21 CFR Part 11 & CDISC FDA - Medrio, Inc.go.medrio.com/rs/medrio/images/Illustrated History of...
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1-800-498-6830 [email protected] © 2015 Medrio, Inc. San Francisco, CA 345 California St, Ste 325 The majority of research sponsors will move to cloud-based build-it-yourself solutions as industry recognizes the time and cost-saving benefits of this approach. eSource will become the standard data entry method, saving study sponsors millions of dollars in data entry and monitoring costs. Risk-based monitoring will become the default monitoring method. Mobile technology will help virtualize the clinical trial process such that more data may be collected remotely through mobile applications and wearable health devices rather than in person. Present The Future of EDC Based on recent trends, industry experts predict that within the next 50 years... References: 1 NextDocs report. (2014). “State of Trial Master Files (TMF).” http://www.nextdocs.com/project/clinical-resources/ 2 Campbell Alliance (2012). “Realizing the Promise of Electronic Data Capture: A Practical Guide.” http://www.campbellalliance.com/articles/Realiz- ing_the_Promise_of_Clinical_EDC_A_Practical_Guide.pdf 3 Handelsman, D (2008). “Evolution of SAS in Life Sciences Research and Development.” SAS Global Forum. http://www2.sas.com/proceedings/forum2008/205-2008.pdf 4 2014 FDA Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Standardized Study Data. 2010’s As technology progressed, a number of key innova- tions followed, including: ePRO technology, which allowed study subjects to enter data from home; risk-based monitoring, which has become a largely accepted method for data oversight; and more advanced reporting tools, including more sophisticated analytics and data visualization functionality. More Advanced EDC 2005 Medrio developed the first cloud-based EDC software. With Medrio CloudEDC TM , data collection was fully hosted in the cloud for the first time in clinical research. This meant that companies no longer needed their own on-premise infrastructure to use EDC. Plus, Medrio’s cutting edge do-it- yourself functionality allowed researchers to quickly and easily build their own custom studies through a drag-and-drop interface, thus reducing costs and study start-up time. Medrio Builds 1st Cloud EDC 1997 Prompted by the FDA’s issuance of 21 CFR Part 11, a consortium of life science companies collaborated to form CDISC, an organization that aims to define global standards for information systems in clinical research. CDISC standards have since gained broad acceptance. So much so that The FDA has mandated that all submissions be CDISC compliant by 2017. 4 21 CFR Part 11 & CDISC The FDA issued 21 CFR Part 11 in March 1997. With this regulation, the FDA began accepting electronic records and electronic signatures as valid alternatives to paper records and handwritten signatures for the first time. FDA CDISC 1990’s With the rise of the internet, electronic data capture (EDC) was born. Unlike RDE, EDC software was not installed locally on a computer’s hardware; instead, it was hosted on a server that could be accessed through the web by many computers at once. Sharing computing resources in this way made EDC drastically more time and cost efficient than RDE. But this benefit was not enjoyed by everyone, as many companies could not afford the necessary servers and infrastructure to implement EDC. Early EDC C D E 1980’s With the advent of personal computers, clinicians were finally able to enter data directly at the research site. They used a data collection tool called Remote Data Entry (RDE), which, unlike EDC, was installed locally on a computer’s hardware. Data was transmitted to the sponsor via phone line. Remote Data Entry (RDE) 1970’s Mainframes at the Clinic With sponsors entering data in one place and clinicians collecting data in another, there were many logistical challenges. Some institutions took action by installing large mainframe computers at research sites so that clinicians could take charge of data entry. While this solution worked, it was much too costly and labor-intensive for most companies. Information was collected on paper forms and physically delivered to the research sponsor. Sponsors entered the data into databases hosted on early mainframe computers such as the IBM Sytstem/360. Paper & Snail Mail 1960’s An Illustrated History of EDC An estimated 70% of active clinical trials today use electronic data capture (EDC). 1 Companies choose to use EDC over paper data collection to benefit from fewer manual queries, shortened timelines, and reduced costs. 2 But few people know the interesting history of how EDC evolved over the past five decades. Explore our infographic timeline to learn about the major events in EDC’s evolution from the 1960’s to today. Brought to you by Medrio CloudEDC TM
Transcript of 21 CFR Part 11 & CDISC FDA - Medrio, Inc.go.medrio.com/rs/medrio/images/Illustrated History of...
