The leading Australian CRO for biotechs and Frost & Sullivan Asia-Pacific CRO Market Leadership Award winner Avance Clinical has been invited to present on the future of decentralized clinical trials at the Oracle Health Sciences Connect conference.
Title: Decentralized Trials – No Going Back
Time: 23 April, 2021 – 3.05 pm (Australia/Adelaide ACST).
Avance Clinical CEO Yvonne Lungershausen, shared the company’s insights on the future of Decentralized Clinical Trials (DCTs) and the technology and patient factors that will determine success.
Avance Clinical uses the full range of eClincial technologies to support clients wanting DCTs or a site-based approach while still leveraging advance technology including ePro, eSource and eConsent.
“DCTs are fast becoming the new norm and this is an incredible opportunity for the drug development sector as well as the diverse and remote patient populations that will now have access to clinical trials,” said Lungershausen.
“The pandemic has been the catalyst in speeding up the adoption of decentralised clinical trial methods, as people stopped participating in trials and visiting clinics. Trials have stalled putting lives and significant investments at risk.”
Yvonne Lungershausen said there are considerable benefits to DCT’s including:
- Reduce the scheduling and travel burden on patients – providing care from the comfort of the patient’s home.
- Connecting patients to trials on a global scale – patients that were otherwise inaccessible under more traditional trial protocols are now available
And she said challenges include:
- Missed human-to-human contact and continuity of patient care
- Investigational product distribution to more remote destinations
- Oversight of compliance and study procedures in the patient’s home
The presentation also covers advances in artificial intelligence (AI), machine learning, cloud computing and blood self-collection devices which are all revolutionising the decentralized clinical trial process.
- Wearable devices are demonstrating enormous potential whether worn as a wrist strap or as an adhesive patch on the body. AI-embedded capabilities allow these devices to measure a patient’s heart rate or metabolism remotely. Linked to the cloud through secure networks, clinicians can receive and analyse the data in real time.
- Video calling and electronic reminders, can improve patient compliance in trials – prompting participants to take their medication at the right time or to record in their electronic diary development.
- Technologies are developing to allow patient centric sampling (self-collection of specimens) with devices that require either the use of a lancet and a finger prick whereas others do not, making clinical trials even more convenient.
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.
Ends
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.
The leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical has expanded its eClinical solutions offering, with advanced digital clinical tools for enhanced patient engagement, visibility, data capture, and analysis. www.avancecro.com/eclinical-solutions
Avance Clinical made the announcement at BioPharm America (September 21-24, 2020)
Avance Clinical’s biotech clients now have the option to deploy the latest eClinical solutions to maximise the value of study data and deliver real-time visibility on study progress.
Avance Clinical CEO Yvonne Lungershausen said:
“Our Data Management team works with eClinical leaders such as Medrio to offer regulatory compliant and patient-centric tools for rapid start-up and continual data flow.
These tools improve patient engagement and data collection and allow Sponsors to stay informed at every step with Sponsor visible portals.”
The Avance Clinical eClinical services include the following:
eSource
- Direct data capture of source data on site
- Forms customised by Avance Clinical Data Management team
- Edit checks built into forms; instant firing of queries once data is entered
- Option for data to be collected off-line and synced when on-line is available
- Fully integrated with Medrio EDC, data visible for Sponsor review instantly
- Remote monitoring and data review on ongoing basis
- Avance Clinical provision of tablets if required
eConsent
- Electronic consent including patient sign-off and investigator confirmation
- Customisable to include animations, videos and questions as required
- Forms customised by Avance Clinical Data Management team
- Link via email to patient
- Compatible with any device and internet system (smart phones, tablet, laptop, desktop)
- Integrated with Medrio EDC
- Link can be shared with HREC as part of submission package
ePRO
- Electronic capture of patient-reported outcome, including diary data, dosing compliance, questionnaires, VAS/Pain scales
- Forms customised by Avance Clinical Data Management team
- Link via email to patient
- Options for emails and reminders at set times during the day or week
- Timezone adjusted to patient’s location
- Compatible with any device and internet system (smart phones, tablet, laptop, desktop)
- Fully integrated with Medrio EDC, data visible for Sponsor review instantly
Glynn Morrish, Avance Clinical Director Biometrics said:
“Direct electronic capture of study information and the complimentary suite of solutions offered by Avance Clinical allows the company and its clients to maximise clinical trial efficiency and flexibility while ensuring data integrity is preserved.
