|
 |
| home > epc > winter 2001 > electronic data capture - achieving the promise of more efficient trials |
|
|
 PUBLICATIONS |
European Pharmaceutical Contractor
|
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.
|
Read full article >>
|
|
 |
|
| Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | | |
|
|
 |
Industry Events |
 |
ICSE Europe
5-7 October 2010, Paris, France
ICSE is the international stage for companies providing outsourcing services in clinical trials, contract research, custom manufacturing, biotechnology, IT, analytical services, packaging services and logistics. For over 10 years, ICSE has been connecting buyers and sellers in the market of (bio)pharmaceutical and pharma-related contract services. With a keen eye for new needs and new developments, each ICSE event is set up to fulfil its role as meeting place and intermediary as effectively as possible.
More info >> |
|
 |
News and Press Releases |
 |
ClinTec International
ClinTec International, a global Clinical Research Organisation (“CRO”) announces a financial and strategic partnership with Elephant Capital Plc., an AIM market listed private equity firm. With an investment of £8 Million GBP, Elephant has acquired a significant minority stake in ClinTec. Through this investment, Elephant has entered the attractive clinical research base, where ClinTec operates as a global provider of outsourcing solutions addressing the drug development lifecycle. Managing Partner of Elephant Capital LLP, Gaurav Burman, and Non-Executive Director of Elephant Capital Plc, James Hauslein, have also made personal co-investments in this transaction.
More info >> |
|
 |
