Choosing an eSource System, Daniel Selness, Spaulding Clinical Research
•
1 like•306 views
This document discusses choosing an electronic source (eSource) system for clinical research. It provides an overview of the speaker, Dan Selness, and his company, Spaulding Clinical Research. The presentation covers the benefits of eSource such as increased data quality and compliance, real-time data access, and faster study timelines. It advises that when choosing a system, facilities should look for features like full validation support, scalability, and integration capabilities. The presentation predicts that eSource usage will grow significantly in coming years as studies increase in complexity and integration of technologies improves clinical research processes.
Report
Share
Report
Share
Download to read offline
Recommended
Biology - Biotechnology - Study Guide
This document is a review sheet containing questions about various topics in biotechnology including transgenic organisms, cloning, stem cells, and regenerative medicine. It asks about the process of creating transgenic organisms, the benefits and concerns of transgenic plants, the steps to make a clone, health issues clones may face, the differences between embryonic and adult stem cells, and how regenerative medicine aims to repair damaged tissues and organs.
SHS Flexim - UW Madison
This document summarizes a simulation model created to analyze different patient flow scenarios in an emergency department. Key aspects of the model include:
- The model simulates three different patient triage and treatment pathways: traditional triage, a provider in triage team (PITT) model, and a super fast track (SFT) model.
- Input data was collected from a case study of a real emergency department, literature reviews, and expert interviews to inform parameters like patient arrival patterns and lengths of stay.
- The model was built in FlexSim and incorporates details like staffing levels, pathways for different patient acuity levels, and variability in tasks like testing and treatment times.
- Output will be analyzed to compare
Cfbffd44 c79e-4c8c-bc2e-503a698cfad5-150304115917-conversion-gate01
This document summarizes a simulation model created to analyze different patient flow scenarios in an emergency department. Key aspects of the simulation include:
- The model was created using FlexSim software to analyze the current triage system and alternatives like a "provider in triage team" approach.
- Extensive input data was collected on patient arrival patterns, length of stay, acuity levels and other metrics from the case study hospital and literature to inform the model.
- The model incorporates detailed process maps and assumptions about staffing, equipment, testing, and patient movement between different areas to replicate real-world ED operations.
- Initial results will be analyzed to compare performance metrics like length of stay and door to provider
Presentation phinney abrf 2019
Not the best presentation, mostly a stream a consciousness about analyzing samples in a Core facility, although I do list some of my favorite methods. So maybe it will be useful to some? I repacakged this into a better talk (see my Genomeweb 2019 talk on SlideShare)
Clinical trials and trial data in future
Clinical trials in the future may change significantly due to advances in areas like stem cells, organ chips, and organ printing. Phase 1 trials could become mostly laboratory-based using larger data sets from rare diseases. Phase 2 trials may require fewer subjects. Safety and results could improve. Clinical data management may see Phase 1 require less data collection and amendments. Standardized data and analysis may simplify validation.
Oracle LabPas for Phase I Clinic Automation
This document provides an overview of a live demo presentation of Oracle LabPas, a clinical trial management system for phase I clinics. The presentation agenda includes introductions of the presenters, an explanation of what LabPas is and who needs it, reasons to choose LabPas, a live demo, and a question and answer section. LabPas allows organizations to automate tasks involved in phase I clinical trials like volunteer recruitment, electronic data capture, and real-time data sharing. It is intended for independent phase I clinics, clinical research organizations, academic research organizations, and pharmaceutical companies with their own phase I clinics who want to increase efficiency and compliance while reducing costs.
The Key to Success in Managing High Volumes of Samples in the Processing Lab,...
The document discusses the key to success in managing high volumes of samples in a processing lab. It outlines how Spaulding Clinical Research transitioned to using the ClinSpark electronic data capture (EDC) system and the advantages it provided. ClinSpark allowed for decreased deviations, flexible study builds, and improved sample reporting and tracking. Example studies demonstrated how ClinSpark could handle complex sample processing workflows and capture detailed data at each step.
Medical Intelligence EDW 20 juni: Radboudumc
The document discusses setting up a data warehouse and data mart architecture to integrate clinical and research data from various source systems at an academic medical center. It proposes using a data vault approach for staging, a dimensional data model for the enterprise data warehouse compliant with standards like FHIR and Star schema, and demand-driven development of data marts. The goal is to have a single integration layer and environment for both clinical and research data to improve findability, reuse, and analytics across use cases. Governance, master data management, and integration challenges are also addressed.
Recommended
Biology - Biotechnology - Study Guide
This document is a review sheet containing questions about various topics in biotechnology including transgenic organisms, cloning, stem cells, and regenerative medicine. It asks about the process of creating transgenic organisms, the benefits and concerns of transgenic plants, the steps to make a clone, health issues clones may face, the differences between embryonic and adult stem cells, and how regenerative medicine aims to repair damaged tissues and organs.
SHS Flexim - UW Madison
This document summarizes a simulation model created to analyze different patient flow scenarios in an emergency department. Key aspects of the model include:
- The model simulates three different patient triage and treatment pathways: traditional triage, a provider in triage team (PITT) model, and a super fast track (SFT) model.
- Input data was collected from a case study of a real emergency department, literature reviews, and expert interviews to inform parameters like patient arrival patterns and lengths of stay.
- The model was built in FlexSim and incorporates details like staffing levels, pathways for different patient acuity levels, and variability in tasks like testing and treatment times.
