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| home > epc > winter 2001 > electronic data capture - achieving the promise of more efficient trials |
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European Pharmaceutical Contractor
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Internet-enabled electronic data management solutions allow for the electronic capture, storage and near real-time availability of data from multiple locations, whilst promising optimal efficiency in the entire clinical trial process. Wireless solutions extend these capabilities, allowing patients to submit quality of life and other data in real-time and from any location, as well as providing a mechanism for improving patient compliance. With vendors claiming that they can revolutionise the entire clinical trial process, potential clients must stop and examine the feasibility of these claims. Additionally, in order for companies to realise a return on investment into expensive data capture platforms, employee training must encompass and enable all issues impacting the full integration of electronic data capture and management. This is a feat yet to be realised by many.
The Current State of Clinical Trials Data Management
Research has found that in 2000, only five to 10 per cent of clinical trials were electronically enabled. The more widely used paper-based system can lead to both time delays and quality problems. Included in the paper-based process is the manual design and distribution of paper case report forms (CRFs). There are thousands of these paper forms which increases the possibility of loss and damage. In collecting data, a physician or nurse examining the patient manually enters information into a CRF.
Errors, including ticking an incorrect box on a checklist, writing notes in random spaces or providing incomplete information are common. This information must then be transmitted from the investigator site to a sponsor site, during which time data may be intercepted or lost. Once at the sponsor site, data must be entered into the database by two separate people. The purpose of this resource-heavy process, known as double data entry, is to verify that mistakes are not made in transcribing information from the CRFs to the database.
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Industry Events |
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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.
More info >> |
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News and Press Releases |
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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.
More info >> |
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