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ClinicReady Case Study

Our agile approach to drug development challenges

“The Avance team demonstrated flexibility and a solution-oriented attitude in working with us towards obtaining rapid ethics approval, thereby facilitating trial initiation in a timely and efficient manner.”

Dr. Russell Rother, President and Chief Operating OfficerTetherex Pharmaceuticals

The Client

Tetherex Pharmaceuticals: An example of using an agile approach in study design to achieve the best outcome for clients.

The Study

Tetherex Pharmaceuticals is developing a single-cycle adenoviral vector vaccine for the treatment of COVID-19. The treatment is designed for intranasal delivery which is expected to provide a more efficient front-line defense against COVID-19 in airway tissues, the site of virus entry into the body. The vaccine is currently undergoing safety testing in healthy volunteers.

The Challenge

Tetherex developed a protocol which included both intranasal and intramuscular administration of the vaccine. Since adenovirus vectors are considered genetically modified organisms (GMOs), the vaccine required a special license from the Office of Gene Technology Regulator (OGTR). This license provides a set of guidelines to minimize accidental release of the virus into the environment. Through interactions with the OGTR, it was determined that adenovirus-based vaccines administered via the intramuscular route require a Dealings not Involving an Intentional Release (DNIR) license through OGTR while vaccines administered via the intranasal route require a Dealings Involving Intentional Release (DIR) license. Obtaining a DNIR license requires 90 days while a DIR license can take up to 150 days. The timing of the DIR license created a significant delay in starting a trial which is seeking to accrue participants against the background of approved vaccine rollout in Australia. A strategy needed to be devised to allow for earlier start-up for this study.

The Solution

The Avance ClinicReady team was able to work with the client in amending the protocol design to only include intramuscular administration in the first instance following granting of the DNIR licence which allowed for earlier HREC approval and study start-up. The protocol was subsequently amended to include the intranasal administration and approval of the DIR licence shortly followed. This adaptable, staggered approach offered by ClinicReady allowed this study to rapidly proceed into the clinic.

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ClinicReady First Pass Approval Record

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More benefits

Avance Clinical can leverage all the benefits of Australia and New Zealand’s clinical ecosystem to deliver your study

Almost half clinical costs

The Government R&D grant means up to 43.5% rebate on clinical trial spend

Rapid Start-up

Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks

Start-up time

Site Initiation Visit (SIV) and Study Start can be achieved in 5 – 6 weeks


No IND required for clinical trials

GMP material

Full GMP material is not mandated for Phase I clinical trials

Gene-therapy accreditation

Avance Clinical is an accredited gene-therapy CRO

Seasonal studies

Northern hemisphere Sponsors can conduct their studies year-round by taking advantage of Australia and New Zealand's counter-flu and allergy seasons

FDA and global regulatory data compliance

Major hospitals with world-class infrastructures and dedicated Clinical Trial Units with a long track record in FDA compliant research

“Avance Clinical’s clients are international biotech companies primarily from the United States, United Kingdom, Japan, China, South Korea, Taiwan, France, and Germany. These clients are seeking a premium CRO with the same experience and advanced technology platforms offered by the major global CROs, but with an agile and customer focused approach to clinical management in Australia and New Zealand.”

Supriya Lala KunduBest Practices Research Analyst, Frost & Sullivan

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