- Output will be analyzed to compare
Cfbffd44 c79e-4c8c-bc2e-503a698cfad5-150304115917-conversion-gate01
This document summarizes a simulation model created to analyze different patient flow scenarios in an emergency department. Key aspects of the simulation include:
- The model was created using FlexSim software to analyze the current triage system and alternatives like a "provider in triage team" approach.
- Extensive input data was collected on patient arrival patterns, length of stay, acuity levels and other metrics from the case study hospital and literature to inform the model.
- The model incorporates detailed process maps and assumptions about staffing, equipment, testing, and patient movement between different areas to replicate real-world ED operations.
- Initial results will be analyzed to compare performance metrics like length of stay and door to provider
Presentation phinney abrf 2019
Not the best presentation, mostly a stream a consciousness about analyzing samples in a Core facility, although I do list some of my favorite methods. So maybe it will be useful to some? I repacakged this into a better talk (see my Genomeweb 2019 talk on SlideShare)
Clinical trials and trial data in future
Clinical trials in the future may change significantly due to advances in areas like stem cells, organ chips, and organ printing. Phase 1 trials could become mostly laboratory-based using larger data sets from rare diseases. Phase 2 trials may require fewer subjects. Safety and results could improve. Clinical data management may see Phase 1 require less data collection and amendments. Standardized data and analysis may simplify validation.
Oracle LabPas for Phase I Clinic Automation
This document provides an overview of a live demo presentation of Oracle LabPas, a clinical trial management system for phase I clinics. The presentation agenda includes introductions of the presenters, an explanation of what LabPas is and who needs it, reasons to choose LabPas, a live demo, and a question and answer section. LabPas allows organizations to automate tasks involved in phase I clinical trials like volunteer recruitment, electronic data capture, and real-time data sharing. It is intended for independent phase I clinics, clinical research organizations, academic research organizations, and pharmaceutical companies with their own phase I clinics who want to increase efficiency and compliance while reducing costs.
The Key to Success in Managing High Volumes of Samples in the Processing Lab,...
The document discusses the key to success in managing high volumes of samples in a processing lab. It outlines how Spaulding Clinical Research transitioned to using the ClinSpark electronic data capture (EDC) system and the advantages it provided. ClinSpark allowed for decreased deviations, flexible study builds, and improved sample reporting and tracking. Example studies demonstrated how ClinSpark could handle complex sample processing workflows and capture detailed data at each step.
Medical Intelligence EDW 20 juni: Radboudumc
The document discusses setting up a data warehouse and data mart architecture to integrate clinical and research data from various source systems at an academic medical center. It proposes using a data vault approach for staging, a dimensional data model for the enterprise data warehouse compliant with standards like FHIR and Star schema, and demand-driven development of data marts. The goal is to have a single integration layer and environment for both clinical and research data to improve findability, reuse, and analytics across use cases. Governance, master data management, and integration challenges are also addressed.
The role of the laboratory
The document discusses the roles of public health laboratories and forensic laboratories. It describes how public health laboratories support disease investigation and outbreak response. They work with the Laboratory Response Network (LRN) to identify pathogens. Forensic laboratories assist with criminal investigations by analyzing evidence. Both types of laboratories follow strict chain of custody procedures to ensure sample integrity which is important for legal purposes. Public health laboratories are regulated at the state level while forensic laboratories work with law enforcement and medical examiners.
Activities at the Royal Society of Chemistry to gather, extract and analyze b...
Activities at the Royal Society of Chemistry to gather, extract and analyze b...US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
The phrase “Big Data” is generally used to describe a large volume of structured and/or unstructured data that cannot be processed using traditional database and software techniques. In the domain of chemistry the Royal Society of Chemistry certainly hosts large structured databases of chemistry data, for example ChemSpider, as well as unstructured content, in the form of our collection of scientific articles. Our research literature provides value to their readership and, at present, as an example of one of our databases, ChemSpider is accessed by many tens of thousands of scientists every day. But do these collections constitute “Big Data” or is it the potential which lies within the collections that can contribute to the Big Data movement. This presentation will discuss our activities to contribute both data, and service-based access to our data sets, to support grant-based projects such as the Innovative Medicines Initiative Open PHACTS project (to support drug discovery) and the PharmaSea initiative (to identify novel natural products from the ocean). We will also provide an overview of our activities to perform data mining of public patent collections and examine what can be done with the data. We are presently extracting physicochemical properties and textual forms of NMR spectra and, with the resulting data, are building predictive models (for melting points at present) and assembling a large NMR spectral database containing many hundreds of thousands of spectral-structure pairs. Our experiences to date have demonstrated that we are working at the edge of current algorithmic and computing capabilities for predictive model building, with over a quarter of a million melting points producing a matrix of over 200 billion descriptors. Our work to produce the NMR spectral database will necessitate batch processing of the data to examine consistency between the spectral-structure pairs and other forms of data validation. The intention is to take our experiences in this work applied to a public patents corpus and apply it to the RSC back file of publications to mine data and enable new paths to the discoverability of both data and the associated publications. Emergency Department Throughput: Using DES as an effective tool for decision ...
This document discusses using discrete event simulation (DES) to support decision making in emergency departments. DES allows modeling of dynamic patient flow and testing of "what if" scenarios. The document outlines best practices for setting up successful DES projects including defining objectives, gathering quality data, validating models, and including frontline staff. Case studies demonstrate how DES has been used at hospitals to evaluate options for capacity changes, process improvements, and reducing wait times.
