Will biotech and pharmaceutical companies demand simpler technology solutions? Will they insist that systems are as easy to snap together as Lego blocks?

To explore which services and technology firms might facilitate such a shift, ClinPage decided to compile a list. All of the firms on our list are major providers of clinical trial services and technologies. It’s a start at identifying the most savvy, diversified firms supporting clinical trials.

Readers are encouraged to challenge names on the list or suggest firms that should be added to it. One word to describe these companies is suite. ClinPage has had an editorial department devoted to eclinical suites since this website’s launch two years ago.

Our Method

The crux of the matter is that some sponsors still prefer selecting the best possible clinical technology solution they can find, one category at a time. Then they knit that together with their other systems and data streams.

Now the tide is turning. Some companies are growing weary of the stitching. It’s the re-sewing that gets old. These companies are hoping for simpler solutions that can all use the same data from the same trial. Data standards from organizations like the Clinical Data Interchange Standards Consortium (CDISC) could go a long way toward making some integrations simpler. Companies like PharmaPros specialize in such projects.

In theory, some combination of standards and integration could save a great deal of pointless manual transfers of information from one system to another. Will sponsors just talk about integration and suites? Or actually demand them? That may be the $64,000 question.d9A2t49mkex

Our list constitutes a good-faith effort to identify integrated providers of multiple technologies in clinical trials. Some of the solutions listed are separate, standalone pieces of software. Others are more tightly connected mega-applications with a single user name and password needed to access everything.

At the risk of stating the obvious, companies must provide the technology in question. Partnering with some other firm doesn’t count. If a subsidiary or division of a company provides the technology or service, we list the parent company.

We also sought to highlight significant niches in the industry. We didn’t want to consider a Post-It-note-based system specifically designed for artificial hip trials in western Guatemala. Rather we wanted major technologies that appear to be in demand throughout the industry.

Tech-Service Convergence

So we only chose technologies that had three (3) easily recognizable providers, and technologies that were already offered by other firms in the chart. We also added a category for contract research organizations (CROs); some sponsors of clinical trials seem to want to deal with a CRO, and others seem to prefer dedicated technology specialists.

The list seems to validate one of this reporter’s few deeply held convictions—that the line between technology firms and CROs is not so stark, not so delineated. To some degree, whether they self-identify as such or not, all of the firms are CROs. Someone is bound to sue us over that statement but we needed to say it.

In the end, the nine categories we chose to evaluate are below, with links to the editorial departments on this site when applicable.

•CRO  (contract research organization with extensive services)
•CTMS (clinical trial management systems for managing recruitment, sites, investigators, payments)
•EDC (electronic data capture)
•EKG (systems for electrocardiograms and other cardiac data)
•ePRO (systems for patient-reported outcomes and patient diaries)
•Imaging (systems for handling radiological images)
•IVRS (interactive voice response systems for randomization, drug supply management)
•Regulatory (systems for managing eCTDs, trial master files, and other documents and submissions)
•Safety  (systems for adverse event reporting and management; and pharmacovigilance)

To review our unscientific methodology, such as it was, we included any firm, however large or obscure, that offered three of the above services and technologies. The top 20 clinical trial technology suites, in alphabetical order, turned out to be:

Almac
Aris Global
BioImaging Technologies
DataTrak International
ERT
etrials
i3 Global
Icon Clinical
Kendle International
MedNet Solutions
Octagon Research
Oracle Clinical
Parexel International
Pharmanet
Pharmavigilant
Phase Forward
Target Health
United Biosource
Velos
Worldwide Clinical Trials

For the record, some readers will notice we omitted systems for registries and Phase IV EDC, as well as clinical data management and warehouse solutions. We recognize the importance of those sectors. But we were are unsure of how much economic activity or technological change they represent. In some cases, the data in such systems is now routinely handled by EDC systems.

This article, as well as a handy PDF version of the list, will be amended, corrected and updated as needed. Comments? Contact the editor. Readers in the sponsor community are encouraged to share their wisdom. Truly. It will help our legal defense effort.

The article and PDF were most recently updated on February 17, 2009. Companies wishing to point out services or technologies of which the editor was previously not aware should email both a relevant hyperlink and a PDF product information sheet to for consideration.