Avance Clinical Strengthens Trial Integrity with ValGenesis

SANTA CLARA, Calif.--(BUSINESS WIRE)--ValGenesis, a market leader in digital validation and process lifecycle solutions, announced that Avance Clinical, a leading global contract research organization (CRO) headquartered in Australia, has adopted its platform to digitally transform computer system validation (CSV) processes in alignment with Pharma 4.0 principles. The initiative will enhance efficiency, compliance, and transparency across the company’s global clinical trial operations while leveraging Australia's expedited ethics approvals and R&D incentives.

Avance Clinical proactively addressed the challenges of managing concurrent clinical trials for diverse sponsors by implementing the purpose-built digital platform, which optimizes the entire CSV lifecycle—from initial planning and detailed requirements management to rigorous testing, risk assessment, and final reporting—supporting the company’s commitment to ensuring the highest levels of efficiency and data integrity in its clinical trial operations.

“Implementing ValGenesis as our validation management system at Avance Clinical will transform our operations by ensuring data integrity, regulatory compliance, and operational efficiency. We are utilizing ValGenesis to ensure that the system validation requirements are met and the process remains efficient,” said Priyanka Chamoli, Vice President of Quality Assurance at Avance Clinical. “ValGenesis provides visibility to department heads to make decisions. This platform has standardized and automated the entire validation lifecycle, significantly reducing errors and project management efforts while accelerating system deployment. ValGenesis has enabled Avance Clinical to further strengthen stakeholder confidence and regulatory trust, positioning our organization at the forefront of quality and innovation in clinical research.”

ValGenesis offers several key advantages for CROs. It strengthens compliance with FDA and EMA guidelines, centralizes data to improve traceability and audit readiness, and accelerates drug development timelines through lifecycle automation. Standardized validation processes reduce errors, while real-time visibility and collaboration improve project oversight. The platform also enables a risk-based approach and integrates seamlessly with other vital clinical trial systems, creating a cohesive digital ecosystem that supports scalable operations and safeguards sensitive patient data.

“Avance Clinical's adoption of ValGenesis highlights the growing trend among CROs to embrace digital validation to remain competitive and deliver superior services in the Pharma 4.0 landscape,” said Steve Reynolds, chief revenue officer at ValGenesis. “Avance Clinical is not only optimizing its internal processes but also providing its pharmaceutical sponsors with the assurance of robust, compliant, and efficient clinical trial execution.”

ABOUT AVANCE CLINICAL

Avance Clinical is a full-service Contract Research Organization (CRO) headquartered in Australia, with extensive operations across New Zealand, Asia, North America, and Europe.

As the market leaders in early-phase clinical trials, the company leverages the unique advantages of the Australian market, including rapid ethics approval, no IND requirement, and the 43.5% R&D tax rebate, to provide biotechs with an accelerated pathway to clinical success. The company guides biotechs from early pre-clinical development through to late-phase studies, delivering fast results backed by robust, globally accepted data.

With expertise spanning over 250 indications across all therapeutic areas, over the last three decades, Avance Clinical has consistently delivered data recognized by key global regulators, including the TGA, FDA, EMA, MHRA, MFDS, and PDMA. For more information, visit www.avancecro.com.

ABOUT VALGENESIS

ValGenesis is the creator of ValGenesis Smart GxP, the life sciences industry’s first fully integrated, cloud-based, AI-enabled platform for end-to-end product lifecycle digitalization. Trusted by 30 of the world’s top 50 life sciences companies, our platform unifies intelligent, risk-based validation and process automation in a connected ecosystem—streamlining operations, driving compliance, and reducing risk. Purpose-built for life sciences, ValGenesis empowers global organizations to improve quality of life by accelerating the delivery of consistent, safer products. For more information, visit www.valgenesis.com