All electronic solutions for clinical trials are not the same, and simply possessing the technology does not mean providing a service, says electronic clinical trials firm
Clinical Technology organisation ClinPhone is urging pharmaceutical and biotechnology companies to demand guarantees of experience and ability from vendors offering IVRS and web-based clinical trial management solutions, or face the consequences of having to transfer the trial.
The recommendation comes after the company was approached to take on its 15th trial transfer, and tenth in the last two years, following technical problems with the sponsors' original vendor.
Since the company was founded in 1993 ClinPhone itself has managed more than 750 clinical trials with no mid-study transfers to any other provider.
ClinPhone provides electronic clinical trial management solutions, including its market-leading Interactive Voice Response (IVR) services and innovative randomisation and medication management solutions to the global clinical trials industry.
Its systems are regarded as the industry standard for improving electronic trial management and process workflow.
The company is soon to roll-out a new portfolio of complementary services, including Interactive Web Response (IWR), a trial supplies simulation and forecasting service called MedSim and a specialist consultancy service for complex randomisations. "It's a worrying trend," commented ClinPhone managing director Jonathan Engler.
"All vendors appear similar on the surface.
Sponsors, however, must focus on what happens behind the web form or behind the telephone call and look closely at how events are logged, how audit trails are developed and retained, how projects are supported and the commitment to providing end users with true 24/7 support.
"The vendor system in this latest case was not only performing randomisation but also data collection that would feed the clinical database. The system was 100% web-based and had a number of known 21 CFR part 11 compliance issues as well as security issues.
"In reality, the possession of IVR technology accounts for only about 10% of the delivery of a successful service in a clinical trial setting.
The other 90% comes in the form of experience, reliable and robust systems, delivery of support, flexibility in protocol development, commitment to quality management and a virtual obsession with audit and event logging.
The solution? "Sponsors need to stop looking at IVR technology as if it was a central pathology laboratory," added Dr Engler. "We are dealing with systems that are absolutely critical to the correct allocation of treatment and dosing of patients participating in a clinical protocol costing in many cases, several millions of dollars to conduct.
The value of different systems can only be compared by looking at the differing costs on a risk-adjusted basis.
"Quality comes at a cost and our message is simple.
Why risk your protocol by adopting an outsourcing policy based on cost rather than quality and performance? When it goes wrong, the net result is always the same - unexpected costs incurred in the development of other systems, in the transfer of data and in the implementation of new systems with their investigative sites.
For many smaller sponsors, the financial commitment means they only get a single chance to get it right and run a study to conclusion.
"If any component fails then the consequences can be serious." ClinPhone employs more than 330 people worldwide and as well as its New Jersey facility, has offices in Chicago and San Francisco in the United States, European offices in Brussels and Heidelberg and its global headquarters in Nottingham.
It is now the largest and most experienced industry specialist in global e-clinical trial management, having supported more than 750 clinical trials in over 80 countries and 70 languages and is set to roll out further new services over the coming year.
