PRA streamlines clinical data management

By Kirsty Barnes

- Last updated on GMT

Related tags Clinical trial Clinical data acquisition Pharmaceutical industry Edc

PRA International has been busy implementing an advanced data
management system as part of a number of new internal measures
aimed at improving operating efficiency and cutting the costs of
clinical trials.

Developed by DataLabs Clinical using Microsoft software, the Flex DMS can be used for electronic data capture (EDC), but can also be used to convert paper data entry into an electronic format.

The new solution allows users to design a clinical study once; collect the data either through paper data entry (PDE), EDC or a combination of formats; and then clean and manage the data using the same system and virtually the same process.

While EDC is rapidly gaining acceptance among the medical investigator community, paper reporting is still the dominant data collection method used so there is still a real need to manage paper reporting in clinical trials as efficiently as possible.

"We are expecting the Flex DMS to produce savings in the time and costs involved with running clinical trials although at this stage it is too early to quantify these savings,"​ company spokesperson, John Lewis told

Since April PRA has been rolling out the Flex DMS to its clients on a gradual basis and currently has 20 clinical trials that are in various stages of development using technology.

"From now on though it will be used by all of our clients globally, but to what degree it is used for EDC will vary and is dependant largely on the investigators using the system,"​ said Lewis.

"Although trial sponsors can try to encourage the use of EDC, many clinicians are still not comfortable using computers and many investigator sites throughout the world are not adequately set up for EDC yet either."

Earlier this year PRA saw its first quarter profits tumble on the back of a major contract loss, coupled with ongoing delays in its biotech contracts, and the company has been introducing several new project efficiency measures, of which Flex DMS is one, as well as focusing on increasing its international presence in order improve its financial performance.

So far the move seems to be paying off - PRA's Flex DMS was last week awarded Microsoft's Pharmaceutical and Life Science Technology Innovation Award in the Clinical Development category.

Related news

Show more

Related products

show more

SDTM supplemental qualifiers explained

SDTM supplemental qualifiers explained

Content provided by Formedix | 12-May-2023 | White Paper

What are SDTM supplemental qualifiers? In short, these are variables in non-CDISC datasets that cannot be mapped to a variable that matches the SDTM standard....

How clinical trial software can optimize trials

How clinical trial software can optimize trials

Content provided by Formedix | 17-Apr-2023 | White Paper

Companies often have to conduct multiple clinical trials at the same time, which means they've got to be efficient, and compliant with industry regulations....

4 Warning Signs Your Research Site Is in Trouble

4 Warning Signs Your Research Site Is in Trouble

Content provided by Elligo Health Research® | 13-Apr-2023 | Insight Guide

You want your clinical research practice to be a success for your business and your patients, but how can you tell if it’s in trouble? Read this article...

ODM and CDASH in CRF design

ODM and CDASH in CRF design

Content provided by Formedix | 10-Mar-2023 | White Paper

The lesser-known Operational Data Model (ODM) standard is often overlooked as it's not required by any regulators. So, why should you be interested...

Related suppliers

Follow us


View more