Saturday, 24 October 2020


New Webinar Alert : How 'ClinicReady' by Avance Clinical Gets Biotechs into Clinic Faster

23 September 2020 | News

Sponsored By Avance Clinical

 

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How 'ClinicReady' by Avance Clinical Gets Biotechs into Clinic Faster

In this webinar you will hear from the leading Australian CRO for biotechs, and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner, Avance Clinical about ClinicReady a dedicated scientific and regulatory advice service that gets biotechs into clinic faster.

The highly regarded Avance Clinical scientific and regulatory team has been advising biotech clients on their drug development for more than 20 years and is now the dedicated ClinicReady service under the Avance Clinical banner.

Why Biotechs Need ClinicReady
"With our two decades of CRO experience we have become acutely aware of the importance of advising clients earlier in the development process, prior to them commencing preclinical safety and toxicology activities, so they conduct an appropriately balanced set of preclinical studies to get the right data for approval of their first-in-human study in Australia," said Dr Gabriel Kremmidiotis, Avance Clinical's Chief Scientific Officer.

The ClinicReady team has also expanded with the appointment of Dr Jorgen Mould as Scientific Affairs Specialist.

"Dr Mould has over 20 years of experience in the medical industry specialising in drug discovery and clinical development. He was appointed to further expand our range of services to cater for the preclinical research management needs of small biotechnology enterprises and assist them in bringing their products to clinic," said Yvonne Lungershausen, Avance Clinical’s CEO.

"Having spent several years taking biotech products to the clinic, I am really looking forward to the opportunity of sharing my experience with Avance Clinical’s clients in a way that expedites access to the clinical trial testing for their preclinical assets," said Dr Mould.

ClinicReady has been formed in response to increased demand from biotechs for dedicated expertise in preclinical study management and scientific and regulatory advice to take their products to first-in-human trials.

The ClinicReady team of scientific and medical affairs specialists comprises PhD qualified individuals with decades of experience in industry and academic research. They provide clients with scientific, regulatory and medical writing services, preparation of investigator brochures, clinical trial designs and study protocols, and patient information and consent forms as well as clinical trial data and clinical study reports.

ClinicReady by Avance Clinical offers the following services:

  • Gap Analysis
  • Preparation of Drug Development Plans
  • Pre-clinical vendor selection & management
  • Scientific Advice
  • Therapeutic Area Advice
  • Chemistry Manufacturing Controls (CMC) Advice
  • Preparation of Investigator Brochure
  • Regulatory agency submission support

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.

Speakers



Jorgen Mould PhD,
BSc (Hons) Avance Clinical's Scientific Affairs Specialist



Gabriel Kremmidiotis, PhD, BSC Hon
Chief Scientific Officer

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