Clinical Biochemistry.ppt
The document provides an overview of clinical biochemistry, including:
1) Testing procedures that will be used for exams, which will be based on lecture materials.
2) The roles and functions of a clinical chemistry laboratory, including providing diagnostic tests, consultation, education, and research support.
3) Sources of variation that can affect laboratory test results, such as pre-analytical factors related to specimen collection, transport, and processing, and analytical and post-analytical errors.
Non academic clinical researcher
This document discusses how to pursue academic research as an orthopaedic surgeon outside of a university setting. It encourages developing a research question that is interesting and unanswered. Initial steps include learning statistics, conducting a literature review, and getting help from mentors. Securing funding may involve grants, philanthropy, or commercial support. Disseminating findings through publications and presentations helps advance evidence-based practice. With passion, focus, and persistence, the document argues that successful clinical research is possible outside a university.
Providing support for JC Bradleys vision of open science using RSC cheminform...
Providing support for JC Bradleys vision of open science using RSC cheminform...US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
Jean-Claude Bradley had an incredible passion for providing open science tools and data to the community. He had boundless energy, no shortage of ideas and ran so many projects in parallel that it was often difficult to keep up. But at RSC we tried. We provided access to our data, our application programming interfaces and lots of our out-of-hours time to help turn his vision into reality. As a result we helped in the delivery of the SpectralGame to help people learn about NMR and we supported the integration of our services into GoogleDocs underpinning the management and curation of physicochemical property data. We tweaked a number of our services based on JC’s input and as a result we have ended up with a suite of capabilities that serve many of our existing efforts to integrate to electronic lab notebooks and support the ongoing shift towards Open Chemistry. JC was very much ahead of his time….and we were glad to have supported his work. This presentation will give a snapshot of some of the work we did to support his vision. Medidata AMUG Meeting / Presentation 2013
The document discusses how Spaulding Clinical leverages Rave Web Services (RWS) to integrate their phase 1 clinical trials seamlessly with sponsors' Rave electronic data capture (EDC) systems. It describes Spaulding's SCi Rave system, which uses a loader file, extract-transform-load processes, and an interface engine to transfer study data from Spaulding to Rave in near real-time or on scheduled transfers. The system architecture is flexible and has successfully transferred thousands of records across multiple studies with no manual data entry needed. The document concludes by envisioning further integration of devices, sensors and other data sources using systems like RWS.
SHE, Quality, and Ethics in Medical Laboratories - PCLP
The document discusses various topics related to medical laboratories including quality control, safety, and ethics. It begins by covering types of quality control including internal quality control methods to check precision and external quality assessment schemes to check accuracy. It then discusses types of hazards in medical laboratories including chemical, physical, biological, and safety hazards. Recommendations are provided for safely handling chemical hazards. Finally, the document discusses the importance of ethics in relation to one's profession, laboratory premises, patients, and community.
Search filters Overview for CareSearch
Everything you wanted to know about search filters and what they mean for CareSearch: what are they, how do we create them and how are they used?
CEDAR work bench for metadata management
With the explosion of interest in both enhanced knowledge management and open science, the past few years have seen considerable discussion about making scientific data “FAIR” — findable, accessible, interoperable, and reusable. The problem is that most scientific datasets are not FAIR. When left to their own devices, scientists do an absolutely terrible job creating the metadata that describe the experimental datasets that make their way in online repositories. The lack of standardization makes it extremely difficult for other investigators to locate relevant datasets, to re-analyse them, and to integrate those datasets with other data. The Center for Expanded Data Annotation and Retrieval (CEDAR) has the goal of enhancing the authoring of experimental metadata to make online datasets more useful to the scientific community. The CEDAR work bench for metadata management will be presented in this webinar. CEDAR illustrates the importance of semantic technology to driving open science. It also demonstrates a means for simplifying access to scientific data sets and enhancing the reuse of the data to drive new discoveries.
ANZICS S&Q 2014 - RRT: Peter Hicks on Do we need a RRT registry?
Peter Hicks on Do we need a RRT registry? Presented at the ANZICS S&Q Conference 2014 on Rapid Response Teams.
LABORATORY INFORMATION SYSTEM
This document discusses laboratory information systems (LIS). It begins by defining an LIS as a healthcare software solution that processes, stores, and manages patient data related to laboratory processes and testing. It then describes how an LIS works, recording, managing, updating, and storing patient testing data for clinical and anatomic pathology laboratories. The document also outlines the core components of an LIS, including sample tracking, protocol execution, and storage organization. It discusses why LIS are important for modern laboratories, noting they are crucial for organization, accuracy, and collaboration.
Clinical data management electronic data capture
This document discusses guidelines for managing clinical trial data, including sources of clinical data, stakeholders in clinical trials and their roles, methods of data capture such as optical character recognition and electronic data capture, challenges with data collection like missing or incorrect data, and features of electronic data capture systems such as centralized administration and real-time data validation.
Study Design - testing and approval - how to do this efficiently and to keep...
This document provides guidance on using ClinSpark for clinical trial design and data collection. It discusses setting up form libraries, defining objectives for different roles, and tips for creating studies, events, items, and code lists. Challenges addressed include transferring subjects between studies and designing adverse event forms. Lessons learned include needing static dates on forms and the usefulness of repeating forms. The document aims to help new users of ClinSpark understand how to structure studies and optimize the software.
Our dire need to mandate data standards and expectations for scientific publi...
