Enables secure global document sharing and community management tools for life sciences
Litera
announces the acquisition of AxxiTRIALS, a Clinical Trials Portal solution providing life science companies and clinical research organizations (CROs) with a platform designed to dramatically speed site start-up, patient recruitment, and end-to-end clinical trial operations.
"This acquisition is in keeping with Litera's continued strategic focus on secure, compliant collaboration and nicely aligns with our content management product portfolio," said Litera President Karen Massand. "We see AxxiTRIALS, with its emphasis on outstanding user interface, community building and engagement tools, together with Litera's powerful document lifecycle, security and collaboration solutions as an absolutely unbeatable combination."
AxxiTRIALS aims to improve operating efficiencies by uniting global trial teams, from Sponsor, CRO and sites, under a single interface that is easy to use, engaging and integrated with existing systems. AxxiTRIALS' customizable workflow tools and compliant document management system aims to speed the site start-up process, ensure compliance, centralize key trial information, create community and keep investigators and site coordinators engaged throughout the clinical trial.
"Pharmaceutical, medical device, biotech and clinical research organizations that leverage the power of the web see a tremendous acceleration of their trials, particularly in the areas of start-up and patient recruitment, enabling life-saving products to get to market faster," said Susan MH Lewenz, founder of AxxiTRIALS and now VP and General Manager at Litera for the AxxiTRIALS franchise. “Interestingly, the CRO clients who have private-labeled our offering tell us that it has even helped them win new business, as many trial sponsors have now witnessed this speed improvement and demand a portal be used for their projects.”
AxxiTRIALS is used for trials of all sizes in locations all around the world to accelerate document handling from feasibility and site start-up documentation, to ongoing safety alert, training and communications management, through the locking of the trial master file. Like other Litera products, AxxiTRIALS is designed to be so intuitive that it requires little or no training, works on any device anywhere in the world and provides the right content and tools for the business process.
AxxiTRIALS joins a powerful suite offered by Litera, including its Galaxy portal solution for document and matter collaboration across enterprises, as well as solutions for document templates and numbering, content assembly, document comparison, rights management, large/secure file transfer and synchronization, and metadata management.
CAHtalyst Trial Shows Crenessity Sustains Efficacy in Classic Congenital Adrenal Hyperplasia
July 14th 2025Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.