, and other strategies to simplify trial conduct at sites.
Steps to Overcome Information Overload in Clinical ResearchVeeva Systems
See slides from Veeva's Outsourcing Clinical Trials West Coast presentation.
This deck explores the driving forces behind the industrywide move to streamline information exchange in clinical trials. Learn about modern technologies that improve how organizations work together across the clinical environment and discover new approaches to sharing trial information with study partners.
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
This document discusses technology-enabled global harmonization of safety reporting using local laws. It summarizes Roche's experience developing the Clinical Trial Safety Portal (CTSP) to address the challenges of differing safety reporting rules across countries. Key points include: (1) CTSP allows sites to set preferences according to local laws while providing a standardized global process, (2) It reduces costs and burden on sites by consolidating safety documents and automating distribution, (3) Roche estimates the system saved over $80 million in the first year through increased compliance and reduced workload.
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
mHealth Israel_Growth Opportunities in Clinical Trial Execution_Craig LipsetLevi Shapiro
Craig Lipsent, former Worldwide Head of Clinical Innovation at Pfizer, presents to the mHealth Israel Community, Feb, 2020. Theme: Clinical trials are vital for developing new medicines but they are broken. Clinical trial trends include the increasing attention and investment in participant & investigator experience
Digitization and innovative data capture. Forecast for clinical trials will be decentralized, distributed, democratized and disruptive.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
This document discusses the evolution of pharmacovigilance (PV) and the need for a unified safety platform to address current challenges. It notes that PV currently focuses on compliance but lacks agility and innovation. There is also low technology maturity and high manual effort. Looking ahead to 2030, the role of safety will need to be reimagined to integrate more data sources, enhance patient involvement, and support predictive and personalized treatments. A unified safety system on a cloud platform could help by integrating data from across the product lifecycle, streamlining processes, and enabling greater collaboration.
AI in Clinical Trials: From Big Sky to Practical ApplicationVeeva Systems
See presentation slides from SCOPE Summit 2020.
Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. See this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.
Webinar: Enabling Closed-loop Training Compliance for Life SciencesVeeva Systems
To watch the on-demand webinar associated with this presentation, please visit: https://go.veeva.com/closed-loop-training-compliance-registration
Efficiently managing GxP training content through a unified learning management system (LMS) is crucial to meet global compliance for life sciences companies. But legacy approaches and disparate technologies prevent them from doing so.
Today, many biopharma companies use one system to manage training and the other to manage standard operating procedures (SOPs), policies, work instructions, and other critical documents. These disconnected environments require extensive configuration and integration, reducing compliance visibility, and creating a barrier between content creation and consumption.
In this webinar, John Constantine, SVP of Talent Solutions at Orchestrall, and Kent Malmros, Senior Director of Vault Training at Veeva Systems, will discuss why many life sciences companies are modernizing learning management with a unified training platform. They will share how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance.
By attending this webinar, you will learn:
How to address common challenges in building an effective GxP training program
Best practices of creating an enterprise-wide learning strategy
How a unified GxP training environment delivers better training and quality outcomes
Who Will Benefit
Director/Manager of Quality Training
Compliance Training Manager/Director
Compliance Policy and Training, Manager/Director
Director/Manager, QA Training
Document Control and Training Manager
VP/Director of Quality and Compliance (QA or QC), Quality Systems
VP/Director of Information Technology, Quality Management Systems, Quality Systems
VP/Director Clinical Operations
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
IT has become increasingly complex and difficult to manage
and scale. Costs are growing at unprecedented rates, as
enterprises continue to add technologies in response to an
explosion in the quantity and new types of data. This explosion in data and the patchwork of methods used to store, retrieve
and provide usable views has resulted in inefficiencies in data center architecture, duplication of data base licenses, increased costs for data storage and management, and inefficient use of data center technicians. Database replication alone has precipitated new challenges and resulted in the lack of consolidation
of numerous software middleware licenses, further increasing costs.
This document discusses important aspects to consider when evaluating master data management (MDM) technologies. It emphasizes that an ideal MDM solution should have a flexible data model that can be adapted to the business rather than forcing the business to adapt to a rigid model. It also stresses the importance of proactive data governance capabilities. The document outlines eight key aspects that should be evaluated, including whether the solution allows for flexible semantic data modeling to handle business complexity and provides business users with active control over shared data across systems.
