Editor

The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical has further enhanced its innovative clinical research technology solutions with the addition of Oracle Argus.

The implementation of Oracle Argus pharmacovigilance system is the latest addition to Avance Clinical’s state-of-the-art systems suite, supporting clinical trial management services.

Safety management and reporting is one of the most important aspects of early clinical development, an area of deep strength and expertise for Avance Clinical.

The addition of Oracle Argus complements the experience of Avance Clinical’s dedicated Safety & Pharmacovigilance team headed by Pilar Garzon who has over 12 years’ experience in clinical trial safety management.

“I am very excited to have Oracle Argus as our premier safety system at Avance. I have worked with this platform for several years and consider it to be the best tool in the field,” Pilar commented.

“Oracle Argus further enhances Avance Clinical’s safety management processes within a validated built-for-purpose framework providing automation and efficiency improvements to our existing workflow throughout at all stages of safety processing and reporting,” said Gabriel Kremmidiotis, Avance Clinical’s Chief Scientific Officer.

The Argus system is of particular importance for Phase II clinical trials involving patient populations where the observation of adverse events is more prevalent compared to Phase I healthy volunteer trials. Avance Clinical is increasingly in demand for Phase II studies so the Argus platform is an important addition the technology solutions offering.

“We are excited to welcome Avance Clinical to our global community of Argus customers,” said Bruce Palsulich, Vice President, Safety Product Strategy, Oracle Health Sciences. “Argus provides proven compliance with continuously changing worldwide regulations, and its built-in automations, integrations, and usability significantly reduce manual work and maximize efficiency.  We are pleased that Avance Clinical has chosen to standardize on Argus for safety case management.”

Argus Cloud, the industry’s best-in-class platform for safety and pharmacovigilance regulatory compliance, offers a scalable and secure solution within a multi-tenant ICH E2B R3 XML compliant database for our clients.

As clinical research becomes more complex and spans regions with diverse regulatory requirements, it is vital to have a technology solution like Argus that can accommodate full safety and regulatory compliance on a single platform.

Dublin/Ireland – Adelaide/Australia – Two dominant regional contract research organizations (CRO), Avance Clinical and Cromos Pharma, with operations in Australia and Central/Eastern Europe, respectively, are successfully collaborating on a scalable clinical solution for biotechs.

The collaboration allows biotechs to quickly start their pre-IND early phase studies in Australia, then expand to Central/Eastern Europe to access the large patient populations for their Phase 2 and 3 studies.

Importantly, the AU/EU model allows biotechs to keep their data and trial management in Australia, and take advantage of the Australian cash rebate of up to 43.5% on clinical trial costs, throughout all study phases, across both regions.

“We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical. “Our eClinical and early phase expertise is well augmented by Cromos Pharma’s track record in late stage trials and rapid enrollment capabilities,” she continued.

“We have been collaborating with Avance Clinical and referring clients to each other for years,” remarked Vlad Bogin, CEO of Cromos Pharma. “But it was a true Eureka moment when we realized that combining Australia’s 43.5% tax rebate with Central/Eastern Europe’s unbeatable recruitment rates is a paradigm shift in how clinical trials should be conducted,” he concluded.

Cromos Pharma can access hundreds of millions of patients via more than 2,500 sites in Central/Eastern Europe.

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About Cromos Pharma www.cromospharma.com

Cromos Pharma provides tailored and effective clinical trial solutions to support the development of drugs that transform healthcare. An international CRO with over 15 years’ experience, we offer fully integrated services performing all aspects of clinical trials in all clinical phases and in a wide range of therapeutic areas. Cromos Pharma delivers rapid recruitment and excellent patient retention as well as expert study design and management. Cromos Pharma has strong regional experience in Central and Eastern Europe with global coverage provided by its US bases in Portland, Oregon and Miami, Florida. Cromos Pharma’s European HQ is in Dublin, Ireland. At Cromos Pharma, we know how important your product is. When the stakes are this high, you need a high-performance partner.

Key benefits:

• International expertise combined with in-depth regional knowledge in Central and Eastern Europe (300+ clinical trials conducted in 70+ indications).
• Extensive PI/site and patient network (40,000+ patients enrolled from nearly 2,500 trial sites).
• Unparalleled patient recruitment – our team met or shortened project timelines in 95% of conducted trials.
• Responsible recruitment is supported by Cromos Pharma’s “No Patients-No Payments” initiative – a unique risk-sharing program.
• Extremely short startup timelines (e.g. Georgia where we assure a study launch in less than 2 months).
• Expertise in innovative, generics and biosimilar global studies (NDAs, ANDAs, BLAs, 505b2).
• Regulatory inspections and audits that attest to the highest quality of data: EMA in 2019 (1-week oncology site inspection); FDA in 2017 (2-week oncology site inspection).
• Clinical Development Strategy – we provide expert guidance on study design, favorable venues, local and global landscape to improve study outcomes.