Advanced Clinical Research

More than 80,000 clinical trials alone are conducted in the United States per year and about 95% of them are still paper-based. So it is not surprising that as life sciences organizations seek ways to drive efficiency and improve performance, one of the areas most closely scrutinized is the clinical development process. Although technological developments have enabled life sciences organizations to gather, process, and communicate clinical trial information more quickly, most of the information technology investments have been in point solutions, applications that address requirements to a particular point in the process. In other words, companies have simply adapted their existing systems to meet the new challenges rather than revising the clinical process as a whole. As a result, some organizations may have between 25 and 30 software applications requiring integration, support, and maintenance.

Data collection and management currently account for up to 60% of the overall clinical trial process, a timeline that drug companies increasingly find unacceptable as they face increasing pressures to test, approve, and market new drugs faster than ever before. Introducing an integrated content management solution to automate the documentation process relevant to clinical trials and related activities can help cut the time for these trials by two-thirds.

HepTronik Clinical Trials streamlines the clinical trial process by capturing, authoring, processing, and managing clinical documentation. By standardizing, controlling, and securing clinical trials-related content, HepTronik Clinical Trials reduces the costs of data acquisition and clean up during trials, enables real-time decision-making based on immediately accessible data, and ensures regulatory compliance and faster submission preparation.

Clinical trial operations management has relied on an inefficient combination of manual paper-based procedures and a variety of non-descriptive and in-housed developed software applications. Typically, software applications were implemented as self-contained, point solutions with little in the way of design considerations for integration with other applications or business processes that are traversed functional areas. More generic product means more competition in off patent market. More competition in off-patent market means more low-price products. More low-price products in off-patent market mean more resources for innovative products.

More innovative products to be generated mean early identification for candidate for drug research.

Therefore the issues mentioned above puts a great importance for quick turnaround of the studies, to prudently use the financial and human resources without repeating to do the same things again and again.

The use of electronic data interchange and the internet as an effective and secure mechanism for data transportation, information sharing, and collaboration have been achieved across number of critical financial and manufacturing sectors with a velocity that suggests it safe for the clinical trial entities to move aggressively, effectively and more forcefully.

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