ScienceCloud: Collaborative Workflows in Biologics R&DBIOVIA
The life sciences industry has undergone dramatic changes and effective global collaboration has become a key success factor in this new age. BIOVIA is providing a hosted and comprehensive solution stack for externalized, collaborative research for pharma/biotech and CROs to address these new challenges. Recently we added the support for biologics data management and IP capture. In this talk we will present collaborative and comprehensive capabilities in antibody characterization and development: capabilities to analyze, annotate and predict developability as part of a framework that facilitates secure data sharing and collaboration.
The Industry’s Move Toward Digitally Connected Clinical TrialsVeeva Systems
The rapid adoption of decentralized trials is causing significant challenges – sites are burdened by too many technologies and the use of multiple patient-facing applications adds complexity for patients.
In these slides, we discuss the implications of decentralized trials, share findings from the Veeva Digital Clinical Trials Survey, and explore how clinical leaders are accelerating digital transformation to make studies more site and patient-centric.
Access the Veeva Digital Clinical Trials Survey Report (https://bit.ly/35eAeDn) for additional insights from more than 280 clinical leaders worldwide on the industry’s progress toward digital trial strategies, lessons learned, and what lies ahead.
The Benefits of a Seamless IRT and EDC Integration in Clinical Trial ExecutionVeeva Systems
This document discusses the benefits of integrating IRT and EDC systems from different vendors. It provides an example of Cara Therapeutics using integrated IRT and EDC systems to simplify their complex clinical trial for chronic kidney disease associated pruritus. Key benefits highlighted include reducing complexity, improving efficiency, mitigating risks, and better reporting through leveraging the expertise of both system providers and a pre-defined integration. Looking ahead, the document discusses the potential for more automated two-way integrations between IRT and EDC systems.
Many of the major disruptions in media and communications have been driven by nimble, entrepreneurial companies, coming out of nowhere to completely decimate established business models. Companies that spin into existence to solve one problem or commercialize a single idea can scale almost instantly if they find a solution that sticks. That’s what’s happening all over the marketing industry today: hundreds of tech-savvy startups are reinventing business from the bottom up.
AstraZeneca: A Vision for a Collaborative Clinical EnvironmentVeeva Systems
Slides from AstraZeneca's 2019 Veeva R&D Summit presentation.
After receiving the 2018 Eagle Award for the best sponsor by the Society for Clinical Research Sites (SCRS), AstraZeneca is on an ongoing quest to remain a sponsor of choice for 2019 and beyond. Learn how they are leveraging technology, a unified clinical trial platform, and other strategies to simplify trial conduct at sites.
Steps to Overcome Information Overload in Clinical ResearchVeeva Systems
See slides from Veeva's Outsourcing Clinical Trials West Coast presentation.
This deck explores the driving forces behind the industrywide move to streamline information exchange in clinical trials. Learn about modern technologies that improve how organizations work together across the clinical environment and discover new approaches to sharing trial information with study partners.
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
Clinlogix - Improving Pharmacovigilance Outsourcing with Modern Technologies Veeva Systems
Learn how pharma companies and vendors are collaborating and simplifying processes with modern safety solutions. View the on-demand webinar here: https://bit.ly/30eAlJC
This document discusses technology-enabled global harmonization of safety reporting using local laws. It summarizes Roche's experience developing the Clinical Trial Safety Portal (CTSP) to address the challenges of differing safety reporting rules across countries. Key points include: (1) CTSP allows sites to set preferences according to local laws while providing a standardized global process, (2) It reduces costs and burden on sites by consolidating safety documents and automating distribution, (3) Roche estimates the system saved over $80 million in the first year through increased compliance and reduced workload.
Best practices for implementing and maintaining successful standardsVeeva Systems
Watch the video here: https://bit.ly/3uvar1u
This webinar provides best practices, check-lists and case studies for leveraging standards in clinical trials. From creation and implementation, to governance tools (both internal and with external partners), attendees walk away with actionable insights to leverage with their own organization.
