TrialAssure discounts pricing for academics: ‘It is crucial for universities to get it right’

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/noipornpan)
(Image: Getty/noipornpan)

Related tags TrialAssure Clinical trial reporting

The global software provider is discounting its reporting software for academics, as universities globally struggle with compliance and face increasing pressure to publish clinical trial results.

TrialAssure Academic Pricing (TAP) provides the company’s clinical trial registration and disclosure reporting application at a discounted price. The offering enables sponsors and academic researchers to manage the disclosure process, including registry assessments, validation and quality checks, review cycles, approvals, as well as comments from regulatory authorities.

“In an academic setting, it can be more difficult to obtain public-ready information from investigators and other contributors to the study. When a study completes, the primary focus is on analyzing results and getting published, with transparency obligations often taking a back seat,”​ Zach Weingarden, product solutions manager, TrialAssure, told us.

Between pharmaceutical companies and universities, Weingarden said the penalties are viewed differently.

He explained, “For pharma companies, there is the potential of fines of up to $10,000/day and the general poor stigma of being non-compliant or not transparent is bad for the company’s image. While that is also true for universities, the bigger issue is that most leading scientific journals require clinical trial disclosures be up-to-date or they will refuse to publish any of the results.”

Additionally, the National Institutes of Health (NIH) can withhold funding for other studies.

“These two areas are much more impactful for continued funding and research at the academic level, so it is crucial for universities to get it right,”​ added Weingarden.

Only 11% of universities post clinical trial results to the European Clinical Trial Register (EUCTR) within the required timeframe, according to a report published in The BMJ​.

Clamping down on compliance, the Chair of the Science and Technology Select Committee, Norman Lamb MP, recently wrote to more than forty UK universities​. The committee plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.

In the US, a study in BMC Medicine​ found that approximately 35% of universities have a policy addressing clinical trial results reporting and 74% do not have electronic transparency system to manage reporting.

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...

A Guide Through the API Drug Development Pipeline.

A Guide Through the API Drug Development Pipeline.

Content provided by Lonza Small Molecules | 04-Apr-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Related suppliers

Follow us


View more