Biotechs get scalable early to late phase clinical offering from Avance Clinical and Cromos Pharma - announced at Bio-Europe 2020
JCN Newswire 2020年10月28日 02:04:00
BIO-Europe, Munich, Oct 28, 2020 - (JCN Newswire) - 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.
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.
About Avance Clinical, www.avancecro.com
Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations for biotechs. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. eClinical solutions capabilities - speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons
Media Contacts:
Avance Clinical
Chris Thompson: media@avancecro.com
Cromos Pharma
Nicola Donnelly: media@cromospharma.com
Copyright 2020 JCN Newswire. All rights reserved. www.jcnnewswire.com
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.
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.
About Avance Clinical, www.avancecro.com
Australia's Avance Clinical has more than 20-years of experience and is now one of Australia's leading Contract Research Organizations for biotechs. Avance Clinical is committed to providing high-quality clinical research services with its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually grows through the careful selection of experts who also demonstrate passion in their chosen field.
Avance Clinical offers high-quality services in an established clinical trial ecosystem, that includes world-class Investigators and Sites able to access specialized patient groups.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial spend
2. eClinical solutions capabilities - speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 - 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and sites
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia's counter-flu and allergy seasons
Media Contacts:
Avance Clinical
Chris Thompson: media@avancecro.com
Cromos Pharma
Nicola Donnelly: media@cromospharma.com
Copyright 2020 JCN Newswire. All rights reserved. www.jcnnewswire.com
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