* Understand what to standardize
* Learn several approaches to standards development and when they make sense
* Ensure alignment with key stakeholders
* Maintain and govern standards over time
* Reduce overall configuration time
Who Will Benefit:
* Clinical Data (manager/director/head of) Clinical ops
* Data management
* Biostatistics
* Data science
* Clinical science
* EDC
* Biometrics
* eClinical
* Data standards
* Quantitative sciences
* Informatics
* Data monitoring
* Clinical leads
* Study managers
* Clinical study
* Data manager
* CRA
* CDISC
Meet Your Presenters:
Carla Reis
Director, Client Services, 4G Clinical
Carla Reis, Director of Client Services at 4G Clinical, has over 18 years of experience as an operational leader in developing and implementing RTSM systems in a global pharmaceutical company. Carla was a leader in her organization in establishing vendor management standards and processes. She has helped lead major RTSM process improvement initiatives where she established new and innovated approaches to drug assignment verification and vendor integrations. Carla has presented at industry conferences as a subject matter expert on best practices using RTSM solutions for complex strategies in supply chain management. Carla holds a BS in Neurobiology and Physiology from the University of Connecticut and a certification as Lean Six Sigma Yellow Belt. Carla also holds a Masters in Science in Health Administration with a concentration in Health Informatics from Saint Joseph's University.
Paul MacDonald
Senior Director, Strategy Vault CDMS, Veeva Systems
Paul is Senior Director Vault CDMS, responsible for strategy and direction in data management. With 25+ years experience working in life science at pharma, CRO and technology organisations, Paul brings a strong operational focus in relation to eClinical technology for data management and clinical operations that stretches from EDC, through CTMS to risk based monitoring.
mHealth Israel_Growth Opportunities in Clinical Trial Execution_Craig LipsetLevi Shapiro
Craig Lipsent, former Worldwide Head of Clinical Innovation at Pfizer, presents to the mHealth Israel Community, Feb, 2020. Theme: Clinical trials are vital for developing new medicines but they are broken. Clinical trial trends include the increasing attention and investment in participant & investigator experience
Digitization and innovative data capture. Forecast for clinical trials will be decentralized, distributed, democratized and disruptive.
Building a Foundation for Proactive and Predictive PharmacovigilanceVeeva Systems
Learn how PV teams can easily keep up with evolving compliance requirements with modern safety applications that provide better data control and drive greater efficiencies.
View on-demand session: https://bit.ly/3vIzQG9
PICI’s Best Practices for Building Oncology Studies in an EDCVeeva Systems
Watch the video here: https://bit.ly/3vrYslR
The Parker Institute for Cancer Immunotherapy (PICI) runs complex clinical trials that depend on an electronic data capture (EDC) system that is adaptive, flexible and innovating at the same pace as their patient-centric mission.
Learn why their legacy EDC system workarounds and custom functions no longer sustained their business, which motivated them to take a new approach. In this webinar, Toby Odenheim, the Director of Technology and Governance, will share how PICI decided to adopt a new EDC system that streamlines the build process for oncology trials and how they better equip their clinical programmers and data managers. PICI’s lead study builder, Gary Smith, will provide a hands-on perspective and share strategies to handle the key challenges that oncology teams face with EDC systems, including:
* Umbrella trials that evaluate multiple therapies
* Adaptive trial branching and routing
* Having an unknown number of treatment cycles
* Amendments and other unplanned changes
Who Will Benefit:
* Data managers
* Database Programmers
* Clinical Programmers
* Clinical programmers in charge of building studies
* Clinical leaders in charge of selecting EDC systems
* EDC Programmers
Meet Your Presenters:
Toby Odenheim
Director, Technology and Governance, Parker Institute for Cancer Immunotherapy
In his current role as director of technology and governance at PICI, Toby Odenheim, MBA, leads an array of technology and process improvement initiatives aimed at accelerating the development of innovative cancer immunotherapy treatments. Core areas of oversight include management of clinical and pharmacovigilance systems, including CTMS, eTMF, IRT, EDC, ePRO, medical coding, safety, and business intelligence systems.
