FAQ’s

Here are some frequently asked questions about eClinical, the hybrid paper and electronic data capture (EDC) system for clinical trials.

Hopefully these will answer most of your questions but if you have any more complex questions or require further information, please do not hesitate to contact us.

Pre-project
How soon do we need to get you involved?

As early as possible in the development of the clinical trial and Standard Operating Procedures. Our experience and advice at the beginning not only speeds up the setup but also reduces the chance of having to change your forms a number of months down the line. It is important to get it right first time by anticipating any issues or stumbling blocks.

As our name suggests, we believe firmly in partnership. This means that we not only have the skills and resources to provide the means to address your data capture needs, but also continue to train and support your organisation, almost as if we are part of your data processing team. Our focus on fully understanding your requirements, offering seasoned advice during the project specification stage and our technical abilities and resources to implement the solution, all combine to allow us to exceed your expectations.

Can you advise on form design?

ePC can share decades of experience in designing forms for clinical trials with you. This means you can gain ideas and understand best practices that are tried and tested, meaning you can avoid the pitfalls and move directly to an efficient trial.

The aim is to ensure data is routinely recorded and readily available. Towards this end, UKTMN recommend that you make the form attractive and as easy as possible to complete. We suggest the development of trial branding, vibrant colours and simple tick boxes where possible to make the form as simple as possible to fill in. Constrained print boxes can be used to capture handwriting with open ended text boxes only used where the data being captured will be genuinely useful to the trial. The aim is to minimise free text fields to make the data more accurate and measurable. Clear writing and directions along with good layout will reduce the likelihood of errors and extra administration later on.

Is the system 21 CFR Part 11 compliant?

Whilst it is impossible to guarantee a software component will be 21 CFR Part 11 compliant when it is used within a much larger clinical trial system, it is certainly possible to use eClinical and TeleForm as part of a compliant system. Certain responsibilities of compliance rest upon the end user of the solution to implement robust and compliant procedures and methods. ePC can advise and ensure the end solution is compliant.

Will we need to change our existing forms to work with eClinical?

Our system works best with forms designed for automated data capture. Features such as corner stones are used to help the system orientate the form properly or barcodes to identify the form type and fields such as constrained print boxes aid swift recognition.

However, eClinical does include an existing form templating system, to allow your existing forms to be captured. This is useful if the forms are supplied by a client or you already have a large number of forms already in circulation that can not be changed.

How much does eClinical cost?

The launch of a new therapy can take many years and often cost millions in capital investment, so it pays to implement a robust and easy use data collection system.

As clinical trials must deliver in time and on budget, eClinical repays the initial investment by cutting the cost of clinical trial forms processing significantly whilst the accuracy and reliability of the system also brings peace of mind to Sponsors, Chief Investigators and trial team members alike.

Typical cost breakdown

The single user version of eClinical offers a complete clinical forms scanning and processing solution based on the following components:

  • TeleForm Desktop
  • Mid volume scanner
  • 1 day on site installation and configuration*
  • 1 day on site user training and handover*
  • 1 year technical support & maintenance including version upgrades

The total cost is: £10,380.

What are the optional extras?

  • eStore forms archiving and retrieval system** £3,995
  • High volume scanner £1,100
  • TeleForm Desktop eForms module** £3,995
  • TeleForm Workgroup multi-user upgrade** £7,000
  • TeleForm Workgroup eForms module** £5,995

* Plus travel expenses

**Plus support & maintenance at 23% of product cost per year.

Pricing for scanner maintenance (up to 4 hour response) and additional licenses for Workgroup systems available on request.

Pricing correct at time of publishing, EO&E.

Implementation
What are the IT and system requirements?

Our clinical trials scanning solutions run on industry standard Microsoft Windows hardware, software and networks. We can liaise with your IT team and suppliers to ensure compatibility, but any modern Windows based PC should be adequate. We would be happy to discuss specific requirements further if you contact us.

The basic requirements are as follows:

eClinical Desktop minimum system requirements

  • Modern i5 (or equivalent) processor or above
  • 4GB RAM
  • 20GB minimum free hard drive space
  • Microsoft Windows 10 or above
  • 1 free USB 2 (or above) port
  • 21″ SXGA monitor

eClinical Workgroup minimum requirements

Server:

  • Modern Xeon (or equivalent) processor or above
  • 8GB RAM
  • 20GB minimum free hard drive space
  • Microsoft Server 2012 or above
  • 100MBit TCP/IP non-routed network connection to workstations

Workstation:

  • As per eClinical Desktop minimum system requirements above

Scanner requirements

We support most industry standard TWAIN and ISIS scanners for image capture, but please see our capture page for recommendations.

How soon can you install a solution?

We have direct access to software and scanners allowing for swift delivery in a matter of days. Scheduling in development resources for form design, integration and training can take a little longer but we can still normally deliver this within a few weeks.

How quickly can the system read a form?

