Applied Clinical Trials

Supplements-02-02-2005, Volume 0, Issue 0

Have your subjects record electronic information in blue ink with Health Decisions' writing instrument.

Have your subjects record electronic information in blue ink with Health Decisions' writing instrument

Health Decisions

(Chapel Hill, NC) is far from the only company that will have some pens at their booth at the next conference. But no other pen will be able to practically double as a PDA.

Tools for Clinical Trials Professionals

Its Smart Pen is a distinct difference to all of the other EDC products available. Most require subjects to either enter their data electronically or fill out a form, which is then entered into a database for them. The Smart Pen lets patients fill out a form, and then have the pen itself transmit the recorded data via a cradle to the database.

How? Each specialized form used as a CRF is light gray: that's actually a tiny grid of boxes. The pen records which boxes are touched by the pen strokes with a miniature camera, and then turns that into handwriting analysis. Dock the pen in its recharger/cradle to send the information to your database. Any irregularities in the data are immediately shown to the site, which can correct them against the paper copy. The pen also creates an exact copy of the CRF to be saved online.

Health Decisions is a full-service CRO, and offers other methods of collecting information that aren't as space age as the Smart Pen.

Health Decisions, (919) 967-1111,

One little acronym converts your Oracle Clinical database of trial information for FDA submission

CSS Informatics'

(Cambridge, MA) new product, OC2SDS, may sound like an drug discovered by an array, but its usefulness extends for every type of drug or device being tested for FDA approval.

Smart Pen™

OC2SDS converts data from Oracle Clinical files into SAS Version 5 transport files—the software's name is an acronym describing the process. Version 5 meets the latest standards of the Clinical Data Interchange Standards Consortium.

Converting a simple trial is relatively easy—the true test comes from the complicated trials. OC2SDS comes with utilities to map source views to a single target domain, create new mapping views, convert items, create new domains, and map oracle values to controlled CDISC terminology.

When the magic is done, users will be left with a perfectly acceptable xml metadata file, exactly as FDA requested. Sponsors' attention can be focused on analyzing and interpreting trial data, instead of wondering how that data will be sent to one of the Offices of New Drug Evaluation.

CSS is a division of PPD Inc. (Wil-mington, NC), which provides dozens of services to help a compound become a drug, and a drug come to market.


CSS Informatics, (617) 868-6878.

A new program in ICTS's suite makes sure the all-important Q-word— quality—gets the respect it deserves

Integrated Clinical Trial Services

(Raleigh, NC) was founded in 2003 to maximize the patient enrollment process for CROs, sites, and sponsors. One of the ways it is accomplishing this is through its new Integrated e-Q™ program.

ICTS offers platforms to help develop a clinical trial's patient recruitment in a host of ways. Media planning, call center planning, education, compliance, community resources, investigator relations, and even concept design and creative services are available from ICTS.

Integrated e-Q, then, is designed to get the most from each of these elements of patent recruitment. e-Q, a Web-based program, makes sure that each aspect of your project is going as planned, from the physician referrals to the SMO work to the retention and compliance programs. It also ensures that other members of the team are as up-to-date as you are with "My Pages," which lists tasks.

Integrated e-Q™

ICTS already uses the quality assurance suite in-house, and is now offering it to third parties. Making sure all work is of high quality is a sure way to reduce time and costs of a trial.

Integrated Clinical Trial Services, (919) 388-3964,