Our dire need to mandate data standards and expectations for scientific publi...US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
The document discusses the need for mandating data standards and open sharing in scientific publishing. It notes the loss of data reproducibility due to a lack of standardized data formats. The author advocates that publishers should require authors to register chemical compounds, submit spectral data in standard digital formats rather than images, and make data openly available with metadata and provenance. Adopting standards like CVSP could help validate structures and spectra before publication. While mandates may not be preferred, open data standards are important for scientific progress and reproducibility.Clinical research design
This document discusses key considerations for clinical research design such as having a clear research question, selecting an appropriate design that best answers the question, considering feasibility factors, ensuring the work is interesting, relevant, novel, and ethical. It provides examples of common research designs like randomized controlled trials, surveys, qualitative research, and systematic reviews. It highlights common mistakes like having an overly ambitious project or deciding on methods before the research question. The conclusion emphasizes having a clear research question to guide design, methods, and getting necessary support and approvals.
Clinical Trials in Russia from a central lab perspective
Russia has a huge potential for clinical trials to achieve fast patient recruitment and a low drop-out rate. However, a rapidly changing regulatory environment and continuous issues with supply chain and logistics are holding up clinical study sponsors to utilize all benefits of the region.
New clinical trial regulations and restrictions are introduced almost every quarter and together with lengthy custom clearance process and poor road infrastructure, this adds to unpredicted and significant delays.
A local expert partner who has a deep knowledge of actual clinical trials regulations and legislation. Understanding the realities and requirements of the import/export process is a critical factor in the success of trials conducted in Russia.
The perfect provider would also support you in other European countries and integrate your clinical data from Russia into single harmonized database with results collected from the whole trial.
elns-the-opinions-of-physical-chemists_tcm18-244630.pptx
Electronic lab notebooks (ELNs) could help physical chemists better organize their research data and notes. Interviews found most physical chemists struggle with poor note-taking and difficulty finding past work. While some use basic data management tools, dedicated ELNs remain uncommon. Researchers saw benefits but also challenges. To be useful, an ELN would need to be affordable, have flexible access, effective interfaces for recording narratives and data, and features like drawing and linking files. Barriers to adoption include costs, infrastructure needs, and changing existing practices. Overall, researchers were open to ELNs but current options have not fully met their needs and requirements.
CloudCamp Chicago - Healthcare IT
CloudCamp Chicago - Healthcare IT
September 3rd, 2014
How are Cloud, the Internet of Things, and mobile devices disrupting healthcare IT? Are these tools or security threats? What do doctors, administrators, researchers, nurses, and patients think of technology? On Sept 3rd we discussed the future of healthcare and technology. Event info: cloudcampchicago.eventbrite.com
Lightning Talks Included in these slides:
"Security and Sanity in the HIPAA-Compliant Workplace" - Alex Connor, Lead Architect at Crimson Care Management at Advisory Board Co
"QS and Biohacking movements” - Mark Moschel, Chief Technology Officer at Factor 75
"We are doctors who take care of patients. What can technology do for us?" - Dr. Griffin Myers, Co-founder and Chief Medical Officer at Oak Street Health
"Removing Silos in Healthcare" - Carol Zindler, Vice President, Client Experience at CareMerge
Sign up and join us next time: cloudcampchicago.eventbrite.com
Enabling Healthcare Interoperability, Will Tesch, HealthLX
This document provides an overview of HealthLX, a company that aims to enable healthcare interoperability. It discusses the current challenges around data integration and exchange in healthcare. HealthLX offers a managed healthcare integration platform (HIP) that can connect different data sources, including claims, EMRs, devices, and applications. It also provides data governance and integration services to help automate processes and enable use cases like population health analytics and case management. The platform aims to help payors and providers achieve better care coordination and support the Triple Aim of healthcare.
Using database read replicas for ad hoc reporting, data visualisation and gen...
The document discusses ClinSpark read replicas, which are full read-only copies of production clinical trial data. The read replicas allow customers to explore their own data using the tools of their choice, such as business intelligence tooling, ad hoc queries, or favorite reporting tools. The read replicas also enable customers to integrate the clinical data with existing data marts or warehouses.
More Related Content
Similar to Choosing an eSource System, Daniel Selness, Spaulding Clinical Research
The role of the laboratory
The document discusses the roles of public health laboratories and forensic laboratories. It describes how public health laboratories support disease investigation and outbreak response. They work with the Laboratory Response Network (LRN) to identify pathogens. Forensic laboratories assist with criminal investigations by analyzing evidence. Both types of laboratories follow strict chain of custody procedures to ensure sample integrity which is important for legal purposes. Public health laboratories are regulated at the state level while forensic laboratories work with law enforcement and medical examiners.
Activities at the Royal Society of Chemistry to gather, extract and analyze b...
Activities at the Royal Society of Chemistry to gather, extract and analyze b...US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
The phrase “Big Data” is generally used to describe a large volume of structured and/or unstructured data that cannot be processed using traditional database and software techniques. In the domain of chemistry the Royal Society of Chemistry certainly hosts large structured databases of chemistry data, for example ChemSpider, as well as unstructured content, in the form of our collection of scientific articles. Our research literature provides value to their readership and, at present, as an example of one of our databases, ChemSpider is accessed by many tens of thousands of scientists every day. But do these collections constitute “Big Data” or is it the potential which lies within the collections that can contribute to the Big Data movement. This presentation will discuss our activities to contribute both data, and service-based access to our data sets, to support grant-based projects such as the Innovative Medicines Initiative Open PHACTS project (to support drug discovery) and the PharmaSea initiative (to identify novel natural products from the ocean). We will also provide an overview of our activities to perform data mining of public patent collections and examine what can be done with the data. We are presently extracting physicochemical properties and textual forms of NMR spectra and, with the resulting data, are building predictive models (for melting points at present) and assembling a large NMR spectral database containing many hundreds of thousands of spectral-structure pairs. Our experiences to date have demonstrated that we are working at the edge of current algorithmic and computing capabilities for predictive model building, with over a quarter of a million melting points producing a matrix of over 200 billion descriptors. Our work to produce the NMR spectral database will necessitate batch processing of the data to examine consistency between the spectral-structure pairs and other forms of data validation. The intention is to take our experiences in this work applied to a public patents corpus and apply it to the RSC back file of publications to mine data and enable new paths to the discoverability of both data and the associated publications. Emergency Department Throughput: Using DES as an effective tool for decision ...
