INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH"

Transcription

1 INSERT COMPANY LOGO HERE BEST PRACTICES RESEARCH

2 Background and Company Performance Industry Challenges esource: Electronic Clinical Trial Solution Clinical trial sponsors and clinical research organizations are facing intense pressures to change the way clinical research is conducted in order to decrease costs and speed up the Research and Development (R&D) process. R&D budgets for human trials (Phases 1-3) have increased from $13 billion to $40 billion ( ) with clinical trial outsourcing costing close to one-third of the budget. Bringing an approved new drug from initial private investment to a patient takes over 13 years and $1.3 billion, or an average of $146 million per year. Industry data shows that clinical trial costs are growing across all development phases. Across multiple therapeutic areas, per-patient clinical trial costs increased an average of 70% from 2008 to The largest increases occurred in Phase IIIa and Phase IIIb. Phase I trials are also suffering from cost inflation, with per-patient costs increasing by an average of 46% over the same time period. Clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the United States (US). In fact, recent estimates indicate that within the next three years, up to 65% of studies under Federal Drug Administration (FDA) regulation will be conducted outside of the US. A review of clinicaltrials.gov and of 300 published reports in major medical journals revealed that one-third (157 of 509) of Phase III trials were being conducted entirely outside of the US, with over half the study sites (13,521 of 24,206) located overseas, including many in Eastern Europe and Asia. The ultimate goal is to bring new treatments to market sooner and address unmet patient needs more quickly. An electronic data management strategy can help sponsors and managing clinical research organizations (CROs) achieve this goal. Comprehensive solutions are needed to implement this strategy, and technological advances such as cloud computing, analytics, and data repository solutions help facilitate this implementation easily and cost-effectively. FDA Guidance on Electronic Data in Clinical Investigations The FDA s first guidance for the use of electronic data capturing (EDC) in clinical trials was issued in 1997 with 21 CFR Part 11. Ever since then, to keep up with the ever-evolving electronic data world, the FDA has provided additional guidance to address topics ranging from responsibilities for monitoring, electronic submissions, electronic signatures, and system validation. Even with these amendments and clarifications, widespread adoption of

3 EDC has taken more than a decade, and complete electronic data submission remains an elusive goal with new draft guidance by FDA issued earlier this year. Despite the challenges, over the last several years the pharmaceutical industry has largely embraced web-based EDC systems as the preferred means for research sites to input, share, and store trial data electronically. However, the widespread adoption of EDC systems has failed to significantly reduce the cost of conducting clinical research, as EDC does nothing to address the most critical step in the data collection process: the initial point of capture with the patient. Because the initial source documentation continues to be done via paper -- whether or not an EDC system is used later in the process -- data collection remains error-prone, time-consuming, and insecure and negatively impacts other related processes, particularly site monitoring and data cleaning activities. The evidence suggests that simply having an EDC system in place is not enough to achieve optimal speed, efficiency and safety/quality. Sponsors need to focus on areas that maximize their EDC investment to decrease timelines and costs associated with conducting clinical trials, creating more return on investment. Recent Regulatory Guidance on Clinical Investigations (2013) In September 2013, after several years of effort, the FDA released final guidance on electronic source (esource) data in clinical investigations; the European Medicines Agency (EMA) previously released its Reflection paper on esource in These recommendations ensure the reliability, quality, integrity, and traceability of data from the electronic source to the electronic regulatory submission that will need to be considered when sponsors select their data collection systems. Notably, the FDA acknowledges that the industry has been slow to adopt EDC in the past and states that the express purpose of this new guidance is to encourage and promote adoption of electronic source technologies to capture data directly during a subject visit and to remotely review data in real-time. The agency even outlines the expected industry benefits of adopting esource: eliminating unnecessary duplication of data and associated transcription errors. The concept of Source is well-established in the regulatory landscape and has its roots in ICH Good Clinical Practices where it refers to the variety of original documents and data used in a clinical trial. These documents include items like hospital records, clinical and office charts, lab notes, diaries, pharmacy records, X-rays, and even film. esource can also refer to data collected in the trial, such as clinical findings, observations, and evaluations conducted on the patient. With a purpose-built esource platform system design (e.g., comprehensive audit trails, risk based remote monitoring, back-up & disaster recovery), and good clinical report form (CRF) design (e.g., proper data element identifiers, robust use of edit checks, and

