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Surveys Scale Up EClinical References Presentations Reports/Documents Articles/Publications

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Only selected knowledge of the eClinical Forum is available within the public domain. All information is available free to members (eClinical Forum Membership)

Surveys

EDC Metrics Survey 2004

Available:

Jun 2004

Price:

Free Download Report  714k zip Download Questionnaire  280k zip

The eClinical Forum has recently conducted a internal survey of companies involved in conducting EDC trials to assess the feasibility of establishing standard metrics for the assessment of EDC performance.

The survey covered:

• General characteristics of the company and EDC adoption
• Clinical Research volumes Performance data for Trials Past First Patient In in last 12 months
• Performance data for Trials Past Database Lock in last 12 months

16 completed questionnaires were returned by both Pharma companies (86%) and CROs (14%), providing data on 51 trials past First Patient In and 34 trials past Database Lock

Parameters have been ranked by frequency of response within each category to provide an indication of the availability for benchmarking purposes

A first set of benchmarking data is available to determine the current, actual performance of EDC trials across the industry

Further work is being considered by the eCF to build upon the success of the feasibility testThe eClinical Forum has recently conducted a global survey of investigational site experiences and expectations with EDC.

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Investigator Survey 2000

Available:

Jan 2003

Price:

Free Download Report  480k zip Download Questionnaire  190k zip

The eClinical Forum has recently conducted a global survey of investigational site experiences and expectations with EDC. The survey covered:

• Computer use and site facilities
• Current experience with EDC
• Satisfaction with features of EDC
• Future expectations

840 completed questionnaires were returned by both EDC experienced (52%) and EDC naïve (48%) investigators. The results show:

• In the EDC experienced population over 40% of current trials use EDC.
• Although there are significant differences between continents, investigators are very computer literate with even 20-30% of EDC naïve investigators using Email and Internet several times a day.
• Investigators find data entry a burden that should ideally be shifted to other site staff.
• Despite investigators wanting to improve the speed of data entry, only 13% of data is first entered into the eCRF. The main opportunity to improve speed of entry lies in avoiding duplication of entry into both EDC and patient records.
• Gaps exist between investigator need and level of satisfaction with speed of communication, tools for study management, direct data transfer and resources for data entry.
• Most EDC experienced investigators consider that EDC should be used for all trials and over 50% of investigators say that the availability of EDC will positively affect their decision to participate in trials.

 The results show interesting issues and trends that the eClinical Forum will be exploring further (link to presentations)

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Industry Survey 1999

Available:

July 2000

Price:

Free Download Report 400k pdf

A survey was undertaken by the eClinical Forum to review the pharmaceutical industry’s experience to date with Electronic Data Capture (EDC) and to better understand the trends for the future.

The survey report incorporates the responses of 30 companies, and includes a mixture of EU and US ethical pharmaceutical and biotechnology companies representing 8 of the top 10, 12 of the top 20 and 18 of the top 40 by revenue.

The survey assessed the positions of the respondents in the following areas:

• The electronic data collection technologies currently in use
• The extent of internal and external development of systems
• The percentage of clinical studies that have been conducted using EDC during the last 12 months
• The expectations and achievements of EDC in the areas of development time, cost, quality and capacity.
• The areas of re-design that were conducted in parallel to the implementation of EDC
• An assessment of EDC experience to date
• EDC technologies being considered for future use
• The percentage of clinical trials that will be conducted using EDC by the year 2000 and 2005
• Issues with current vendor products and services
• Issues and concerns with EDC 
• Additional information and experience

A copy of the survey report is available free.

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Scale-Up

Scale Up Handbook

Available:

Q4 2001

Price:

On request

A handbook consolidating the experience of eClinical Forum members has been developed. Information is available on request.

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Last Updated: June 05, 2008 .