Summary
Headquartered in the UK and with operations based in the US, GSK are Pharmaceutical industry leaders. As a company with a firm foundation in science, GSK have strong research focus and a track record of turning that research into powerful, marketable drugs. Every hour GSK spend more than £300,000 (US$562,000) to find new medicines.
GSK worked with Mekon to develop a new solution for their CRF (Clinical Research Form) process which has fulfilled their needs for over a decade (since 1998, with minor updates implemented as recently as 2009 to implement new 3rd party software updates). Mekon worked both with SmithKline Beecham (SB) and Glaxo Wellcome independently to deliver similar solutions. This was before their merger to form GSK in January 2000, to form what was at the time largest drug company in the world as well as the UK’s largest company outright.
The SmithKline Beecham project was the more complex solution, but post-merger, the simpler Glaxo system became the primary live production system.
After winning a Request For Proposal tender process to replace a non-Y2K compliant legacy system, Mekon did a requirements review, setting up a list of system functional requirements that included and exceeded the base expectations.
Key Issues
SmithKline Beecham (SB), like many pharmaceutical manufacturing and research companies, had to conform to important legislative rules in the pursuit of business. One such requirement is the collection of drug trials on new products which is carried out using Clinical Research Forms (CRFs, also know as Case Report Forms) where the patient and physician record all the events and effects that are observed during drug testing.
The forms can be 50 or 250 pages in size – filling an entire A4 binder – with various parts printed on 3 part duplicating NCR (‘no carbon required’ duplication format) paper.
- SB created CRFs in a ‘CRF design department’ and then sent content down to a print department who would put in manual effort controlling what kind of paper was use for what pages on a page-by-page basis.
- 3 part NCR (‘no carbon required’ duplication format) page printing requirements meant lots of manual effort in the print department to deliver the right pages on the right types of paper.
- Each page of each set of forms needed unique patient-specific identification printed on all pages ensure the data collected could always be traced back to its source.
- Then there was the mammoth task of converting all the key CRFs used by SmithKline Beecham into a new format. Over 22,000 pages in 18 languages needed to be converted to comply with the strict pharmaceutical regulations together with over 2000 frequently used pages to speed production and consistency
Solution
Mekon provided consultancy, which led to our creation of advanced templates, reference pages, and unique fonts to allow SB to rapidly create their CRF's in the future.
Mekon used the FrameMaker Development Kit (FDK) to create custom functionality that provided CRF Designers with the facilities required, including:
- A creation application which turned the authoring tool into a complete ‘control center’ for the creation process, automating functions that SB hadn’t realised were possible. Using ‘eJob cards’ to replace the old instruction sheets that were sent to the print department, meaning advanced printing control was moved into the hands of the author, driven from their authoring tool.
- This drove automatic paper selection using Xerox high volume printers. Postscript codes were inserted automatically into output stream to tell the printer what to do.
- Various re-usable controlled data entry forms to compile forms from a bank of ‘research form question types’
- Sequential patient number insertion during printing
- Specialised page numbering requirements
- Many more automation and usability enhancements
This package of developments provides SB with a simple and speedy clinical research form (CRF) creation and printing solution.
SB also received content conversion services for the 22,000 pages of content in their legacy library.
Staff were provided with customised solution training, including FrameMaker, on location in the US and at their UK offices, together with on-going technical support provided by Mekon's in-house support staff. The training programme included the correct use of their custom templates and the methodology used in publishing regulatory documentation to maximise the benefits of the solution.
The Glaxo, system was similar, but not as sophisticated. Since the focus of delivery moved to PDF the simpler Glaxo application became the primary.
Benefits
Automation of complex publishing tasks means:
- An intercontinental team successfully transferred and trained on a new more automatic system
- New ROI opportunities identified and implemented for increased efficiencies – even beyond what the RFP asked
- Faster throughput from the departments
- Better consistency with compliance to complex data-field format, page, and form-numbering standards
In the Customer's Words
“The Data Capture Technologies group has enjoyed working with Mekon and I would have no hesitation in recommending them to you. Throughout the project, Mekon adopted a proactive approach and quickly became a full member of the Project Team.
“They gained a detailed knowledge of our requirements relating to CRF production and consequently developed an innovative bespoke solution that has resulted in significant reduction in the complexity of both document structure and printing.”
- G R Darley, Team Manager, Data Capture Technologies, Biostatistics and Data Sciences, GSK