4 electronic prompts for missing or inconsistent data), the goals of reliability, quality, integrity, and traceability mentioned in the 2013 FDA esource Requirements can be achieved. Critically, this requires a focus on the needs of site users beyond what has traditionally been considered by many EDC solutions which tend to only address the needs of data managers for standardized/consistent data. The advantages of esource extend to a number of electronically collected data. In one case study, the newer platform applications of electronic computerized tomography (CT) monitoring have been estimated to eliminate over 70% of possible errors from manual inputting and save nearly 40% on monitoring travel expenses for source verification site visits. These savings will only increase in the coming years due to the increased number of clinical trials conducted in emerging countries. The FDA s esource guidance also clearly complements the agency s final risk-based monitoring guidance (released August 2013) which discusses a move away from Source Data Verification (SDV) where [you re] simply assuring the accuracy of information through audits, on-site visits and other costly measures to a more efficient electronic source data verifications. (Jonathan Helfgott, Office of Compliance [FDA]). Real-time data collection allows esource platforms to conduct risk-based monitoring, which is an approach that is currently being encouraged by the FDA. Additionally, realtime data collection empowers centralized trial monitoring, which can provide insights into clinical trial data at an early stage, when sponsors and researchers can act and have a positive impact on study outcomes. Entrepreneurial Innovation and Customer Impact of Clinical Ink eclinical Solution Clinical Ink, an eclinical solutions provider, has developed the industry s first purpose-built esource solution to capture data electronically at the point of care. SureSource, a mobile data collection platform specialized forclinical trials, dramatically reduces development costs and timelines. The rapid growth of multinational CROs and global trials has created a serious demand for data management solutions and platforms that allow for cloud-based collaboration. SureSource is able to meet those demands. Clinical Ink was founded in 2007 and spent several years developing the SureSource platform. The SureSource platform was first used commercially in Since that time, the SureSource platform has been used in more than 50 global clinical trials by 3,000+ users to capture data for nearly 15,000 subjects. SureSource is operated on an electronic tablet, which can be Internet-connected or accessed offline. Clinical Ink can have a study build of custom ecrfs, protocols, and study-specific integrations needed for the clinical trial, all pre-loaded onto the tablet within 8 to 12 weeks. SureSource introduces

5 automation to the clinical trial process by providing a platform that intuitively breaks the procedure down into five primary steps: start, capture, manage, connect, and submit. Start The SureSource study build process is very similar to a standard EDC study build. However, the outputs are paper-like electronic documents that reflect the clinical workflow of research sites. In addition to the required CRF fields in an EDC system, Clinical Ink also builds in data fields and validations related to the ICH GCP guidelines, study-specific compliance metrics, and patient safety that are typically documented in paper. Despite capturing more than twice as much data as in a typical CRF, the Clinical Ink study build process takes no longer than a typical EDC study build. Capture Unlike EDC systems, the SureSource Tablet captures trial data in electronic format duringthe patient visit, and can support a combination of electronic and paper formats. Due to the critical timepoint for data capture during the subject visit the SureSource application is designed to reflect the typical workflow/practices of sites. The tablet gives the clinical investigator the freedom to write the patient s data and any notes directly into the ecrf, eliminating paper and minimizing any source of error and the resulting need for the verification of data. Real-time data validations ensure data is correct as it s captured; and multiple redundant auto-save mechanisms ensure data is never lost; and robust audit trails and privacy permissions ensure data integrity. Manage The SureSource Portal application provides real-time, remote access to esource documents and source data for sponsors, sites, CROs, monitors, and other authorized third parties to dramatically speed overall monitoring and data cleaning processes. The data can be viewed in real-time through dynamic dashboards that allow users to identify open/closed queries, manage adverse events, and track subject completion status. By nearly eliminating SDV, reducing data queries, and minimizing the frequency of monitoring visits, SureSource can greatly impact clinical trial costs and submission times. Connect SureSource can be integrated with many common supporting technologies to further streamline clinical development. Specifically, IVRS system integration permits pushbutton randomization, drug kit assignment, and supply accountability at the site/subject level from directly within SureSource eliminating another error-prone step of inputting subject data into yet another system. Additional integrations with laboratory systems capture physician assessments electronically and eliminate paper copies of laboratory results at the site.

6 Submit SureSource utilizes a number of export utilities to format data consistent with SDTM submission standards (included derived fields) in a submission-ready format, as well as automatically creating submission-ready subject CRFs with all the appropriate visit and domain-level bookmarking. Typically, these are activities that take place outside the EDC system and incur extra time and cost, but are a natural output of the SureSource platform. The critical difference with SureSource is that the SDTM data transformation occurs in real-time as study data is collected. Conclusion Pharmaceutical companies and CROs now have a significant opportunity to speed up clinical trials by building on a foundation of electronic clinical trial management systems. As long as sponsors and CROs work with eclinical solutions providers (like Clinical Ink) that can demonstrate their continuing adherence to these evolving guidelines, their studies will not only remain in compliance, but will benefit from the significant time and cost savings today s eclinical systems have to offer, giving them better returns on their investment. For an esource platform, SureSource is ideal for every phase of clinical development. Its solution uses the latest technology to make clinical research easier for sites, sponsors, subjects, and regulators. SureSource offers the freedom to work without regard to connectivity, while allowing fast and secure electronic transmission of source documents and data, making it ideal for clinical research in remote locations. Clinical research sites located in 18 countries around the world have used Clinical Ink s SureSource platform. Regulatory acceptance has been positive with the company having been invited to present to the FDA several times, EMA GCP Inspectors Working Group, and successfully passed an MHRA site audit of the platform. Clinical Ink s client and user satisfaction has been extremely positive, with nearly 80% of users saying SureSource positively affected their clinical trial process and would use it again. With its strong overall performance, Clinical Ink has earned Frost & Sullivan s 2014 North American eclinical Solutions Entrepreneurial Company of the Year Award.