Prior to joining PICI, Odenheim was the founder and principal at Odin Life Sciences Consulting, where he guided companies in the selection, implementation, and validation of best-of-breed clinical technologies. Toby Odenheim has held management positions at Gilead, Synteract, ClinicalSoft, and Pfizer. He holds an undergraduate degree in biology, an MBA, and professional certifications in finance, Oracle database administration, and relational database design.
Gary Smith
Senior EDC Programmer/Analyst, Parker Institute for Cancer Immunotherapy
Gary has over twenty years of experience in clinical programming and is a subject matter expert on study design, configuration, and testing with off-the-shelf EDC systems including Veeva Vault CDMS, Medidata Rave, and Oracle Clinical. Gary has deep expertise in building oncology studies, specifically platform studies, and is currently responsible for all aspects of EDC design and study builds in immuno-oncology studies with the Parker Institute for Cancer Immunotherapy. Gary has developed global libraries for five different companies, spanning medical device and pharmaceutical industries.
Reimagine patient safety 2030 governance through a unified safety platformVeeva Systems
This document discusses the evolution of pharmacovigilance (PV) and the need for a unified safety platform to address current challenges. It notes that PV currently focuses on compliance but lacks agility and innovation. There is also low technology maturity and high manual effort. Looking ahead to 2030, the role of safety will need to be reimagined to integrate more data sources, enhance patient involvement, and support predictive and personalized treatments. A unified safety system on a cloud platform could help by integrating data from across the product lifecycle, streamlining processes, and enabling greater collaboration.
AI in Clinical Trials: From Big Sky to Practical ApplicationVeeva Systems
See presentation slides from SCOPE Summit 2020.
Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. See this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.
Webinar: Enabling Closed-loop Training Compliance for Life SciencesVeeva Systems
To watch the on-demand webinar associated with this presentation, please visit: https://go.veeva.com/closed-loop-training-compliance-registration
Efficiently managing GxP training content through a unified learning management system (LMS) is crucial to meet global compliance for life sciences companies. But legacy approaches and disparate technologies prevent them from doing so.
Today, many biopharma companies use one system to manage training and the other to manage standard operating procedures (SOPs), policies, work instructions, and other critical documents. These disconnected environments require extensive configuration and integration, reducing compliance visibility, and creating a barrier between content creation and consumption.
In this webinar, John Constantine, SVP of Talent Solutions at Orchestrall, and Kent Malmros, Senior Director of Vault Training at Veeva Systems, will discuss why many life sciences companies are modernizing learning management with a unified training platform. They will share how unifying document management and training in a single platform ensures the traceability of training materials from creation to consumption, enabling closed-loop compliance.
By attending this webinar, you will learn:
How to address common challenges in building an effective GxP training program
Best practices of creating an enterprise-wide learning strategy
How a unified GxP training environment delivers better training and quality outcomes
Who Will Benefit
Director/Manager of Quality Training
Compliance Training Manager/Director
Compliance Policy and Training, Manager/Director
Director/Manager, QA Training
Document Control and Training Manager
VP/Director of Quality and Compliance (QA or QC), Quality Systems
VP/Director of Information Technology, Quality Management Systems, Quality Systems
VP/Director Clinical Operations
Unify quality manufacturing to drive speed, compliance and collaborationVeeva Systems
Whether you are an emerging CDMO looking to scale and attract sponsors or an established generics org looking to transform legacy systems, there is an approach to consider! Learn how you can drive efficiency, collaboration, and compliance and how to get started in unifying your quality manufacturing processes.
IT has become increasingly complex and difficult to manage
and scale. Costs are growing at unprecedented rates, as
enterprises continue to add technologies in response to an
explosion in the quantity and new types of data. This explosion in data and the patchwork of methods used to store, retrieve
and provide usable views has resulted in inefficiencies in data center architecture, duplication of data base licenses, increased costs for data storage and management, and inefficient use of data center technicians. Database replication alone has precipitated new challenges and resulted in the lack of consolidation
of numerous software middleware licenses, further increasing costs.