This document discusses using discrete event simulation (DES) to support decision making in emergency departments. DES allows modeling of dynamic patient flow and testing of "what if" scenarios. The document outlines best practices for setting up successful DES projects including defining objectives, gathering quality data, validating models, and including frontline staff. Case studies demonstrate how DES has been used at hospitals to evaluate options for capacity changes, process improvements, and reducing wait times.
Clinical Biochemistry.ppt
The document provides an overview of clinical biochemistry, including:
1) Testing procedures that will be used for exams, which will be based on lecture materials.
2) The roles and functions of a clinical chemistry laboratory, including providing diagnostic tests, consultation, education, and research support.
3) Sources of variation that can affect laboratory test results, such as pre-analytical factors related to specimen collection, transport, and processing, and analytical and post-analytical errors.
Non academic clinical researcher
This document discusses how to pursue academic research as an orthopaedic surgeon outside of a university setting. It encourages developing a research question that is interesting and unanswered. Initial steps include learning statistics, conducting a literature review, and getting help from mentors. Securing funding may involve grants, philanthropy, or commercial support. Disseminating findings through publications and presentations helps advance evidence-based practice. With passion, focus, and persistence, the document argues that successful clinical research is possible outside a university.
Providing support for JC Bradleys vision of open science using RSC cheminform...
Providing support for JC Bradleys vision of open science using RSC cheminform...US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
Jean-Claude Bradley had an incredible passion for providing open science tools and data to the community. He had boundless energy, no shortage of ideas and ran so many projects in parallel that it was often difficult to keep up. But at RSC we tried. We provided access to our data, our application programming interfaces and lots of our out-of-hours time to help turn his vision into reality. As a result we helped in the delivery of the SpectralGame to help people learn about NMR and we supported the integration of our services into GoogleDocs underpinning the management and curation of physicochemical property data. We tweaked a number of our services based on JC’s input and as a result we have ended up with a suite of capabilities that serve many of our existing efforts to integrate to electronic lab notebooks and support the ongoing shift towards Open Chemistry. JC was very much ahead of his time….and we were glad to have supported his work. This presentation will give a snapshot of some of the work we did to support his vision. Medidata AMUG Meeting / Presentation 2013
The document discusses how Spaulding Clinical leverages Rave Web Services (RWS) to integrate their phase 1 clinical trials seamlessly with sponsors' Rave electronic data capture (EDC) systems. It describes Spaulding's SCi Rave system, which uses a loader file, extract-transform-load processes, and an interface engine to transfer study data from Spaulding to Rave in near real-time or on scheduled transfers. The system architecture is flexible and has successfully transferred thousands of records across multiple studies with no manual data entry needed. The document concludes by envisioning further integration of devices, sensors and other data sources using systems like RWS.
SHE, Quality, and Ethics in Medical Laboratories - PCLP
The document discusses various topics related to medical laboratories including quality control, safety, and ethics. It begins by covering types of quality control including internal quality control methods to check precision and external quality assessment schemes to check accuracy. It then discusses types of hazards in medical laboratories including chemical, physical, biological, and safety hazards. Recommendations are provided for safely handling chemical hazards. Finally, the document discusses the importance of ethics in relation to one's profession, laboratory premises, patients, and community.
Search filters Overview for CareSearch
Everything you wanted to know about search filters and what they mean for CareSearch: what are they, how do we create them and how are they used?
CEDAR work bench for metadata management
With the explosion of interest in both enhanced knowledge management and open science, the past few years have seen considerable discussion about making scientific data “FAIR” — findable, accessible, interoperable, and reusable. The problem is that most scientific datasets are not FAIR. When left to their own devices, scientists do an absolutely terrible job creating the metadata that describe the experimental datasets that make their way in online repositories. The lack of standardization makes it extremely difficult for other investigators to locate relevant datasets, to re-analyse them, and to integrate those datasets with other data. The Center for Expanded Data Annotation and Retrieval (CEDAR) has the goal of enhancing the authoring of experimental metadata to make online datasets more useful to the scientific community. The CEDAR work bench for metadata management will be presented in this webinar. CEDAR illustrates the importance of semantic technology to driving open science. It also demonstrates a means for simplifying access to scientific data sets and enhancing the reuse of the data to drive new discoveries.
ANZICS S&Q 2014 - RRT: Peter Hicks on Do we need a RRT registry?
Peter Hicks on Do we need a RRT registry? Presented at the ANZICS S&Q Conference 2014 on Rapid Response Teams.
