"In eClinical trials (eCT), it is the human element of resistance to change that is the greatest challenge rather than the technology itself," said Frost & Sullivan's research analyst Raghavendra Chitta.
"This is why the majority of adoption, thus far, has been in the form of small pilot projects."
With lifescience and pharmaceutical companies showing a definite inclination towards electronic technologies and investing substantial amounts in transitioning from paper-based to electronic processes, revenues in the eClinical trials (eCT) market are expected to increase from approximately $210m (€177m) in 2004 to $357.4m in 2011.
However, barring a few implementations by some major pharmaceutical companies, the report identifies the area of most resistance stemming from research scientists in lifescience companies.
Shifting to eCT technologies would not only mean adapting to more technically sophisticated processes, but could also require a complete redistribution of roles and responsibilities.
Moreover, companies need to implement eCT technologies across their organisations for them to be successful. Implementing these technologies in isolation in a few clinical research teams will not yield the desired results.
Frost and Sullivan's report identifies the main task for eCT technology vendors is to convince all stakeholders in the clinical trials process to adopt and integrate these technologies across all teams within the organisation.
However, for vendors to be able to take adoption levels beyond the pilot stage and into enterprise-wide implementation, the real challenge is to provide a compelling return on investment (ROI) to lifescience and pharmaceutical companies.
"Since implementing eCT applications involves major expenditure for creating new infrastructure, changing the business processes, training and support, eCT vendors will have to develop sound ROI models and proof of concepts," said Chitta.
"The challenge for vendors is to identify the right kind of parameters and develop robust ROI models to substantiate their implementation."
Vendors must therefore work at leveraging the advantages gained by implementing eCT technologies, such as real-time availability of data, to increase their adoption.
Since the clinical trials process is electronics based, the patient data is entered into electronic media, which has real-time data validation checks, instead of in paper-based case report forms (CRF).
This process allows the data to be cleaned at the point of entry itself, which enables considerable savings in data entry and curing.
The report reckons that by reducing the time taken to transfer the data from the patient to the regulatory authority, electronics-based processes also help improve productivity to a great extent.
The report: "World eClinical Trials Market (B726-52)," is available now with further details available from Frost and Sullivan's website.