This document discusses important aspects to consider when evaluating master data management (MDM) technologies. It emphasizes that an ideal MDM solution should have a flexible data model that can be adapted to the business rather than forcing the business to adapt to a rigid model. It also stresses the importance of proactive data governance capabilities. The document outlines eight key aspects that should be evaluated, including whether the solution allows for flexible semantic data modeling to handle business complexity and provides business users with active control over shared data across systems.
Cloud-based MDM solutions provide several potential rewards over on-premise solutions, including reduced costs, faster deployment, and increased scalability. However, companies must also consider risks like privacy, security, and loss of control. It is important for companies to understand how the cloud vendor will store and manage their data before deciding if a cloud-based MDM is appropriate for their needs and risk tolerance.
Mindtree provides cloud services to help believe that digital transformation of healthcare is only possible by embracing & adopting the cloud. Click her to know more.
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This document discusses how large organizations can balance flexibility and oversight when adopting cloud technologies. While cloud offers benefits like on-demand resources and pay-as-you-go models, it can undermine IT's control if not properly governed. Effective cloud initiatives must be integrated into existing service delivery models and governance mechanisms are needed to ensure alignment with business needs over time. Key areas for governance include demand management, capacity planning, service level management, and invoice/chargeback management. Governance helps organizations maximize cloud benefits while mitigating risks.
The document discusses challenges facing distributed enterprises, including connectivity, security, manageability, and total cost of ownership. It introduces Juniper Networks' Distributed Enterprise Solutions which aim to enable IT services without boundaries across distributed locations. The solutions provide consistent connectivity, security, and management while reducing overall costs.
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For Life Sciences, the Future of Master Data Management is in the Cloud
1. • Cognizant 20-20 Insights
For Life Sciences, the Future of Master
Data Management is in the Cloud
Executive Summary Cloud Cost Savings
Life sciences commercial operations are Traditional MDM systems managed in-house are
undergoing major shifts in how they operate expensive to implement and maintain because
and in the resources available to them. Increas- they require hardware and software investments,
ingly, sales and marketing organizations will sell significant customization and ongoing mainte-
therapies targeted to smaller patient popula- nance and upgrades. The cloud model eliminates
tions, and they already have shrinking marketing as much as half of the costs of traditional MDM
budgets and less direct access to physicians. At approaches.
the same time, sales professionals are using new
and varied tools: tablet computers, smartphones According to our typical client experiences, an
and a variety of social media outlets. initial investment in an on-site MDM system costs
a mid-sized-to-large pharmaceuticals company
Smart master data management (MDM) is critical between $4 million and $10 million for hardware
to getting better results with fewer resources and software. Implementation time for such
and different tools. Mining customer data, and systems runs six months to a year. Hardware
relationships among that data, can yield valuable and software must be upgraded regularly, and
business intelligence. Yet traditional, on-prem- security measures continuously evaluated and
ises MDM systems consume vast financial and maintained. In addition, as sales teams adopt
human resources. Given the cost pressures on life mobile access devices, the MDM system must
sciences companies, traditional MDM solutions integrate with and support those devices with
are increasingly untenable. new features and services, often requiring more
programming and customization.
The time has come to put the life sciences
customer in the cloud. Life sciences companies This array of maintenance and upgrade activity,
can adopt a flexible, affordable MDM model plus the initial investment, makes ownership of an
that provides high-quality, up-to-date customer on-premises MDM system extremely expensive.
data, whenever and wherever it is required, at a The high cost is increasingly hard to justify in the
fraction of the cost of on-premises MDM invest- face of industry turmoil and constant financial
ments. Cloud-based MDM is cost-effective and constraints — especially when the cloud is such a
easily implemented; it is scalable, robust and powerful alternative to traditional MDM.
mature; and it has the flexibility required to
enable and support the evolving transformation
of life sciences commercial operations.
cognizant 20-20 insights | april 2012
2. Cloud-based MDM draws on an experienced 50% cost savings with a cloud MDM subscrip-
service provider’s economies of scale to offer tion compared with a traditional MDM solution,
these benefits: without compromising features or functions.