As a rule of thumb you can reduce a full day’s manual entry to less than half an hour. In our experience a form can take anything from 1 to 10 seconds to capture – only a few percent of the time it would take to manually enter the data.

The factors which govern this speed include the design of the form itself, the number of fields and the data checking rules applied.

What data checks and validations can be carried out to improve speed and accuracy?

Within the standard product we can check for alpha or numeric characters, we can confirm valid dates or numeric and date ranges. Mandatory fields and the presence of signatures along with dictionary checks and simple lookups to external databases for valid values are all easily setup with a few clicks of a wizard.

The built in VBA or .NET scripting can provide for more complex rules such as conditional rules dependant on entries in other fields or complex multi-field lookups to existing databases.

We have also implemented several additional modules to compliment eClinical. These include eSearch, for example, for validating names and addresses against the post code and electoral databases or bank account details against the Experian Payments Bank Wizard.

Can the system only read handwriting?

The system can recognise printed handwritten characters, machine print, bar codes, the presence of signatures and tick boxes.

TeleForm sounds great. What else can it be used for?

TeleForm is not just a clinical trials processing system. It is also an extremely powerful forms design and data capture system which allows you to create and extract data from any sort of structured form. Typical examples of alternative uses include questionnaires and surveys, application forms, expense claim forms, in fact any form that is to be filled in by hand and the results input into a computer system.

How many forms can I capture?

TeleForm doesn’t artificially restrict the numbers of forms you can capture, so the only limitation is how many you can physically scan and verify. On a single-user Desktop system, this could be from hundreds to thousands of pages per day and with the multi-user Workgroup and Enterprise systems providing capability for hundreds of thousands of pages per day!

The scanner you utilize will have a big impact on throughput, with smaller entry-level scanners capturing batches of 50 to 100 pages at a time with large production scanners able to scan 500 or even 750 pages at a time.

Training
What level of IT expertise required?

We understand eClinical will be used in both large organisations with dedicated IT staff and within smaller projects with limited IT resources. We are happy to document your entire end-to-end requirements, develop, test and install a fully working solution so that any IT literate user, armed with our training, will then be able to manage and run the system to capture and export thousands of trial forms.

Alternatively, if you have the IT resources, we are equally happy to deliver the software, possibly hardware, support and training to allow you to design forms and processes internally. This does not require a technical developer, but a good familiarity with Windows based IT systems and databases is helpful.

What kind of training is involved?

Although we have a range of courses designed for all aspects of the eClinical system, we are happy to tailor a course around your particular needs.

Our standard two day training course will give basic tuition on how to design your clinical trials form, how to scan and verify forms, how to create exports, and how to search and retrieve data using eStore.

Can we arrange it at our offices or coordinating centre?

Yes, we actually prefer to attend your site to give bespoke training on your actual system. This allows us to better understand your requirements and to customise some of the training to your forms.

How many people can we get trained?

As we usually give the training on your site, the maximum number of delegates is usually limited by the space and PC resources you have available. We can provide additional software and workstations if required, although this can take extra time to set up on your site. Typically, we can train four to six delegates sharing two or three PCs.

Resources
Are there any resources for Trial Managers?

Clinical Trials Toolkit

The Clinical Trials Toolkit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK. Through the use of an interactive routemap, this site provides information on best practice and outlines the current legal and practical requirements for conducting clinical trials.

Medical Research Council (MRC)

Information about the MRC which works to improve the health of people in the UK – and around the world – by supporting excellent science and training the very best scientists.

UK Clinical Research Collaboration (UKCRC)

The UK Clinical Research Collaboration (UKCRC) was developed to support clinical research and to promote randomised controlled trials in six key health areas.

ISRCTN registry

ISRCTN registry contains a database of ongoing trials in all areas of healthcare. About 20,000 trials are listed, which are taking place around the world. This database is aimed at researchers, but is freely accessible.

What after-sales support do you provide?

We have three types of support that we can provide to ensure your staff are empowered to get the most from eClinical.

Standard support & maintenance

Our standard technical support contract provides you with access to our permanently manned support desk during the hours of 9am – 5.30pm Monday to Friday, excluding public holidays. We have the experience and the resources to deal with any query you may have regarding your eClinical system.

We know that time is money so won’t keep you waiting in an automated phone queue! In addition to this, as long as you keep your support contract current, we provide free updates to the eClinical software, including full version upgrades as and when they become available.

Platinum support & maintenance

We recognise the critical nature of your trials form processing. Remember: No data – no trial – no outcome. To ensure against extended downtime we can provide remote systems management or extended hours support if required.

Scanner support & Maintenance

We can provide on-site or replacement support & maintenance for our range of scanners. We have down to four hour response times available with guaranteed fix or replacement scanner within a further four. The contract covers all labour and parts, excluding consumables.

If you want to learn more about hybrid paper and electronic data capture in clinical trials, or wish to book a demonstration, please contact us.

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Address: ePartner Consulting Ltd, PO Box 1578, Lightwater, GU22 2UY, United Kingdom. Tel: +44 (0)3300 100 000.

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