ArisGlobal Releases agClinical 3.3

Sets New Benchmark for Transparency and Compliance in Clinical Trial Management

Chicago, IL - ArisGlobal, a leading provider of integrated, cloud-based software solutions for life sciences, announces agClinical 3.3, the latest version of its comprehensive clinical trial management software. This release further enables life science organizations to confidently and efficiently meet new compliance and submission requirements, improve risk-based monitoring and better manage the electronic trial master file so that compliance is assured and transparency is improved.

"We benefit from a collaborative relationship with our customers, and we have taken their valued, best-practices input and added new functionality to our already comprehensive solution to position our customers for success," said David Laky, ArisGlobal's General Manager and VP, Clinical Development. "We are confident that agClinical 3.3 responds to their need for reducing the labor-intensive aspects of clinical trial management."

agClinical 3.3 includes:

• Global Trial Submissions: Important new features that support global trial submissions irrespective of region, country or regulations in support of Clinical Trial Regulation (EU) No 536/2014.

• Enhanced Automation Leads to Increased Efficiency of Clinical Research Associates (CRAs): Enhanced capabilities to automate the monitoring process which will increase the efficiency of Clinical Research Associates (CRAs). Including remote monitoring enhancements, a new mobile monitoring module, Microsoft Outlook integration, e-signed confirmation letter, follow-up letter and workflow based monitoring that publish approved artifacts to eTMF that automates the entire monitoring process.

• RACT Tool: Risk Assessment Categorization Tool as defined by TransCelerate. This tool enables organizations to develop and implement risk mitigation plans by identifying and entering information for key risk factors resulting in more efficient operations and the ability to monitor risk through key risk indicators.

• Improved Document Management: Advanced functionality and usability improvements to the integrated electronic trial master file (eTMF), unified within agClinical, driving companies to meet and exceed document management obligations.

• Portal with Advanced Functionalities: An advanced Investigator and Site portal that tracks, onboarding, Investigator scoring, key study metrics, enables document sharing, and tracks payment milestones and financial obligations.

• Robust Third-Party Integration: Further enhancements to our already robust third-party integration tools and APIs (application program interface). The enhanced middleware acts as a Clinical Backend as a Service (CBaaS) enabling organizations to integrate with their systems of choice. Our library of connectors already includes a growing number of EDC (electronic data capture) and document management systems as well as the ability to connect to our own market leading products.

"Clinical trials are highly regulated, complex undertakings," said Sonia Veluchamy, ArisGlobal Managing Director. "agClinical is recognized by customers and analysts as one of the most functionally-rich CTMS solutions on the market. This newest version further solidifies our position as the leader in this splintered market."

About ArisGlobal
ArisGlobal's cloud-based solutions facilitate global drug development and regulatory compliance in the life sciences and healthcare industries across the entire product life cycle including clinical development, regulatory affairs, safety and pharmacovigilance and medical communications. Hundreds of drug and device manufacturers, CROs and regulatory agencies leverage ArisGlobal's advanced technology solutions spanning regulatory information management, pharmacovigilance regulatory reporting, medical information and clinical trial management software to make better and more informed decisions, facilitate compliance, reduce risk, and improve operational efficiency. Headquartered in the United States, ArisGlobal has regional offices in Europe, India and Japan. For more information, visit arisglobal.com, or follow ArisGlobal on LinkedIn and Twitter.