LABORATORY INFORMATION SYSTEM
This document discusses laboratory information systems (LIS). It begins by defining an LIS as a healthcare software solution that processes, stores, and manages patient data related to laboratory processes and testing. It then describes how an LIS works, recording, managing, updating, and storing patient testing data for clinical and anatomic pathology laboratories. The document also outlines the core components of an LIS, including sample tracking, protocol execution, and storage organization. It discusses why LIS are important for modern laboratories, noting they are crucial for organization, accuracy, and collaboration.
Clinical data management electronic data capture
This document discusses guidelines for managing clinical trial data, including sources of clinical data, stakeholders in clinical trials and their roles, methods of data capture such as optical character recognition and electronic data capture, challenges with data collection like missing or incorrect data, and features of electronic data capture systems such as centralized administration and real-time data validation.
Study Design - testing and approval - how to do this efficiently and to keep...
This document provides guidance on using ClinSpark for clinical trial design and data collection. It discusses setting up form libraries, defining objectives for different roles, and tips for creating studies, events, items, and code lists. Challenges addressed include transferring subjects between studies and designing adverse event forms. Lessons learned include needing static dates on forms and the usefulness of repeating forms. The document aims to help new users of ClinSpark understand how to structure studies and optimize the software.
Our dire need to mandate data standards and expectations for scientific publi...
Our dire need to mandate data standards and expectations for scientific publi...US Environmental Protection Agency (EPA), Center for Computational Toxicology and Exposure
The document discusses the need for mandating data standards and open sharing in scientific publishing. It notes the loss of data reproducibility due to a lack of standardized data formats. The author advocates that publishers should require authors to register chemical compounds, submit spectral data in standard digital formats rather than images, and make data openly available with metadata and provenance. Adopting standards like CVSP could help validate structures and spectra before publication. While mandates may not be preferred, open data standards are important for scientific progress and reproducibility.Clinical research design
This document discusses key considerations for clinical research design such as having a clear research question, selecting an appropriate design that best answers the question, considering feasibility factors, ensuring the work is interesting, relevant, novel, and ethical. It provides examples of common research designs like randomized controlled trials, surveys, qualitative research, and systematic reviews. It highlights common mistakes like having an overly ambitious project or deciding on methods before the research question. The conclusion emphasizes having a clear research question to guide design, methods, and getting necessary support and approvals.
Clinical Trials in Russia from a central lab perspective
Russia has a huge potential for clinical trials to achieve fast patient recruitment and a low drop-out rate. However, a rapidly changing regulatory environment and continuous issues with supply chain and logistics are holding up clinical study sponsors to utilize all benefits of the region.
New clinical trial regulations and restrictions are introduced almost every quarter and together with lengthy custom clearance process and poor road infrastructure, this adds to unpredicted and significant delays.
A local expert partner who has a deep knowledge of actual clinical trials regulations and legislation. Understanding the realities and requirements of the import/export process is a critical factor in the success of trials conducted in Russia.
The perfect provider would also support you in other European countries and integrate your clinical data from Russia into single harmonized database with results collected from the whole trial.
elns-the-opinions-of-physical-chemists_tcm18-244630.pptx
Electronic lab notebooks (ELNs) could help physical chemists better organize their research data and notes. Interviews found most physical chemists struggle with poor note-taking and difficulty finding past work. While some use basic data management tools, dedicated ELNs remain uncommon. Researchers saw benefits but also challenges. To be useful, an ELN would need to be affordable, have flexible access, effective interfaces for recording narratives and data, and features like drawing and linking files. Barriers to adoption include costs, infrastructure needs, and changing existing practices. Overall, researchers were open to ELNs but current options have not fully met their needs and requirements.
CloudCamp Chicago - Healthcare IT
CloudCamp Chicago - Healthcare IT
September 3rd, 2014
How are Cloud, the Internet of Things, and mobile devices disrupting healthcare IT? Are these tools or security threats? What do doctors, administrators, researchers, nurses, and patients think of technology? On Sept 3rd we discussed the future of healthcare and technology. Event info: cloudcampchicago.eventbrite.com
Lightning Talks Included in these slides:
"Security and Sanity in the HIPAA-Compliant Workplace" - Alex Connor, Lead Architect at Crimson Care Management at Advisory Board Co
"QS and Biohacking movements” - Mark Moschel, Chief Technology Officer at Factor 75
"We are doctors who take care of patients. What can technology do for us?" - Dr. Griffin Myers, Co-founder and Chief Medical Officer at Oak Street Health
"Removing Silos in Healthcare" - Carol Zindler, Vice President, Client Experience at CareMerge
Sign up and join us next time: cloudcampchicago.eventbrite.com
Similar to Choosing an eSource System, Daniel Selness, Spaulding Clinical Research (20)
Activities at the Royal Society of Chemistry to gather, extract and analyze b...
Activities at the Royal Society of Chemistry to gather, extract and analyze b...
Emergency Department Throughput: Using DES as an effective tool for decision ...
Emergency Department Throughput: Using DES as an effective tool for decision ...
Providing support for JC Bradleys vision of open science using RSC cheminform...
Providing support for JC Bradleys vision of open science using RSC cheminform...
SHE, Quality, and Ethics in Medical Laboratories - PCLP
SHE, Quality, and Ethics in Medical Laboratories - PCLP
ANZICS S&Q 2014 - RRT: Peter Hicks on Do we need a RRT registry?
ANZICS S&Q 2014 - RRT: Peter Hicks on Do we need a RRT registry?
Study Design - testing and approval - how to do this efficiently and to keep...
Study Design - testing and approval - how to do this efficiently and to keep...
Our dire need to mandate data standards and expectations for scientific publi...