1-800-498-6830 [email protected] © 2015 Medrio, Inc. San Francisco, CA
345 California St, Ste 325
The majority of research sponsors will move to cloud-based build-it-yourself solutions as industry recognizes the time and cost-saving benefits of this approach.
eSource will become the standard data entry method, saving study sponsors millions of dollars in data entry and monitoring costs.
Risk-based monitoring will become the default monitoring method.
Mobile technology will help virtualize the clinical trial process such that more data may be collected remotely through mobile applications and wearable health devices rather than in person.
Present
The Future of EDCBased on recent trends, industry experts predict that within the next 50 years...
References:1 NextDocs report. (2014). “State of Trial Master Files (TMF).” http://www.nextdocs.com/project/clinical-resources/2 Campbell Alliance (2012). “Realizing the Promise of Electronic Data Capture: A Practical Guide.”http://www.campbellalliance.com/articles/Realiz-ing_the_Promise_of_Clinical_EDC_A_Practical_Guide.pdf3 Handelsman, D (2008). “Evolution of SAS in Life Sciences Research and Development.” SAS Global Forum.http://www2.sas.com/proceedings/forum2008/205-2008.pdf4 2014 FDA Draft Guidance for Industry: Providing Regulatory Submissions in Electronic Format — Standardized Study Data.
2010’s
As technology progressed, a number of key innova-tions followed, including: ePRO technology, which allowed study subjects to enter data from home; risk-based monitoring, which has become a largely accepted method for data oversight; and more advanced reporting tools, including more sophisticated analytics and data visualization functionality.
More Advanced EDC
2005
Medrio developed the first cloud-based EDC software. With Medrio CloudEDCTM, data collection was fully hosted in the cloud for the first time in clinical research. This meant that companies no longer needed their own on-premise infrastructure to use EDC. Plus, Medrio’s cutting edge do-it- yourself functionality allowed researchers to quickly and easily build their own custom studies through a drag-and-drop interface, thus reducing costs and study start-up time.
Medrio Builds 1st Cloud EDC
1997
Prompted by the FDA’s issuance of 21 CFR Part 11, a consortium of life science companies collaborated to form CDISC, an organization that aims to define global standards for information systems in clinical research. CDISC standards have since gained broad acceptance. So much so that The FDA has mandated that all submissions be CDISC compliant by 2017.4
21 CFR Part 11 & CDISC
The FDA issued 21 CFR Part 11 in March 1997. With this regulation, the FDA began accepting electronic records and electronic signatures as valid alternatives to paper records and handwritten signatures for the first time.
FDA
CDISC
1990’s
With the rise of the internet, electronic data capture (EDC) was born. Unlike RDE, EDC software was not installed locally on a computer’s hardware; instead, it was hosted on a server that could be accessed through the web by many computers at once. Sharing computing resources in this way made EDC drastically more time and cost efficient than RDE. But this benefit was not enjoyed by everyone, as many companies could not afford the necessary servers and infrastructure to implement EDC.
Early EDC
CD
E
1980’s
With the advent of personal computers, clinicians were finally able to enter data directly at the research site. They used a data collection tool called Remote Data Entry (RDE), which, unlike EDC, was installed locally on a computer’s hardware. Data was transmitted to the sponsor via phone line.
Remote Data Entry (RDE)
1970’s Mainframes at the Clinic
With sponsors entering data in one place and clinicians collecting data in another, there were many logistical challenges. Some institutions took action by installing large mainframe computers at research sites so that clinicians could take charge of data entry. While this solution worked, it was much too costly and labor-intensive for most companies.
Information was collected on paper forms and physically delivered to the research sponsor. Sponsors entered the data into databases hosted on early mainframe computers such as the IBM Sytstem/360.
Paper & Snail Mail 1960’s
An Illustrated History of EDC
An estimated 70% of active clinical trials today use electronic data capture (EDC).1 Companies choose to use EDC over paper data collection to benefit from fewer manual queries, shortened timelines, and reduced costs.2 But few people know the interesting history of how EDC evolved over the past five decades. Explore our infographic timeline to learn about the major events in EDC’s evolution from the 1960’s to today.
Brought to you byMedrio CloudEDCTM