7 Significance of Entrepreneurial Leadership Ultimately, growth in any organization depends upon customers purchasing from your company, and then making the decision to return time and again. In a sense, then, everything is truly about the customer and making those customers happy is the cornerstone of any long-term successful innovation or growth strategy. To achieve these dual goals (customer engagement and growth), an organization must be best-in-class in three key areas: understanding demand, nurturing the brand, differentiating from the competition. This three-fold approach to successful entrepreneurship is explored further below.

8 The Intersection between 360-Degree Research and Best Practices Awards Research Methodology Frost & Sullivan s 360-degree research methodology represents the analytical rigor of our research process. It offers a 360-degree-view of industry challenges, trends, and issues by integrating all 7 of Frost & Sullivan's research methodologies. Too often, companies make important growth decisions based on a narrow understanding of their environment, leading to errors of both omission and commission. Successful growth strategies are founded on a thorough understanding of market, technical, economic, financial, customer, best practices, and demographic analyses. The integration of these research disciplines into the 360-degree research methodology provides an evaluation platform for benchmarking industry players and for identifying those performing at bestin-class levels. About Frost & Sullivan Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best in class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best practice models to drive the generation, evaluation and implementation of powerful growth strategies. Frost & Sullivan leverages almost 50 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 31 offices on six continents. To join our Growth Partnership, please visit DEGREE RESEARCH: SEEING ORDER IN THE CHAOS

Transforming CliniCal Trials: The ability to aggregate and Visualize Data Efficiently to make impactful Decisions

Transforming CliniCal Trials: The ability to aggregate and Visualize Data Efficiently to make impactful Decisions : The ability to aggregate and Visualize Data Efficiently to make impactful Decisions www.eclinicalsol.com White Paper Table of Contents Maximizing Your EDC Investment... 3 Emerging Trends in Data Collection...

More information

Why Monitoring Is More Than Just SDV

Why Monitoring Is More Than Just SDV Why Monitoring Is More Than Just SDV Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective owners. Copyright 2013 Medidata

More information

Infoset builds software and services to advantage business operations and improve patient s life

Infoset builds software and services to advantage business operations and improve patient s life Infoset builds software and services to advantage business operations and improve patient s life Clinical Data Management ecrf & EDC Patient Support Programs Medication Adherence Mobile e-health Big Data

More information

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities

More information

Clinical Training Management

Clinical Training Management Clinical Training Management Learning and Compliance for Clinical Research Helping to Fuel the Growth of CROs and Service Providers According to clinical researcher CenterWatch, the FDA and global regulatory

More information

Adopting Site Quality Management to Optimize Risk-Based Monitoring

Adopting Site Quality Management to Optimize Risk-Based Monitoring Adopting Site Quality Management to Optimize Risk-Based Monitoring Medidata and other marks used herein are trademarks of Medidata Solutions, Inc. All other trademarks are the property of their respective

More information

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH Martin Valania, Executive Director, Corporate QA and Compliance Introduction Pharmaceutical companies recognize the benefits of carefully managing

More information

FDA Regulation of Electronic Source Data in Clinical Investigations

FDA Regulation of Electronic Source Data in Clinical Investigations FDA Regulation of Electronic Source Data in Clinical Investigations Q1 Productions Second Annual Innovations in Clinical Data Management Conference, Arlington, VA Mahnu Davar Presented on Oct. 28, 2014

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE 20132014 INSERT COMPANY LOGO HERE 2014 Global 2013 North Distributed American Denial-of-Service SSL Certificate Mitigation Product Market Leadership Leadership Award Award Frost & Sullivan 2014 1 We Accelerate

More information

Clinical Data Management Overview

Clinical Data Management Overview The 2 nd Clinical Data Management Training Clinical Data Management Overview Andrew Taylor ( 安 泰 乐 ), M.S. Head of Clinical Data Management August 30, 2010 Learning Objectives Overview of Process Related

More information

An Introduction to Electronic Data Capture Software. Learn the basics to find the right system for your needs

An Introduction to Electronic Data Capture Software. Learn the basics to find the right system for your needs An Introduction to Electronic Data Capture Software Learn the basics to find the right system for your needs By Forte Research Systems Software to fit your clinical research needs Cloud-based clinical

More information

Avg cost of a complex trial $100mn. Avg cost per patient for a Phase III Study

Avg cost of a complex trial $100mn. Avg cost per patient for a Phase III Study 1 Industry Perspective Over the last several years, clinical research costs have sky rocketed while new drug approvals are at multi-year lows. Studies have become global in nature and more complex to manage

More information

KCR Data Management: Designed for Full Data Transparency

KCR Data Management: Designed for Full Data Transparency KCR Data Management: Designed for Full Data Transparency 6% Observational 4% Phase IV 2% Device 11% Phase I 28% Phase II 49% Phase III The quality of study data relies first and foremost on the quality

More information

through advances in risk-based

through advances in risk-based Insight brief Quintiles is a market leader with >100 risk-based monitoring studies Quintiles developed solutions that bring as much as 25% cost reduction over traditional trial execution approaches Transform

More information

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Electronic Source Data in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Electronic Source Data in Clinical Investigations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE 2013 2014 INSERT COMPANY LOGO HERE 2014 Global Network 2013 North Performance American Monitoring SSL Certificate and Cyber Security Customer Product Value Leadership Leadership Award Award Background

More information

How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program

How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program Presenter: Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company This presentation

More information

BEST PRACTICES RESEARCH

BEST PRACTICES RESEARCH Frost & Sullivan 2015 1 "We Accelerate Growth" Contents Background and Company Performance... 3 Industry Challenges... 3 Customer Impact and Business Impact... 4 Conclusion... 6 Significance of Customer

More information

Background and Company Performance... 3. Industry Challenges... 3. Product Family Attributes and Business Impact... 3. Conclusion...

