Pharma and biotech companies are the backbone of the healthcare space, developing new medicines and techniques for faster and effective curing. However, the pharma industry has been restructuring its research and development activities quite recently. One of the key reasons for this is the constant pressure from government regulations, generic competition, and then the declining revenues. Though a lot of CROs are responding to these changes by constantly improving their service and helping streamline the process, the distance is long. Bridging this gap between biotech companies and the processes is Avance Clinical—a full-service CRO that leverages the entire suite of eClinical technologyto deliver clinical drug development services for international biotechs. Avance Clinical delivers customized solutions designed around specific client needs rather than a one-size fits all approach.

Avance Clinical is the largest full-service Australian CRO delivering quality clinical trials with globally accepted data in Australia and New Zealand for international biotechs. A higher portion of the company’s clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. The company offers pre-clinical services with their experienced ClinicReady team right through to Phases 1 and 2 leveraging significant Government incentive rebates of 43.5% and rapid start-up regulatory processes. “With a world-class team of more than 200 clinical experts with experience across more than 105 indications, we can deliver cutting-edge results and high-quality internationally accepted data for FDA and EMA review,” explains Yvonne Lungershausen, CEO, Avance Clinical.

As a company, Avance Clinical focus on state-of-the-art technology and systems across all functional areas to provide clients with the most effective processes. Medidata, Oracle, and Medrio are just some of the technology partners. The company is a pioneer in delivering some of the most extensive in-house clinical services including ClinicReady – pre-clinical services, clinical monitoring management, eclinical solutions, safety and pharmacovigilance, medical writing and project management.

Surrogate Drug Development Department for Start-Up Companies

Avance Clinical has a dedicated scientific and regulatory affairs service, ClinicReady, headed up by Gabriel Kremmidiotis, Chief Scientific Officer, Jorgen Mould PhD, BSc (Hons). This is in response to increased demand from biotechs for preclinical study management and scientific and regulatory advice to take their products to first-in-human trials.

The ClinicReady range of services constitutes a natural progression in Avance Clinical’s role as the premier provider of early drug development support to the biotechnology sector. The company recognizes the major challenges faced by small biotechnology companies, particularly start-up companies who seek to drive their novel therapeutics to demonstration of safety and preliminary clinical Proof of Concept.With ClinicReady, Avance Clinical’s team can act as a surrogate drug development department for start-up companies who are looking to benefit from a virtual model of operationalization and execution from the early stages of drug candidate discovery to demonstration of preliminary clinical POC.

The company’s ClinicReady Services include preparation of drug development plans (from discovery to phase II proof of Concept) to regulatory agency submission and human research ethics approval. The company also provides program gap analysis with particular emphasis on preclinical study plans, preclinical vendor selection and management, and scientific advice on translational aspects with emphasis on attaining evidence of pharmacological effect early in clinical development. Avance Clinical’s clientele can benefit from the team’s therapeutic area advice with particular emphasis on product differentiation and positioning within existing and evolving therapeutic paradigms and chemistry Manufacturing Controls (CMC) and Investigational product management Advice.

What’s more interesting is the fact that Avance clinical data is accepted by all major regulatory authorities around the globe including the FDA.The company’s data management team provides accurate and precise end-to-end data management services.“Our clinical data management team has gained anoutstanding reputation for accuracy, precision, and quality of their biostatistics and pharmacokinetic (PK) analysis. Furthermore, our highly experienced staff provides seamless in-house end-to-end clinical data management services using streamlined capture, analysis, and reporting pathways to deliver your team quality data sets,” points Lungershausen.

The Avance Clinical Advantage

Avance Clinical deploys the latest eClinical solutions including eSource, eConsent, and ePro to maximize the value of study data and deliver real-time visibility on study progress.The team works with eClinical leaders such as Medrio to offer regulatory compliant and patient-centric tools for rapid start-up and continual data flow.Avance Clinical’s eClinical solutions improve patient engagement and data collection and enable clients to stay informed at every step with ePortals.

The company delivers globally accepted data, electronic consent including patient sign-off and investigator confirmation and it is highlgy customizable to include animations, videos and questions as required. In addition, the solution is integrated with Medrio EDC, and its link can be shared with HREC as part of submission package.

Another advantage with Avance Clinical is the eConsent that enable direct data capture of source data on site. The forms can be seamlessly customized by Avance Clinical Data Management team. The solution also enables edit checks which is built into forms; instant firing of queries once data is entered and remote monitoring and data review on ongoing basis.

Avance Clinical’s ePro capability enables to seamlessly capture electronic patient-reported outcome, including diary data, dosing compliance, questionnaires, VAS/Pain scales. Its forms are customized by Avance Clinical Data Management team. Enabling a seamless operations, the clinic can link via email to patient with options for emails and reminders at set times during the day or week. The highly intuitive system is compatible with any device and internet system (smartphones, tablet, laptop, desktop) and fully integrated with Medrio EDC to enable data visiblity for sponsor review instantly.

End-to-end data management

Avance Clinical’s Statistical and Pharmacokinetics Services provide in-house end-to-end data services using streamlined capture, analysis and reporting pathways. “Our team provides a range of services related to the regulatory-compliant CDISC model, with a focus on the SDTM and ADaM standards and their supporting documentation,” explains Lungershausen.

The company’sstatistical and pharmacokinetics Services include:

• Optimized study design and protocol review, including sample size calculations
• Statistical Analysis Plan (SAP) development
• Comprehensive suite of randomization solutions
• CDASH conforming CRF design
• CDISC compliant SDTM and ADaM dataset implementation
• Conversion of legacy data for current submissions
• Complex statistical analysis
• Rapid PK analysis for interim decision making
• Tailored presentation of individual data and aggregated data
• Use of validated specialist software (WinNonlin and SAS)
• Clear and concise communication to all stakeholders
• Embedded quality assurance

Agile, and Adaptive Solution-Oriented Clinical Research Services

Since opening its doors in 1997, Avance Clinical has been a pioneer in delivering cutting-edge solutions to its huge clientele. Avance Clinical has bagged the Frost & Sullivan Asia-Pacific CRO Best Practices Award recipient for the past two years and has been providing CRO services in the region for the past two decades. Today, the Australian and Avance Clinical Advantage is all about the rapid start-up, leveraging 43.5% rebates to reduce costs, and delivering internationally accepted quality data from world-leading clinical settings, KOLs and PIs. Avance Clinical data is accepted by all the major regulatory authorities including the FDA and EMA. The company has a powerful Australian and New Zealand network of proven PIs and clinical sites. “Our biotech clients start their Phase I without having to wait for an IND, saving up to a year in regulatory timelines and considerable costs. Our clients are currently experiencing a 3-week IRB/EC turnaround due to the supportive regulatory and clinical environment, and Avance Clinical’s experience.