Effective with this issue, we are delighted to bring you a third installment of eCliniqua every month. Our intent is not merely to increase the quantity of our informative reports and interviews, but to expand the scope of eCliniqua, pushing into new areas of e-clinical research.

In the third issue each month, we look forward to taking a closer look at a range of management and operational issues surrounding the implementation of e-clinical technology solutions and innovations. How does the adoption and integration of new technology impact management decision-making, the process of implementation and performance? And what are the challenges and opportunities of the globalization trend on the e-clinical enterprise?

We invite your comments and feedback for this and our regular editions of eCliniqua. We also welcome proposals from all readers for guest commentaries on topics of broad interest to the e-clinical industry to appear in eCliniqua.

The Editors

Currently, the Gaithersburg and Beijing labs are undergoing an integration process.  CEO and President Glenn Rice explains, "Over the next two months, both labs will be operating under a single set of SOPs [standard operation procedures], and both will provide the same staff training, to be conducted onsite and online."  In most cases, this will lead to various certifications of the technicians, such as the ones offered by the American Association for Laboratory Animal Science (AALAS).  In addition, a single point of contact is being established for each critical function such as financial management, contract management, report writing, regulatory, and instrument calibration.  There is one set of validated computer systems, with data downloaded nightly into a secure Oracle database in the US with hard copy backup in China maintained by DataSafe.
 
The goal is not to make the Gaithersburg and Beijing labs identical, but rather to have both operate at a US level of GLP compliance and able to perform all of the services needed to complete an IND.  Beyond that, the company intends to differentiate the two labs by offering some separate services at each.  "China will mostly offer research services and standard toxicology with a specialization in primates, whereas the US lab will continue to focus on more advanced toxicology services, teratology, and assay development in reproductive toxicology, carcinogenicity testing, and advanced safety pharmacology," says Rice.

There will be some overlapping services, however, giving clients a choice.  "Bids coming out of China are approximately 50 percent less than those coming out of the US," Rice says.  The obvious question is - won't clients automatically opt to have pre-clinical lab work done in the Beijing site because of the dramatic cost savings?  Not really, claims Rice, who explains that there are still some holes to be filled in the Chinese level of operations, particularly in quality assurance, project management, and other ancillary skills sets.   

"We're making a big investment in China in both capital equipment and training, $10.5 million in the first eighteen months," Rice says.  Interestingly, when it comes to informatics, he ranks the Beijing lab as ahead of Gaithersburg.  To standardize it with the level of Beijing, Bridge is currently investing $500,000 in technology in Gaithersburg, implementing and validating Instem's Provantis 8, a data collection and management solution, and investing an equal amount in training costs.

Several years ago, investigative sites were almost unanimously frustrated by the unmet promises of clinical trial technology solutions. Today, sites appear far more receptive to the conceptual importance of these solutions, but many feel that they are entering into a commitment to adopt them without much support from research sponsors. Fully embracing technology adoption could trigger potentially disastrous consequences: A significant proportion of investigative sites using e-clinical trial (eCT) technology solutions face increased workload and higher volunteer drop-out rates.

eCT technology solutions are supposed to facilitate efficiencies. But their use is often producing the opposite affect: More than one out of four investigative sites reports that their workload increases when eCT solutions are used. Investigative sites are quick to point out the two primary culprits:

1. Lack of technical support; and
2. Incompatibility between sponsor data collection systems.

In turn, many investigative sites are reluctantly and cautiously adopting eCT technology solutions, often relying on paper-based approaches as an insurance policy against inevitable problems.

According to a survey conducted by the Clinical Data Interchange Standards Consortium (CDISC), most investigative sites have prepared themselves for eCT. Almost all sites report having dedicated staff now trained on electronic case report form (eCRF) and electronic patient-reported outcome (ePRO) systems. More than half of sites report having developed standard operating procedures (SOPs) specific to e-clinical trials.

But technical support is one of the largest aggravations for investigative sites. Most sites want to see more responsive technical support, and find that sponsors are rarely helpful even when they are available to answer technical questions. Since, according to sites, most questions have a technical component as well as a protocol-specific component, study staff must contact multiple sponsor representatives to get one question answered. In the absence of technical support, research sponsors face delays and extra costs; and investigative sites face delayed payments for work performed.

Investigative sites typically must turn to the study coordinator to handle technical problems -- an individual who is often the least equipped to handle troubleshooting. Some sites report that even when an actual Help Desk has been established by the sponsor, the person manning the desk is often unable to respond to inquiries. Worst of all, when study volunteers face technical problems that cannot be resolved, they blame the site directly and may even choose to drop out of the study. Based on interviews with clinical investigators, poorer volunteer retention rates are a common occurrence when eCT technology solutions are involved.

Investigative sites remain adamant that sponsors should collaborate to better standardize data collection systems, if only to reduce the mounting number of incompatible desktop and laptop terminals. Investigative sites have an average of three disparate systems to capture transcribed CRF data. Many of the most active sites report having as many as six to ten disparate systems. Many investigative sites report that their offices have become cluttered IT jungles, requiring unreasonable levels of allocated space and staff training programs. With increasing turnover among study coordinators, investigators and site managers face an additional challenge of having to rapidly train new staff to stay on top of electronic data collection activity.

For sponsors, a primary objective of drug development today is to conduct clinical research more efficiently while improving patient safety. In order to do so, it is imperative that sponsors recognize and meet the critical need to provide more effective technical support and higher levels of compatibility to their investigative sites.

Kenneth Getz is co-founder and Board Chair of CISCRP, and the founder and former CEO of CenterWatch.