Founded in 2014 by three highly experienced former AstraZeneca scientists, Aptus Clinical is a specialist clinical CRO with particular expertise in the design and execution of early phase trials in oncology, advanced cell and gene therapies and rare diseases.
Our decades of practical experience in working to the highest industry standards mean that we bring a deep understanding of the range of challenges every clinical trial brings. We work alongside our clients as an integrated part of the team to help reduce risk and accelerate the process of bringing new therapies to market.
Our flexible approach is tailored to meet the diverse needs of our clients, ranging from large pharma and biotech to academic centres and venture capital backed start-up companies. We are continually expanding our global footprint to offer our services worldwide.
Led by experts: our leadership team drives the business forward and plays a hands-on role with the team supporting the design, implementations and expert delivery of our client’s phase I and II clinical trials
Clinical development consultancy: our clinical development specialists offer expert consultancy in protocol design, site location and regulatory strategy of often complex and innovative trials. Our adaptive designs ensure flexibility is built in from the outset, helping maximise the value of our clients’ assets and providing expert input when needed
Clinical Services team: our highly experienced clinical operations and data management teams oversee the operational delivery of clinical trials. Through effective project management we offer our clients a bespoke service to meet specific trial needs, focusing on ensuring patient safety and high-quality data
World Leading Networks
As we are headquartered at Alderley Park, near Manchester, UK, our clients benefit from the world-leading scientific infrastructure and research and development knowledge that is renowned internationally. This long-established base supports scientific collaboration on a global scale.
Our long-standing collaboration with world-leading centres of excellence provides ready access to the large patient populations needed for specialist drug development. Of particular note in the UK are:
We are proud to be one of just nine commercial partners in the prestigious Innovate Manchester Advanced Therapy Centre Hub (iMATCH), a consortium that focuses on improving patient access to safe and effective advanced therapies. Members include The Christie, Manchester University and Manchester University NHS Foundation Trust
We are the only clinical CRO member of the UK’s Advanced Therapy Treatment Centre (ATTC) network that works to accelerate take up of advanced patient therapies
We are a supplier to the UK Government’s Cell and Gene Therapy Catapult independent centre of excellence, established to scale up cell and gene therapies by bridging the gap between scientific research and product commercialisation
Proprietary Compliance Processes
Our purpose built GCP E6 R2-compliant quality management system (QMS) is supported by an interactive roadmap and flexible documentation toolkit for maximum efficiency and risk mitigation. All of our systems and policies are regularly reviewed to ensure compliance with Data Protection Act 2018 and the principles of General Data Protection Regulations are incorporated within our governance framework and our contractual and due diligence measures.
Our audit programme is fully integrated, offering oversight of internal systems and processes and delivering ongoing compliance with all regulatory requirements. Comprehensive project audits identify potential risks at the outset, and our proactive and continuous planning measures ensure future risks are prepared for. These processes, developed through decades of practical experience, ensure smooth operational management throughout the entire drug development process.