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.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.