Our dire need to mandate data standards and expectations for scientific publi...
Clinical Trials in Russia from a central lab perspective
Clinical Trials in Russia from a central lab perspective
elns-the-opinions-of-physical-chemists_tcm18-244630.pptx
elns-the-opinions-of-physical-chemists_tcm18-244630.pptx
More from Steffan Stringer
Enabling Healthcare Interoperability, Will Tesch, HealthLX
This document provides an overview of HealthLX, a company that aims to enable healthcare interoperability. It discusses the current challenges around data integration and exchange in healthcare. HealthLX offers a managed healthcare integration platform (HIP) that can connect different data sources, including claims, EMRs, devices, and applications. It also provides data governance and integration services to help automate processes and enable use cases like population health analytics and case management. The platform aims to help payors and providers achieve better care coordination and support the Triple Aim of healthcare.
Using database read replicas for ad hoc reporting, data visualisation and gen...
The document discusses ClinSpark read replicas, which are full read-only copies of production clinical trial data. The read replicas allow customers to explore their own data using the tools of their choice, such as business intelligence tooling, ad hoc queries, or favorite reporting tools. The read replicas also enable customers to integrate the clinical data with existing data marts or warehouses.
Accelerating the production of safety summary and clinical safety reports - a...
This document discusses automating the production of safety summaries and clinical study reports using LaTeX, R, and source control. It proposes a workflow where clinical data is transformed into CDISC SDTM/ADaM formats using R, and reports are generated as reproducible documents combining LaTeX documentation with R code and output. This approach aims to reduce errors, accelerate delivery times, and allow easier collaboration between physicians, data managers, programmers and writers. The key benefits are presented as producing clinical reports as reproducible code and establishing a fully integrated process for analysis and reporting.
Strategies for success - volunteer recruitment & prevention of over-volunteer...
This document discusses strategies for volunteer recruitment and preventing over-volunteering in clinical trials. It recommends conducting regular feasibility studies to understand capabilities for trials. Database building through generic advertising can help recruit volunteers. Analytics and tracking can influence changes needed in recruitment strategies. System integration of recruitment websites and internal systems can improve efficiency. Case studies show integration reducing call times and volumes. Preventing over-volunteering requires checking volunteers' participation history and restricting repeat offenders.
Why Data Management Needs To Be Involved In Study Design, Katrien Vermeiren, ...
This document discusses the importance of involving data management in study design. It summarizes SGS Life Sciences' experience introducing an electronic data capture (eSource) system and lessons learned. Data management found issues with missing data, non-compliant data structures, and unclear relationships between data points when receiving case report form data extracted from eSource. SGS now works closely with a dedicated study design team and data management to optimize libraries for standard data conversion and ensure requirements are met. The next steps are introducing clinical data acquisition standards and a new eSource system to make SGS future proof.
ECG Interoperability and Industry Trends, Dr Justin Mortara, Mortara Instrument
This document discusses ECG interoperability and industry trends. It describes Mortara Instrument as a leading provider of diagnostic cardiology and monitoring devices, as well as ECG algorithms. The document outlines the path from proprietary to fully interoperable ECG systems, including a case study of an HL7 standard. It also looks ahead at trends like increased connectivity, data collection, and focus on security and standards. The future of Phase 1 eSource integration is presented as leveraging open architecture and standards to connect diverse ECG devices.
SaaS System Validation, practical tips on getting validated for go-live and t...
Validation is required for computerized systems used in regulated activities according to regulations like EMA Annex 11 and FDA 21 CFR Part 11. While traditional validation is project-based, agile development uses iterative sprints requiring a different validation approach. When using SaaS, the regulated company performs validation activities while leveraging documentation from the SaaS provider. Both parties should work together throughout product setup and testing to facilitate validation.
Hardware Choices, Form Factors, and Medical Devices. What drove our choices? ...
This document summarizes the location and facilities of AXIS Clinicals, a clinical research organization located in Dilworth, Minnesota near Fargo, North Dakota. The facility has 180 beds across 3 study units and can dose up to 1,000 subjects per month. It has 10 LC-MS/MS machines, 15,000 samples/month analysis capacity, and 120,000 square feet. AXIS Clinicals uses various hardware like Microsoft Surfaces, desktops, and medical devices from different vendors for electronic data capture in areas like screening, studies, and specified devices. Foundry Health's flexibility allowed them to interface existing equipment for eSource data collection.
Trends in Early Phase Clinical Research and how you can be ready for them, Dr...
- Early phase clinical trials are facing challenges including increased complexity, data sources, and planning variability. Transcription of data is being moved away from as integrated eSource/CRF solutions emerge.
- More clinical trial sites are being used for early phase studies as patients are increasingly included earlier. This is managed through simple and patient-centric eSource/CRF solutions.
- The technology revolution in clinical development has only just begun, with opportunities to increase data quality and safety, shorten timelines, and reduce costs through disruptive eSource/CRF solutions that integrate sponsors, sites, patients and other stakeholders.
More from Steffan Stringer (9)
Enabling Healthcare Interoperability, Will Tesch, HealthLX
Enabling Healthcare Interoperability, Will Tesch, HealthLX
Using database read replicas for ad hoc reporting, data visualisation and gen...
Using database read replicas for ad hoc reporting, data visualisation and gen...
Accelerating the production of safety summary and clinical safety reports - a...
Accelerating the production of safety summary and clinical safety reports - a...
Strategies for success - volunteer recruitment & prevention of over-volunteer...
