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THE PHARMA REVIEW (MAY - JUNE 2011)

E Clinical Trials: Oppurunities And Prospects

Uday Venkat Mateti, Tarachand Lalwani, Isukapalli Sameera, Murgundi, PM and Anantha N N

Introduction
Conventionally clinical trials are very complex and demands high precision data which is subjected to scrutiny at various stages and levels. As it is multi activity, and the objective is to learn whether the drug is safe and effective for human use. Earlier in absence of E-clinical trials several truck load of document had to submitted for the regulatory authorities, who would scrutinize and get convinced that the trials were conducted as per the norms and outcomes are having minimum bias and are trust worthy which guarantees the safety and efficacy of the product under study. The Activity of clinical trials is given in Figure 1.
Earlier clinical trials were labour some, highly expensive and regulators always had the doubt regarding the data being manipulated or the results may be misleading in the matter of safety. The long time required to complete the trial always increased the costs for the sponsors. Due to the requirement of huge finance and time the adaptation of information technology is not only obvious but also necessary. As the sponsors are interested to push the time scale and make it most cost effective integration of disciplines like management, information technology and health sciences has taken place. The new style of participation of regulatory authorities during the performance of clinical trial itself is in the interest of sponsor and regulators as this would fill the trust gap and ensure effective communication of clinical trials.
In the early days of E-clinical trials, the pharmaceutical industry was quite conservative in its use of the technology owing to concerns over the security of data and the safety of intellectual property. E-clinical trial was also very costly to implement, with companies having to invest in large amounts of hardware and training, not to mention the license cost. However, times are changing. Developments in information technology have enabled E-clinical trials to be offered at a lower cost than ever before, allowing increased access to the technology. Now, many companies are reliant on E-clinical to manage numerous trials. With this reliance has come the demand for information and ease of access to this information so that CROs can make rapid business decisions. This demand is what has necessitated pushing E-clinical tools to a new level of performance, use, and scalability. In addition, the concept of transparency between the client and CRO is paramount.

 

 

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