Background and Company Performance... 3. Industry Challenges... 3. Product Family Attributes and Business Impact... 3. Conclusion... Contents Background and Company Performance... 3 Industry Challenges... 3 Product Family Attributes and Business Impact... 3 Conclusion... 6 Significance of Product Leadership... 6 Understanding Product

More information

INSERT COMPANY LOGO HERE. New Product Innovation Leadership Leadership Award Award

INSERT COMPANY LOGO HERE. New Product Innovation Leadership Leadership Award Award 2013 2014 INSERT COMPANY LOGO HERE 2014 North 2013 North American American Cloud SSL Management Certificate Platforms New Product Innovation Leadership Leadership Award Award Background and Company Performance

More information

INSERT COMPANY LOGO HERE. Solutions for Discrete Product Industries Leadership New Product Award Innovation Award

INSERT COMPANY LOGO HERE. Solutions for Discrete Product Industries Leadership New Product Award Innovation Award 2013 2014 INSERT COMPANY LOGO HERE 2014 Global Plant 2013 North Data Management American SSL and Certificate Quality Optimization Solutions for Discrete Product Industries Leadership New Product Award

More information

Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS

Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Clinical Data Management (Process and practical guide) Nguyen Thi My Huong, MD. PhD WHO/RHR/SIS Training Course in Sexual and Reproductive Health Research Geneva 2013 OUTLINE Overview of Clinical Data

More information

2015 Global PLM Services in Discrete Manufacturing Company of the Year Award

2015 Global PLM Services in Discrete Manufacturing Company of the Year Award 2015 2015 Global PLM Services in Discrete Manufacturing Company of the Year Award Frost & Sullivan 1 We Accelerate Growth Background and Company Performance Industry Challenges The industrial sector experienced

More information

Data Management Unit Research Institute for Health Sciences, Chiang Mai University

Data Management Unit Research Institute for Health Sciences, Chiang Mai University Data Management Unit Research Institute for Health Sciences, Chiang Mai University Clinical Data Management is the process of handling data from clinical trials. The inherent goal of any clinical data

More information

Final Guidance on Electronic Source Data in Clinical Investigations Promoting esource Data Capture

Final Guidance on Electronic Source Data in Clinical Investigations Promoting esource Data Capture Final Guidance on Electronic Source Data in Clinical Investigations Promoting esource Data Capture CDER Leonard Sacks, Office of Medical Policy Ron Fitzmartin, Office of Strategic Programs Jonathan Helfgott,

More information

OPERATIONALIZING EXCELLENCE IN THE GLOBAL REGULATORY SUBMISSIONS PROCESS

OPERATIONALIZING EXCELLENCE IN THE GLOBAL REGULATORY SUBMISSIONS PROCESS OPERATIONALIZING EXCELLENCE IN THE GLOBAL REGULATORY SUBMISSIONS PROCESS INTRODUCTION As life sciences companies face expiring patents and shrinking drug-development pipelines, it s never been more important

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE 20132014 INSERT COMPANY LOGO HERE 2014 North 2013 American North American Inbound SSL Contact Certificate Center Routing Product Market Leadership Leadership Award Award Frost & Sullivan 1 We Accelerate

More information

Needs, Providing Solutions

Needs, Providing Solutions Identifying Needs, Providing Solutions 1 I n d u s t r y The growth of medical research and the countless innovations coming from the pharmaceutical, biotechnology and medical device industry, has improved

More information

Data Management & Case Report Form Development in Clinical Trials. Introduction to the Principles and Practice of Clinical Research.

Data Management & Case Report Form Development in Clinical Trials. Introduction to the Principles and Practice of Clinical Research. Data Management & Case Report Form Development in Clinical Trials Introduction to the Principles and Practice of Clinical Research February 3, 2015 Marge Good, RN, MPH, OCN Nurse Consultant Division of

More information

Supplement to the Guidance for Electronic Data Capture in Clinical Trials

Supplement to the Guidance for Electronic Data Capture in Clinical Trials Supplement to the Guidance for Electronic Data Capture in Clinical Trials January 10, 2012 Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Note: The original language of this

More information

Monitoring Clinical Trials with a SAS Risk-Based Approach

Monitoring Clinical Trials with a SAS Risk-Based Approach Paper DH05 Monitoring Clinical Trials with a SAS Risk-Based Approach Laurie Rose, SAS, Cary, NC USA ABSTRACT With global regulatory encouragement, the life sciences industry is gaining momentum to embrace