Our highly trained and experienced biometrics team are excited to continue to work at the forefront of innovation and technology and provide services that offer stability and robustness to studies being conducted in an ever-changing global environment.”
Avance Clinical is an Australian-owned Contract Research Organisation that has been providing high-quality clinical research services fit for global regulatory standards to the local and international drug development industry for 20 years.
The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical, joins Medrio’s new podcast series Trial Talks (listen here https://medrio.com/podcast/why-clinical-trials-are-thriving-in-australia/).
Medrio, Inc. is the leading provider of eClinical technology to pharmaceutical, biotech, medical device, diagnostics, and animal health markets. The first of the new Trial Talks podcast series features Avance Clinical CEO Yvonne Lungershausen and Director of Business Development Operations Sandrien Louwaars interviewed by Mike Novotny, CEO at Medrio.
Trial Talks is a clinical trials podcast series hosted by Medrio thought leaders. Trial Talks season one will focus on industry trends and challenges, unique solutions, and the perseverance of the industry through one of our toughest challenges, COVID-19.
Trial Talks season 1, episode 1 “Why Clinical Trials are Thriving in Australia” focuses on how Avance Clinical prepared for the pandemic, what tools were leveraged that allowed trial continuation, and why clinical trials are currently thriving in the region.
Medrio and Avance Clinical recently reached a milestone of supporting 150 clinical trials together.
Medrio and Avance Clinical’s successful partnership began in 2012 on a Phase I study with 103 patients and 14 sites, with Avance Clinical being Medrio’s first CRO partner in the Asia-Pacific.
Avance Clinical has utilized Medrio’s electronic data capture (EDC) solution successfully for the past eight years supporting 158 Phase I studies, 6,047 patients, and 236 sites. The HRECs usual review cycle in Australia, which takes only 4 to 8 weeks, coupled with Medrio’s ability to achieve FPI in less than three weeks is a perfect combination for accelerating study starts, a critical component to Phase I trials.
Yvonne Lungershausen, CEO at Avance Clinical said:
“Medrio has always been a wonderful partner to Avance Clinical. In addition to their EDC, we’ve used their ePRO and Direct Capture solutions, and we’re always impressed by not only their speed and flexibility but also their support. We know that if we have a question or need assistance that it will be addressed immediately and resolved quickly. Our partnership continues to flourish through ongoing clinical trials. We also recently had a great conversation with Medrio on their podcast, Trial Talks, about Australia’s unique position in the midst of COVID-19. I look forward to the continued success and growth of our partnership.”
Mike Novotny, CEO Medrio said:
“I’ve always been data-driven, and reaching the 150 trials milestone speaks volumes about Medrio and Avance’s relationship. Trust is earned, and I’d like to think that we’ve shown that we offer not only sophisticated clinical trial technology but also pride in our work. Our support team is available 24/7 and I am always proud to hear our customers speak so highly of them.
At Medrio we always have the patients in mind, and the faster we can get a trial up and running or provide support, the faster the patients in need will have the drugs, therapies, or devices that they need. I enjoyed interviewing Yvonne Lungershausen (CEO) and Sandrien Louwaars (Director of Business Development Operations) for the first Trial Talks podcast episode. It was fascinating to hear how Australia and New Zealand are operating in the midst of a global pandemic, and it highlights the perseverance of the industry and the Golden Age of pharma.”
About Medrio
Medrio is the leading provider of eClinical technology for pharma, device, and diagnostics clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient-reported outcome responses. Study sponsors and Contract Research Organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. For more information, please visit http://www.medrio.com.