• Faster implementation: Cloud-based MDM is Better Support for Commercial
available to support commercial operations in Operations
four to six weeks vs. the year-long implemen-
Life sciences sales and marketing profession-
tations often required by traditional solutions.
als are still expected to improve results despite
• Upfront and continuing savings: Integration narrower development pipelines, smaller target
between the cloud and common internal appli- populations and lower budgets. Being successful in
cations should be included in the set-up, while these conditions requires commercial operations
customization is typically quicker and less to use customer data more creatively to identify
expensive because service providers draw on high-value targets, plan effective promotions
a large base of industry best practices to guide and accurately measure results. The cloud model
this work. Standard upgrades should be free. supports these new business and commercial
operations strategies by providing complete and
• Predictable operating costs: Clients subscribe current data for dynamic targeting, call planning
only to the level of service they need and do
not pay for capacity and capabilities they don’t and re-routing, measuring and analytics, all at
require. lower costs.
• Minimized data stewardship expenses: Expe- • Fast availability of cloud-based MDM solutions
rienced service providers build data quality — in weeks, not months — means these systems
assurance practices and structures into can be used with a specific, limited trial for a
their solutions so clients can reduce internal product or campaign to evaluate new branding
resources dedicated to these tasks. or product lifecycle extension strategies.
Based on our engagements, most average • Easier integration of cloud MDM with
and large life sciences companies can achieve internal applications and devices, including
Customer-in-the-Cloud
Business Process as a Service
Software as a Service
Platform as a Service
Infrastructure as a Service
Figure 1
cognizant 20-20 insights 2
3. smartphones and tablets, makes data more Powerful Tools Today;
accessible, whenever and wherever it is needed. Flexibility for the Future
• Faster updates and “anytime” access ensure Cloud solutions will give life sciences commercial
that cloud data is fully current and accurate for operations the flexibility and capabilities required
all users and applications. for managing ever-changing industry conditions
• Eliminating data silos through streamlined at a fraction of the time and cost associated with
integration and access enables business strat- adapting internal systems to new branding and
egists to more easily find and analyze rela- marketing strategies.
tionships among customers and groups of
Regulatory changes often require extensive
customers — potentially even extending that
system changes, making maintenance and
intelligence to users of therapies. Enabling
upgrading of on-premises solutions an expensive,
easier data mining will be important for
never-ending project. With cloud-based MDM, that
developing new strategies for defining and
burden is on the service provider. Experienced
reaching smaller target populations with
service providers with deep and wide healthcare
effective messages.
expertise typically have anticipated these shifts
Life sciences commercial operations can draw on and so are able to accommodate them quickly
these benefits from the cloud with full assurance and minimize their financial impact on service
that their customer data is secured and accessible subscribers.
only by authorized users. Experienced service
The cloud model also has the inherent flexibility
providers incorporate a comprehensive range of
to connect with other public and private clouds,
powerful security and identity management tools,
social media, mobile applications, wireless access
far beyond what most individual companies can
and evolving technologies and collaborative
afford to create and maintain.
approaches to delivering healthcare. Such inte-
MDM in the cloud is a natural extension of a gration, alongside data access, will be critical
model many life sciences companies already for supporting the increasingly blurred lines of
have adopted: cloud-based customer relationship industry entities and to reach more empowered
management (CRM) applications. Cloud CRM can and connected consumers of therapies and
be easily integrated with cloud MDM solutions, healthcare.
further streamlining the client’s data collection,
Accomplishing such technologically sophisticated
access and management.
connectivity in-house is difficult, time-consuming
Other third-party cloud-based data solutions, and expensive. Compare that approach with the
such as state license number (SLN), data cloud service provider, which can keep technology
cleansing and specialized validation services, can in alignment with a shifting industry so that life
also be quickly integrated with cloud-based MDM. sciences commercial operations can focus on
Such integration extends the savings, timeliness strategies and sales.
and accuracy of a cloud MDM implementation to
other data functions.
About the Author
Sriraj Rajaram is the North American Practice Leader for master data management in Cognizant’s
Customer Solutions Practice. He specializes in defining ROI for master data projects, establishing data
governance processes and developing MDM sponsorship within enterprises. Sriraj’s team is responsible
for many of Cognizant’s innovative MDM solutions, including MDM-in-a-Box and Customer-in-the Cloud.
He can be reached at Sriraj.Rajaram@cognizant.com.
cognizant 20-20 insights 3