More information

2015 Canadian Cellular M2M and IoT Market Leadership Award

2015 Canadian Cellular M2M and IoT Market Leadership Award 2015 Canadian Cellular M2M and IoT Market Leadership Award 2015 Contents Background and Company Performance... 3 Industry Challenges... 3 Market Leadership of Rogers Communications... 4 Conclusion... 6

More information

Risk based monitoring using integrated clinical development platform

Risk based monitoring using integrated clinical development platform Risk based monitoring using integrated clinical development platform Authors Sita Rama Swamy Peddiboyina Dr. Shailesh Vijay Joshi 1 Abstract Post FDA s final guidance on Risk Based Monitoring, Industry

More information

Introduction. The Evolution of the Data Management Role: The Clinical Data Liaison

Introduction. The Evolution of the Data Management Role: The Clinical Data Liaison Introduction The CDL is a new role that will become a standard in the industry for companies that want to make more efficient use of limited resources: time and money. A CDL is key in that he or she conducts

More information

End-to-End E-Clinical Coverage with Oracle Health Sciences InForm GTM

End-to-End E-Clinical Coverage with Oracle Health Sciences InForm GTM End-to-End E-Clinical Coverage with InForm GTM A Complete Solution for Global Clinical Trials The broad market acceptance of electronic data capture (EDC) technology, coupled with an industry moving toward

More information

Background and Company Performance... 3. Industry Challenges... 3. Product Family Attributes and Business Impact... 3. Conclusion...

Background and Company Performance... 3. Industry Challenges... 3. Product Family Attributes and Business Impact... 3. Conclusion... Contents Background and Company Performance... 3 Industry Challenges... 3 Product Family Attributes and Business Impact... 3 Conclusion... 5 Significance of Product Leadership... 6 Understanding Product

More information

An information platform that delivers clinical studies better, faster, safer and more cost effectively

An information platform that delivers clinical studies better, faster, safer and more cost effectively An information platform that delivers clinical studies better, faster, safer and more cost effectively Powering Process & Performance Proactively manage study start-up and execution Risk profile new sites

More information

2013 North American Physician Practice Management Customer Value Enhancement Award

2013 North American Physician Practice Management Customer Value Enhancement Award 2013 2013 North American Physician Practice Management Customer Value Enhancement Award 2013 Frost & Sullivan 1 We Accelerate Growth Customer Value Enhancement Award Physician Practice Management North

More information

AGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE

AGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE WHITE PAPER AGILE RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT SOLUTIONS: A RECIPE FOR SPEED, SIMPLICITY AND SERVICE Randomization is fundamental to clinical trials it enables treatment group balance, eliminates

More information

Data Management: Good Team Work is de sleutel tot succes!

Data Management: Good Team Work is de sleutel tot succes! Data Management: Good Team Work is de sleutel tot succes! Gerald Ruiter Senior Data Manager Topics Introduction Data Management Activities People Process Technology Clinical Data Management: introduction

More information

Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels.

Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels. Serious about safety. Seriously strategic about labeling. If you are serious about safety, you have to be seriously strategic about your labels. 02 Clintrak knows how: Strategically engineered. Quality

More information

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to

INTRODUCTION. This book offers a systematic, ten-step approach, from the decision to validate to INTRODUCTION This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software

More information

Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS

Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Clinical Data Management (Process and practical guide) Dr Nguyen Thi My Huong WHO/RHR/RCP/SIS Training Course in Sexual and Reproductive Health Research Geneva 2012 OUTLINE Clinical Data Management CDM

More information

BEST PRACTICES RESEARCH. 2014 North American Cloud Computing New Product Innovation Leadership Award

BEST PRACTICES RESEARCH. 2014 North American Cloud Computing New Product Innovation Leadership Award 2014 2014 North American Cloud Computing New Product Innovation Leadership Award 1 Background and Company Performance Industry Challenges Cloud computing technology has enabled enterprises to use computer

More information

GCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS

GCP INSPECTORS WORKING GROUP <DRAFT> REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS European Medicines Agency London, 17 October 2007 Doc. Ref. EMEA/505620/2007 GCP INSPECTORS WORKING GROUP REFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALS

More information

eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Drug Supply Chain Forms Library Data Collection Services

eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Drug Supply Chain Forms Library Data Collection Services eclinical Services Predictable Pricing Full Service EDC Phase I-IV Sophisticated Edit Checks Data Collection Services Drug Supply Chain Forms Library Real-time Data Access Clinical Data Management Electronic

More information

Challenges and Opportunities in Clinical Trial Data Processing

Challenges and Opportunities in Clinical Trial Data Processing Challenges and Opportunities in Clinical Trial Data Processing Vadim Tantsyura, Olive Yuan, Ph.D. Sergiy Sirichenko (Regeneron Pharmaceuticals, Inc., Tarrytown, NY) PG 225 Introduction The review and approval

More information

2015 Global DOCSIS Cable Networks New Product Innovation Award

2015 Global DOCSIS Cable Networks New Product Innovation Award 2015 2015 Global DOCSIS Cable Networks New Product Innovation Award Frost & Sullivan 1 We Accelerate Growth Contents Background and Company Performance... 3 Industry Challenges... 3 New Product Attributes

