Aotearoa Clinical Trials Becomes 1st Site In NZ To Achieve GCSA Certification & Silver Workforce Quality Accreditation

Certifications demonstrate Aotearoa Clinical Trials is
working to the highest global best-practice standards,
ratified by the industry

Auckland, New Zealand and
Maidenhead, United Kingdom, 20 February 2024 – Aotearoa
Clinical Trials (ACTT) has undergone a rigorous
evidence-based assessment process to become the first
organization in New Zealand to successfully achieve the
GCSA’s Global Quality Standard for Clinical Research
Sites. This is further bolstered as ACTT has also achieved
the Silver Workforce Quality Accreditation (WQA) from IAOCR,
the International Accrediting Organization for Clinical
Research, the first New Zealand Organization to achieve
this. These accomplishments demonstrate that ACTT is
consistently working to the highest global quality
best-practice standards for workforce and research
operational processes.

“Aotearoa Clinical Trials is
a network of hospital based clinical trial sites with over
20 years’ experience in clinical trials in Aotearoa – New
Zealand. We are proud to be the first site in Aotearoa –
New Zealand to be accredited to this international standard
of quality,” explains Dr Edward Watson, CEO, Aotearoa
Clinical Trials. “The GCSA endorsement of our processes,
systems and team are testament to the value we place on high
quality outcomes to ensure patient safety and high-quality
data and provides assurance to our partners and the Industry
that we run our clinical trials to an internationally
recognized standard.”

These two certifications were
awarded following a robust evidence-based assessment of
their site business operational processes (for GCSA) and
workforce processes (for WQA). The GCSA assessment involved
a review of business operational procedures and discussions
with staff to gain a full understanding of how ACTT works as
an organization in terms of trial delivery. The review looks
at seven key impact areas that underpin the safe, effective
delivery of clinical trials and the quality of both patient
and sponsor/CRO journeys. Combined with this, ACTT also
underwent the WQA assessment, which follows a similarly
robust process, but focuses more specifically on workforce
processes and the frameworks required for ensuring a
high-performing, engaged, committed and competent workforce
which is crucial for reducing risk and delivering high
quality clinical research.

“Our team are at the
heart of the business. We are constantly looking for
innovative ways to ensure our team are competent, confident,
and supported to provide the highest quality service to our
patients, their whanau/ family, sponsors and partners. I am
proud to be part of an entity that not only talks about
quality and standards but can tangibly demonstrate that
commitment,” comments Karen Carter, Director Clinical
Operations.

“Working with ACTT was a really positive
experience, and it was clear that the organizational values
are widely known and adhered to, forming an excellent
cultural platform to work from, and this stems from the
strength of the leadership,” comments Sarah Everitt, VP
Operations, IAOCR and GCSA. “ACTT has spent a significant
amount of time in developing a specific organizational
identity and culture driven by a passionate leadership team
and this approach is definitely paying dividends in the
organization. They really deserve these
awards.”

Both IAOCR and GCSA use comprehensive
assessment frameworks, that have been developed with and
ratified by industry experts. The GCSA quality standard for
clinical research sites was developed with the support of a
Global Advisory board of key stakeholders and experts from
across the industry. In addition to the IAOCR Investigator
Accreditation, all seven areas of the GCSA quality standard
were met which included: Governance; Site Business Strategy;
Workforce Quality; Patient Engagement; Feasibility; Study
Start-up & Initiation; and Study Management, Operations
& Close Down. WQA provides a clear benchmark of the
highest workforce standards for both those working within
the organisation to pride themselves on, as well as for
sponsor’s and CROs looking to partner with an organisation
who want to see formal evidence of the workforce standards
that are being delivered.

Whilst clinical research is
a highly-regulated industry, until now there have been no
established standards by which sites can demonstrate that
they are able to meet the expectations of sponsors, CROs and
patients, and no way for sponsors or CROs to select clinical
research sites based on clear quality standards which have
been independently assessed at the organizational level.
GCSA sets this much-needed industry standard for research
sites to strive for and achieve; It allows sites to evidence
and communicate their capabilities and differentiate in a
crowded and increasingly competitive marketplace. Beyond the
assessment and certification process, where required, GCSA
will deliver individual, practical support on the areas for
development to meet the standards and will work
collaboratively with sites to achieve
certification.

To learn more about IAOCR and GCSA how
we can support your business please visit iaocr.com and
gcsaassessed.org, or email info@iaocr.com or
info@gcsaassessed.org. Alternatively, for both organizations
you can call:

International: +44 1628 784906

US
Toll Free: +1 855 209-2335

UK: 01628
784906

© Scoop Media