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European Pharmaceutical Contractor

Introducing e-Clinical Trial Systems Toda

Are you Transferring to e-Trials?

When looking at the landscape of current clinical research we find a great mixture of companies in research, CROs as well as industry start-ups, with e-trials starting to appear more frequently.

Only very few companies have implemented electronic data capture (EDC) and electronic study management services as their standard clinical trial technology. The new technology is handed over from pilot to pilot. However wherever the EDC provider looks, companies and people are becoming ready to fully commit to e-trials in the near future.

Another look at the strange experiences relating to the introduction of electronic systems and services within clinical trials reveals that many people have used EDC once and - whilst not having a negative experience - are not convinced enough to use it in the next trial. The advantages proven and presented by vendors and suppliers often trickle away somewhere in the complex setting of a clinical trial. This is strange considering the technology to which users retreat is - in the eyes of an IT professional - extraordinarily old fashioned. The case can only be compared with travel by car being excelled by someone travelling on horseback from town to town. When looking at several years of electronic data capture we will see that this analogy is rather apt.


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By Dr Max Horneck, Chief Technical Officer at clinIT AG

Dr Max Horneck has been with Dr Kцhler GmbH in Freiburg for over 10 years. After graduating in Cognitive Science, he set up and maintained the IT systems of a modern clinical data management company. In 1996 Dr Horneck started to develop systems for remote data entry and implemented TRI@L-IT V.1 1998 as a web based solution for data collection.

In 2001 the IT department of Dr Kцhler GmbH was spun out and emerged as clinIT AG, a company delivering IT services for clinical research such as EDC with TRI@L-IT V.2 and automated telephone systems for patient allocation. Dr Horneck is now the company's Chief Technical Officer. TRI@L-IT has now proven its advantages in about 20 clinical trials involving more than 5,000 patients all over the world.

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Dr Max Horneck
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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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Azopharma Announces Plans to Implement XcelodoseTM Technology in the Production of Early Stage Clinical Trial Materials

HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today plans to implement Xcelodose technology at its formulations development facility, ApiCross Drug Delivery Technologies. Xcelodose technology is a powder micro-dosing system developed by Meridica. This technology offers a unique powder dispensing system for small-scale capsule filling and ultimately assists in conserving valuable research material as well as reducing various Preformulation activities.
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