More information

Guidance for Industry Computerized Systems Used in Clinical Investigations

Guidance for Industry Computerized Systems Used in Clinical Investigations Guidance for Industry Computerized Systems Used in Clinical Investigations U.S. Department of Health and Human Services Food and Drug Administration (FDA) Office of the Commissioner (OC) May 2007 Guidance

More information

ICH CRA Certification Guide March 2009

ICH CRA Certification Guide March 2009 ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS

More information

Stockholm, September 22 nd 2015. Rules, Regulations and Requirements

Stockholm, September 22 nd 2015. Rules, Regulations and Requirements Stockholm, September 22 nd 2015 Rules, Regulations and Requirements Presentation Objectives To describe the regulatory environment applicable to the use of electronic data in clinical trials To give a

More information

Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials

Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials 09 June 2010 EMA/INS/GCP/454280/2010 GCP Inspectors Working Group (GCP IWG) Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical

More information

New Product Product Innovation Leadership Leadership Award

New Product Product Innovation Leadership Leadership Award 2013 2014 INSERT COMPANY LOGO HERE 2014 North 2013 North American American Gallium SSL Nitride-based Certificate Devices New Product Product Innovation Leadership Leadership Award Award Frost & Sullivan

More information

BEST PRACTICES RESEARCH

BEST PRACTICES RESEARCH Frost & Sullivan 2015 1 We Accelerate Growth Contents Background and Company Performance... 3 Industry Challenges... 3 Product Family Attributes and Business Impact... 3 Conclusion... 7 Significance of

More information

Managing & Validating Research Data

Managing & Validating Research Data Research Management Standard Operating Procedure ISOP-H02 VERSION / REVISION: 2.0 EFFECTIVE DATE: 01 03 12 REVIEW DATE: 01 03 14 AUTHOR(S): CONTROLLER(S): APPROVED BY: Information Officer; NBT Clinical

More information

2015 Global Performance Monitoring for Network Operators New Product Innovation Award

2015 Global Performance Monitoring for Network Operators New Product Innovation Award 2015 Global Performance Monitoring for Network Operators New Product Innovation Award 2015 Contents Background and Company Performance... 3 Industry Challenges... 3 New Product Attributes and Customer

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE 2013 2015 INSERT COMPANY LOGO HERE 2015 Global 2013 Network North American Visibility and SSL Network Certificate Intelligence Company Product Leadership of the Year Award Contents Background and Company

More information

2015 South African Cloud Based Solutions to the Contact Centre Product Leadership Award

2015 South African Cloud Based Solutions to the Contact Centre Product Leadership Award 2015 2015 South African Cloud Based Solutions to the Contact Centre Product Leadership Award Contents Background and Company Performance... 3 Industry Challenges... 3 Implementation Excellence... 4 Product

More information

Clinical database/ecrf validation: effective processes and procedures

Clinical database/ecrf validation: effective processes and procedures TITOLO SLIDE Testo Slide Testo Slide Testo Slide Clinical database/ecrf validation: effective processes and procedures IV BIAS ANNUAL CONGRESS Padova September, 26 th 2012 PQE WORKSHOP: What's new in Computerized

More information

Services Competitive Product Strategy Leadership Innovation Award and Leadership Award

Services Competitive Product Strategy Leadership Innovation Award and Leadership Award 2013 2014 2014 Global Governmental 2013 North American Online Voting SSL Certificate and Election Modernization Services Competitive Product Strategy Leadership Innovation Award and Leadership Award Frost

More information

BEST PRACTICES RESEARCH INSERT COMPANY LOGO HERE

BEST PRACTICES RESEARCH INSERT COMPANY LOGO HERE 2013 2014 INSERT COMPANY LOGO HERE 2014 Global Automation Software for Real-time Operational 2013 North American SSL Certificate Intelligence Company of the Year Award Product Leadership Award Background

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE 2013 2014 INSERT COMPANY LOGO HERE 20142013 Global North Marketing American Automation SSL Certificate Software Entrepreneurial Product Company Leadership of Award the Year Award Entrepreneurial Company

More information

2015 Russian Nanotechnology Investment Enabling Technology Leadership Award

2015 Russian Nanotechnology Investment Enabling Technology Leadership Award 2015 Russian Nanotechnology Investment Enabling Technology Leadership Award 2015 Contents Background and Company Performance... 3 Technology Leverage and Customer Impact of OJSC RUSNANO... 3-5 Conclusion...

More information

Use of Electronic Health Record Data in Clinical Investigations

Use of Electronic Health Record Data in Clinical Investigations Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding

More information

2015 North American Business Metro Carrier Ethernet Services Market Leadership Award

2015 North American Business Metro Carrier Ethernet Services Market Leadership Award 2015 2015 North American Business Metro Carrier Ethernet Services Market Leadership Award Frost & Sullivan 2015 1 We Accelerate Growth Contents Industry Overview... 3 Market Leadership of AT&T... 3 Conclusion...