Strategies for success - volunteer recruitment & prevention of over-volunteer...
Why Data Management Needs To Be Involved In Study Design, Katrien Vermeiren, ...
Why Data Management Needs To Be Involved In Study Design, Katrien Vermeiren, ...
ECG Interoperability and Industry Trends, Dr Justin Mortara, Mortara Instrument
ECG Interoperability and Industry Trends, Dr Justin Mortara, Mortara Instrument
SaaS System Validation, practical tips on getting validated for go-live and t...
SaaS System Validation, practical tips on getting validated for go-live and t...
Hardware Choices, Form Factors, and Medical Devices. What drove our choices? ...
Hardware Choices, Form Factors, and Medical Devices. What drove our choices? ...
Trends in Early Phase Clinical Research and how you can be ready for them, Dr...
Trends in Early Phase Clinical Research and how you can be ready for them, Dr...
Recently uploaded
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
A Classical Text Review on Basavarajeeyam
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Light House Retreats: Plant Medicine Retreat Europe
Our aim is to organise conscious gatherings and retreats for open and inquisitive minds and souls, with and without the assistance of sacred plants.
The Electrocardiogram - Physiologic Principles
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
ABDOMINAL TRAUMA in pediatrics part one.
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Identification and nursing management of congenital malformations .pptx
Identification and nursing management of congenital malformations .pptxMGM SCHOOL/COLLEGE OF NURSING
Identification and nursing management of congenital malformations Adhd Medication Shortage Uk - trinexpharmacy.com
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
share - Lions, tigers, AI and health misinformation, oh my!.pptx
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Novas diretrizes da OMS para os cuidados perinatais de mais qualidade
Novas diretrizes da OMS para os cuidados perinatais de mais qualidadeProf. Marcus Renato de Carvalho
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Does Over-Masturbation Contribute to Chronic Prostatitis.pptx
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Recently uploaded (20)
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis - Definition , Evaluation and Management .pdf
Light House Retreats: Plant Medicine Retreat Europe
Light House Retreats: Plant Medicine Retreat Europe
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Muscles of Mastication by Dr. Rabia Inam Gandapore.pptx
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotes
Identification and nursing management of congenital malformations .pptx
Identification and nursing management of congenital malformations .pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
share - Lions, tigers, AI and health misinformation, oh my!.pptx
Thyroid Gland- Gross Anatomy by Dr. Rabia Inam Gandapore.pptx
Thyroid Gland- Gross Anatomy by Dr. Rabia Inam Gandapore.pptx
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...
Novas diretrizes da OMS para os cuidados perinatais de mais qualidade
Novas diretrizes da OMS para os cuidados perinatais de mais qualidade
Tests for analysis of different pharmaceutical.pptx
Tests for analysis of different pharmaceutical.pptx
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Dehradun #ℂall #gIRLS Oyo Hotel 8107221448 #ℂall #gIRL in Dehradun
Does Over-Masturbation Contribute to Chronic Prostatitis.pptx
Does Over-Masturbation Contribute to Chronic Prostatitis.pptx
Choosing an eSource System, Daniel Selness, Spaulding Clinical Research
- 2. What will I be covering? • About Dan Selness • About Spaulding Clinical Research • Who are we talking about • What are we talking about • Why eSource • What you need to look for • What you need to look out for • Where is it going • What does success look and feel like? • Open Discussion/Questions?
- 3. Who am I • Clinical Researcher • 25 years • 50/50 • Phase 1 • Phlebotomist to CSO • Systems Owner2 • Lived through 3 eSource systems
- 4. Who Is Spaulding Clinical • ClinSpark User • Clinical Pharmacology Research Unit • 200 Beds • Paperless • Integrations • Onsite ECG and Clinical Lab • FIM/SAD/MAD and TQT/CEQT expertise • All Phase Cardiac Core Lab • Full Service Biometrics
- 5. Who are/were we really talking about? • Omnicom “TrialOne” • Instem “AlphaDas” • Phase 1 Management Systems “PIMs“ • Oracle “LabPass” • Clinical Ink/Medrio
- 6. What are we really talking about? • Subject database • eSource Data Collection • Barcode enabled sample management • Protocol Management Tool • Electronic signatures/audit trail capabilities (Part 11) • Device integrations • Lab/HL-7 integrations • Remote data review abilities • Faster, more compliant data export abilities • End to end operational abilities
- 7. Why eSource? • Why not, it is the hot thing everyone is talking about? • Increased data quality • Increase protocol compliance • Real-time data access • Point of collection data checks • Increased Sponsor and Monitor satisfaction • Decreased study start up • Removal of steps in the data process • Faster database lock and export datasets
- 8. What do you need to look for • Fully operational system (reference sites) • SDLC and validation support • Part 11 Compliance • Implementation assistance • Scalability • Hosted vs. cloud based • System enhancement schedule • CDISC/ODM compliant • Internal champions** • Approach with the end in mind
- 9. What do you need to look out for • No reference sites • Has to be this way • Internal boat anchors/legacy mindsets • Overcomplicating things
- 10. Where is it going? • eSource usage will grow exponentially over the next 10 years • Studies will continue to get more complex • Device integrations get easier • eSource/EMR integration is the future • Benefits to big data • Start up and Close Out timelines will continue to shrink • Paving way for easier RBM
- 11. What does success look like? • Happy staff • Highly efficient staff • Data transparency • Shrinking timelines • Happy Sponsors • Happy Monitors • Availability of performance indicators