SAPRO Scoop - Ed 01, 04-Feb-2025
Hello there,
Welcome to the inaugural edition of the SAPRO Scoop Monthly Newsletter!
Here’s what we’ve been up to and what’s coming next.
1. Company Highlights
Celebrating Milestones:
This month, we enrolled our 250th participant in a SAPRO clinical trial.
Congratulations to the team for their dedication over the years, to our clients for placing their trust in us and our alliance partners, sites and most importantly trial participants for their involvement in driving clinical trial success.
Team Member Spotlight:
Congratulations to our Clinical Trial Associate Laine Gourley for completing her Virtual CRA Simulation training and assessment by an expert assessor and advisor.
The course has objective grading and comprehensive metrics, which ensures even our most senior CRAs are continually qualified for their role given the crucial impact that quality monitoring has on clinical trial delivery.
We value the professional development of our team and don’t follow the typical titles of roles; we believe in the substance of what an associate can bring to our teams and how they too are fulfilled within their own roles.
Want to learn more about this CRA training program? Get in touch at [email protected]
New Product Launch:
We’re excited to announce the launch of SafeSPHERE, our new, fully validated pharmacovigilance database solution.
SafeSPHERE will be available for all studies starting in March 2025 and is fully compliant with FDA 21 CFR Part 11 and EMA Annex 11 requirements.
The implementation of SafeSPHERE will increase consistency across various programs for our clients where the system can grow with them across many phases, this will ensure timely, clear and concise reporting and reduce any anxiety around regulatory requirements and reporting requirements.
This is another initiative that further emphasizes our commitment to cost-effective, fast and quality clinical research oversight for our clients whilst accessing the gold standard at all times.
2. Latest Industry Trends
ICH GCP E6(R3):
The latest update to ICH GCP E6(R3) transforms clinical trial practices by prioritizing efficiency, patient safety, and technology integration.
Here’s what you need to know:
Take-home message: GCP E6(R3) is not just about compliance—it’s about empowering sponsors and optimizing trial efficiency while keeping the patient at the heart of every decision. The future of clinical trials is here, and it’s more dynamic and patient-focused than ever!
The SAPRO team have all undergone ICH GCP E6(R3) training in advance of Step 5 per the recommendation of the consortium.
In 2024 the Trend Continued:
According to ANZCTR data, 2024 saw a continuation of the trends observed since 2018 in a slight reduction in the number of newly registered commercially-sponsored, and non-commercially sponsored clinical trials in both Australia and New Zealand.
Between 2018 and 2024, the Total Number of Clinical Trials has reduced from 2367 to 1992 (19% reduction). Commercially-sponsored clinical trials reduced from 385 to 275 (29% reduction).
See chart below.
Note this is not active trials in a given year, but rather new trials registered in ANZCTR or ClinicalTrials.gov in a calendar year.
The contributing factors to the slight retraction in the number newly registered commercially-sponsored clinical trials have not been investigated. Some plausible contributors could be:
? A trend towards increasing complexity of trials over time
? Increasing competition with other regions for clinical trials
? Trend towards fewer countries and/or sites per trial
? Reduction in new trials globally
What do you think the factors are? Get in touch: [email protected] or be a part of the conversation on our LinkedIn page.
领英推荐
New Year, New Opportunities:
In Jan-2025 alone, 126 unique clinical trials were registered with ANZCTR and/or ClinicalTrials.gov for Australia and New Zealand. Of these 32 (25%) were commercially sponsored trials.
These are comparable numbers to the numbers of trials registered in the first month of the year since 2020, with exception of the post-COVID peak in 2022.
Sponsor location of these new commercially-sponsored trials shows a high representation of USA (50%) and ANZ (30%) -based sponsors, with a few sponsors located in Europe (16%) and one in China (3%).
3. Opinion: Why Clinical Research?
If you polled a random sample of people working in clinical research and asked them how they got into the industry, chances are the most comment response would be “I just fell into it" or “I slid in sideways”.
Regardless, of how we get here, the vast majority of people stay and have long and valuable and rewarding careers.
Why?
Chances are that once an intervention (drug, device or combination) arrives at clinical trial testing stage, it has been supported by an incredible amount of blue skies research, and formal R&D, not to mention vast quantities of money, blood (literally) sweat and tears as well.
As such, a clinical trial distils the past and future into the present activities and sits at the nexus of:
All of this means that Clinical Research is a critical human endeavor:
How do we bring the promise of a new health technology into the future with todays efforts?
The success of any clinical trial is dependent upon the collective experience of all participants in the value chain and it is critical that all parties recognize this and work as efficiently as possible to ensure that the best therapies are developed in cost-effective manner.
At SAPRO we recognize this burden and it has informed our Company philosophy. As “Your Trial Pathway Partnership”, our goal is to enable more efficient research by providing services that are:
From our Patients/Patient Groups to our Clients and all in between including Couriers, laboratories, Sites, recruitment agencies, thank you for the work that you do and the part that you play in driving the future of medicine and human health.
4. What’s Coming Up
Conference Attendance:
SAPRO will be attending Life Sciences Summit in Wellington, New Zealand between 17-19 Mar 2025.
Attending? Get in touch with SAPRO Strategic Partnerships Director Charles Beasley to arrange an in person meeting – [email protected]
o Website: https://lifesciencessummit.co.nz/register/
SAPRO Webinar:
We will be hosting our first Webinar, which will provide an opportunity to meet the SAPRO team and learn about our plans for 2025. Mark it in your calendars. And invitation will be released closer to the time.
o Date: Tues 25-Mar-2025, 10 am AEDT
o Link: will be shared closer to the date.
5. We Want to Hear from You!
What topics would you like to see in future newsletters?
Get in touch with us [email protected]
Thank you for being a part of our community.
Stay connected with us on LinkedIn or reach out anytime via email.
SAPRO – Your Trial Pathway Partner
Copyright (C) 2025 SAPRO Consulting Pty Ltd. All rights reserved.
Head of Clinical Research at Douglas Pharmaceuticals
3 天前First edition looks great - well done team
Discipline Lead/Programme Coordinator (Medical Imaging) at Tepukenga/ Unitec Institute of Technology
3 周Looks great