The following paper discusses the challenges of tracking global disclosure performance and how clinical trial sponsors can use Atlas Global Compliance to manage track and reduce the risks of non‐compliance.
Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.
A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).
This paper looks at clinical trial transparency and the driving forces behind it to better understand the role of technology in the execution of a solid clinical trial transparency policy.
The Sponsor’s current system required redundant data entry, consisted of disjointed tools, and was a drain on valuable resources.
To address non-compliance and improve the ratio of completed trials with results, we recommend the following two-step process to take control of your compliance.
Maintaining disclosure compliance is tricky enough with ClinicalTrials.gov, but when it comes to EU CTR compliance, the complexity rises to a whole new level. As a sponsor, do you find your organization “guilty” of these common errors?
A video overview of the valuable content that can be accessed as a DIA NOW user.
Don't let the complex logistics involved in the handling of clinical supplies in certain regions of the world put your patients at risk or jeopardize both the study budget and timeline.
How technology-based imaging improves quality and regulatory compliance, and how these improvements benefit sponsors.
In this webinar, INC Research/inVentiv Health experts discuss the factors that sponsors must take into account as they design and execute clinical trials in this space, beginning with a review of the immunotherapy landscape.
See how a life sciences organization uses CoSign to securely and compliantly sign an FDA form.
When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.
TrialScope Clinical Trial Transparency Service (CTTS) enables clinical trial sponsors to engage with patients and the public via a user-friendly, high impact website to openly share clinical trial information and results, demonstrating leadership in transparency while optimizing trial recruitment and retention.
PharmaCM is a clinical trial disclosure platform designed specifically for the regulated environment of Life Sciences. PharmaCM is used to manage the complex process of authoring, reviewing, editing, approving and publishing clinical trial application and disclosure data. Disclosure content is very dynamic. Clinical trial data is constantly being updated, modified and formatted for specific registries such as ClinicalTrials.gov and EudraCT.