More information

Leveraging SharePoint for Clinical Trial Management

Leveraging SharePoint for Clinical Trial Management Bringing your projects to a higher level SM Leveraging SharePoint for Clinical Trial Management 26 April 2011 Presented by Darcy Vieira, Cato Research Canada Jeremiah Rehm, BioClinica 1 2010 by Cato Research

More information

Development of Case Report Forms

Development of Case Report Forms Development of Case Report Forms Introduction to the Principles and Practice of Clinical Research February 12, 2013 Diane St. Germain, RN, MS Nurse Consultant Division of Cancer Prevention National Cancer

More information

www.bioclinica.com Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS

www.bioclinica.com Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS Global clinical trial solutions. Real-world results. Imaging Core Lab Solutions Electronic Data Capture Clinical Trial Supply Planning IWR/IVRS Clinical Trial Management Clinical Data Management www.bioclinica.com

More information

2012 North American Email Content Security Product Differentiation Excellence Award

2012 North American Email Content Security Product Differentiation Excellence Award 2012 2012 North American Email Content Security Product Differentiation Excellence Award 2012 Frost & Sullivan 1 We Accelerate Growth Product Differentiation Excellence Award Email Content Security North

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE INSERT COMPANY LOGO HERE Frost & Sullivan 1 We Accelerate Growth Industry Challenges As cloud solutions and technologies evolve, enterprises continue to show interest in how the cloud can help them achieve

More information

BEST PRACTICES RESEARCH

BEST PRACTICES RESEARCH 2013 Frost & Sullivan 1 We Accelerate Growth Entrepreneurial Company of the Year Award Pharmaceutical Knowledge Process Outsourcing North America, 2013 Frost & Sullivan s Global Research Platform Frost

More information

Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA

Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA Barnett International and CHI's Inaugural Clinical Trial Oversight Summit June 4-7, 2012 Omni Parker House Boston, MA This presentation is the property of DynPort Vaccine Company LLC, a CSC company, and

More information

DATA MANAGEMENT OF GLOBAL CLINICAL TRIALS

DATA MANAGEMENT OF GLOBAL CLINICAL TRIALS DATA MANAGEMENT OF GLOBAL CLINICAL TRIALS Jeanne Ashton, Executive Director, Data Management Introduction Clinical data management and data quality are key strategic assets of large pharmaceutical companies

More information

Clinical Trial Coding: Overcoming the Challenges through Automation within Electronic Data Capture Applications

Clinical Trial Coding: Overcoming the Challenges through Automation within Electronic Data Capture Applications WHITE PAPER Clinical Trial : Overcoming the Challenges through Automation within Electronic Data Capture Applications WHITE PAPER Abstract: This paper reviews the issues surrounding the clinical trial

More information

INSERT COMPANY LOGO HERE

INSERT COMPANY LOGO HERE 201 3 2014 INSERT COMPANY LOGO HERE 2014 2013 North North American American Airway SSL Management Certificate Devices Product Product Leadership Leadership Award Award Frost & Sullivan 1 We Accelerate

More information

What is necessary to provide good clinical data for a clinical trial?

What is necessary to provide good clinical data for a clinical trial? What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction

More information

HESI: Fetal Imaging Workshop 21 CFR Part 11 Electronic Records & Signatures. Presented by: Jonathan S. Helfgott

HESI: Fetal Imaging Workshop 21 CFR Part 11 Electronic Records & Signatures. Presented by: Jonathan S. Helfgott HESI: Fetal Imaging Workshop 21 CFR Part 11 Electronic Records & Signatures Presented by: Jonathan S. Helfgott Director of Regulatory Affairs, Stage 2 Innovations Jonathan@stage2innovations.com Disclaimer

More information

ORACLE CLINICAL. Globalization. Flexibility. Efficiency. Competition ORACLE DATA SHEET OVERVIEW ROBUST CLINICAL DATA MANAGEMENT SOLUTION

ORACLE CLINICAL. Globalization. Flexibility. Efficiency. Competition ORACLE DATA SHEET OVERVIEW ROBUST CLINICAL DATA MANAGEMENT SOLUTION ORACLE CLINICAL OVERVIEW ROBUST CLINICAL DATA MANAGEMENT SOLUTION Smoothly transition from paper to EDC trials Annotated CRFs provides an intuitive means of creating submission-ready annotations Improved

More information

2015 European Coronary Stent New Product Innovation Award

2015 European Coronary Stent New Product Innovation Award 2015 European Coronary Stent New Product Innovation Award 2015 Contents Background and Company Performance... 3 Industry Challenges... 3 New Product Attributes and Customer Impact... 3 Conclusion... 4

More information

BEST PRACTICES RESEARCH

BEST PRACTICES RESEARCH Contents Background and Company Performance... 3 Industry Challenges... 3 Vertical Communications' Customer and Business Impact... 3 Conclusion... 5 Understanding Customer Value Leadership... 6 Key Benchmarking

More information

Organization Profile. IT Services

Organization Profile. IT Services Introduction In today s scientific and medical world, various issues in clinical trials and research have permeated every society and every field in medicine. Ethics and in particular the quality of research

More information

Aligning Quality Management Processes to Compliance Goals

Aligning Quality Management Processes to Compliance Goals Aligning Quality Management Processes to Compliance Goals MetricStream.com Smart Consulting Group Joint Webinar February 23 rd 2012 Nigel J. Smart, Ph.D. Smart Consulting Group 20 E. Market Street West

More information

MAKE THE SWITCH TO ELECTRONIC DATA CAPTURE

MAKE THE SWITCH TO ELECTRONIC DATA CAPTURE MAKE THE SWITCH TO ELECTRONIC DATA CAPTURE Sophie McCallum, Director of Operations, Clinovo INTRODUCTION Electronic Data Capture (EDC) collects clinical trial data electronically rather than on paper.

