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World eClinical Trials Markets
Frost & Sullivan, Jan 2006
Increasing Adoption of eClinical Technologies across the Organisation Poses a Major Challenge
The implementation of eClinical technologies (ECT) in pharmaceutical companies has been largely restricted to pilot projects till date, despite the growing recognition that information technology systems have tremendous potential in improving the productivity of drug research and development. One of the biggest challenges facing ECT vendors is the need to create an enterprise-wide momentum for implementing these technologies because it is only then that companies can fully realise the economies of scale and earn proper return on investment. However, with different clinical teams in an organisation having varied needs, the real challenge for ECT vendors is to integrate these requirements to develop a common solution. This is likely to be a difficult task, considering that vendors will first have to convince the entire organisation about the benefits of changing its clinical trials process.
This Frost & Sullivan research provides a comprehensive overview of the emerging eClinical trials market and its fast-growing potential in the drug discovery industry. It includes a detailed discussion of key market drivers and restraints as well as major challenges and strategic recommendations. The research also provides an analysis of the market’s competitive structure.
Continued Pressure on the Drug Pipeline Accelerates Search for Tools to Boost Drug Research Productivity
With dwindling drug pipelines, expiring patents of blockbuster drugs and a lack of potential blockbuster drug launches, the pharmaceuticals industry is actively seeking tools that can hasten the drug discovery process and enhance productivity. While ongoing research is expected to identify more drug candidates, the increase in clinical resources might not be sufficient to meet the growing number of candidates that are likely to move eventually from the pre-clinical to the clinical trials stage. This is likely to promote the implementation of ECT technologies.
'eClinical technologies allow the data to be analysed in real time and can be used to make a Go-No Go decision much faster, thus eliminating any waste in investments,' remarks the analyst of this research. 'Additionally, the increased quality and ability to validate the data in real time helps in cutting down time-consuming validation checks, which in turn translates into greater revenues due to the early introduction of drugs into the market.'
Increased Regulatory Acceptance Further Drives Adoption
The Food and Drug Administration (FDA) recently announced in its ‘Critical Path Initiative’ that it was actively considering electronic submissions as the way ahead to reduce current approval times. This announcement is helping raise acceptance of ECT technologies even among those in the drug discovery industry that had expressed doubts about these technologies earlier. Regulatory acceptance of clinical data standards by organisations such as Clinical Data Interchange Standards Consortium (CDISC) is also helping promote the uptake of ECT by allowing greater integration of data standards.
'With the regulatory companies believing that electronic submissions will increase the productivity of the present approval process, there is a definite motivation towards the e way,' says the analyst. 'Lifescience companies have been investing huge amounts of money in developing infrastructure for e-clinical trials, electronic submissions and electronic patient diaries as well as for converting their paper-based processes into electronic ones.'
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