More information

2014 United Kingdom Infrastructure as a Service Customer Value Leadership Award

2014 United Kingdom Infrastructure as a Service Customer Value Leadership Award 2014 United Kingdom Infrastructure as a Service Customer Value Leadership Award Customer Value Leadership Award Infrastructure as a Service UNITED KINGDOM Background and Company Performance Industry Challenges

More information

2015 Global Identity and Access Management (IAM) Market Leadership Award

2015 Global Identity and Access Management (IAM) Market Leadership Award 2015 Global Identity and Access Management (IAM) Market Leadership Award 2015 Contents Background and Company Performance... 3 Industry Challenges... 3 Market Leadership of IBM... 3 Conclusion... 6 Significance

More information

Bringing Order to Your Clinical Data Making it Manageable and Meaningful

Bringing Order to Your Clinical Data Making it Manageable and Meaningful CLINICAL DATA MANAGEMENT Bringing Order to Your Clinical Data Making it Manageable and Meaningful eclinicalsol.com DATA IS SIMPLY BEAUTIFUL DATA STACKS IN STANDARD FORMATION This imaginative visual suggests

More information

2015 Global Fingerprint Biometrics for Mobile Devices Customer Value Leadership Award

2015 Global Fingerprint Biometrics for Mobile Devices Customer Value Leadership Award 2015 2015 Global Fingerprint Biometrics for Mobile Devices Customer Value Leadership Award Frost & Sullivan 1 We Accelerate Growth Contents Background and Company Performance... 2 Industry Challenges...

More information

2015 European Traditional Carsharing Customer Value Leadership Award

2015 European Traditional Carsharing Customer Value Leadership Award 2015 European Traditional Carsharing Customer Value Leadership Award 2015 Contents Background and Company Performance... 3 Industry Challenges... 3 Customer Impact and Business Impact... 3 Conclusion...

More information

Technology and Expertise Add Operational Value to Medical Device Trials

Technology and Expertise Add Operational Value to Medical Device Trials Technology and Expertise Add Operational Value to Medical Device Trials Copyright 2015 Medidata Solutions. Medidata Solutions and other trademarks reserved in the US and globally. Medidata and other marks

More information

Remote Monitoring of Clinical Trials and EMRs

Remote Monitoring of Clinical Trials and EMRs Remote Monitoring of Clinical Trials and EMRs Sandra SAM Sather, MS, BSN, CCRA, CCRC Vice-President Clinical Pathways LLC samsather@clinicalpathwaysresearch.com Lindsey Spangler, J.D. Associate Director,

More information

DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS

DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS Reference Number: UHB 139 Version Number: 2 Date of Next Review: 14 Apr 2018 Previous Trust/LHB Reference Number: N/A DATA MANAGEMENT IN CLINICAL TRIALS: GUIDELINES FOR RESEARCHERS Introduction and Aim

More information

datalabs edc REvolutionizing clinical data management

datalabs edc REvolutionizing clinical data management datalabs edc REvolutionizing clinical data management Since 2002, the DataLabs EDC solution has been helping many biopharmaceutical sponsors, clinical research organizations (CROs) and medical device manufacturers

More information

INSERT COMPANY LOGO HERE. 2015 Global Network Deployment and Field Service Emerging Company of the Year Award

INSERT COMPANY LOGO HERE. 2015 Global Network Deployment and Field Service Emerging Company of the Year Award 2015 INSERT COMPANY LOGO HERE 2015 Global Network Deployment and Field Service Emerging Company of the Year Award Contents Background and Company Performance... 3 Industry Challenges... 3 Visionary Innovation

More information

Managing and Integrating Clinical Trial Data: A Challenge for Pharma and their CRO Partners

Managing and Integrating Clinical Trial Data: A Challenge for Pharma and their CRO Partners Managing and Integrating Clinical Trial Data: A Challenge for Pharma and their CRO Partners Within the Pharmaceutical Industry, nothing is more fundamental to business success than bringing drugs and medical

More information

The Role of the CRO in Effective Risk-Based Monitoring

The Role of the CRO in Effective Risk-Based Monitoring New Whitepaper The Role of the CRO in Effective Risk-Based Monitoring The clinical trial industry is evolving. In an effort to improve participant safety and data integrity, regulators are encouraging

More information

Streamline Your Radiology Workflow. With Radiology Information Systems (RIS) and EHR

Streamline Your Radiology Workflow. With Radiology Information Systems (RIS) and EHR Streamline Your Radiology Workflow With Radiology Information Systems (RIS) and EHR 2 Practicing medicine effectively requires transferring large amounts of information quickly, accurately, and securely.

More information