17 JANUARY

Creating Solutions to Deliver Rapid & High-Quality Clinical Trials

Case study

PharmaSols experts create solutions to deliver rapid and high-quality clinical trials

At PharmaSols our ability to deliver successful clinical trials alongside our global sponsors is driven by the quality of our team of experts. Our dedicated team works collaboratively with our partners to passionately deliver rapid, high-quality clinical trial services to global biotechs.

Clinical trials are complex, each one is different, and things don’t always go to plan. The specialised skills offered by our team of experts cover an array of tasks, ranging from protocol development to final clinical study report, giving global biotechs the confidence that all aspects of their clinical trial will be managed by the best in the industry.

We have some of the best people in the industry working at PharmaSols ensuring our team comprises of the right people, with the right attitude and capabilities, drawn from an ideal combination of scientific, academic, and operational understanding.

Our global team of experts have, on average, more than 20 years’ industry experience across all phases, a wide variety of therapeutic areas, and have managed every aspect of clinical trials.

The driving force behind success is our team of experts dedicated, skilled and experienced, able to work collaboratively and flexibly to provide rapid solutions to handle all the unique and unusual challenges each clinical trial provides.

“Can do attitude, combined with experience and skills. The PharmaSols team is a team of experts, the right team of people to ensure the success of your clinical trial” - Jacquie Palmer, Managing Director

Challenges overcome by experience 

Our team have needed to respond quickly to challenges supporting different studies and the experience of our team has enabled us to create rapid solutions for our global sponsors.

• Increased patient recruitment targets
• Identification of target sites for rare/less prevalent therapeutic areas
• Rapid study start-up
• Unforeseen issues with central lab

Tackling Increased patient recruitment targets

In a recent COVID-19 vaccine study, due to the trial’s early pre-screening success and patient recruitment, the global sponsor decided suddenly to double their initial patient target. This new patient target presented a new set of challenges as the increased target participant numbers needed to be approved by the Health and Disability Ethics Committees (HDEC) within the original 28-day timeframe during a COVID-19 lockdown.

PharmaSols maintains well-established relationships with a network of organisations, including the New Zealand HDEC team and our team have a thorough understanding of the HDEC processes. This allowed us to successfully quickly apply for the necessary ethics and regulatory approvals and the recruitment process was able to continue without any disruption.

Even in the face of COVID-19 lockdowns, tight timeframes, and a sudden increase in patient recruitment targets, PharmaSols was able to deliver 204% of the initial recruitment target in only 26 days.

Leveraging regional Ethics and Regulatory knowledge and experience

Ethics applications in Australia and New Zealand require equity within different cultures and international sponsors don’t always understand how to best answer questions about the vulnerable populations and the cultural considerations in this specific region.

For a recent ophthalmology study, the protocol was designed, and the ethics application was submitted to New Zealand HDEC by the global sponsor. Upon review of this application and protocol, PharmaSols identified issues which would have resulted in the rejection on their ethics application. Necessary changes were quickly made to the protocol and application to include special cultural considerations for the Maori patients being recruited in this study.

This review and subsequent changes to the protocol design and application resulted in the sponsor obtaining ethics approval on time. The review and alterations made by our team, leveraging their regional knowledge of cultural and ethical requirements in this region, prevented delays in study start – Saving time and money for the sponsor.

Rapid start up, leveraging local relationships and regional knowledge

Achieving rapid study start-up gives sponsors a strong starting position for clinical trials. PharmaSols works efficiently to achieve tight start-up timelines – 35 days start-up (final protocol to first SIV) for a recent study, and 19 days start-up for a COVID-19 related trial.

These rapid study starts are achievable due to our existing relationships in the Australia and New Zealand region with key organisations involved in clinical trials, as well as our team of experts’ regional knowledge about the ethics and regulatory approval processes - Saving time and money for the sponsor.

Understanding the region, Identifying Multiple target sites for difficult studies

Site identification is the first and most critical deliverable from a CRO. PharmaSols has a proven ability to identify sites, even in challenging environments.

In three recent studies, our team of experts were tasked with identifying 18 sites in the region. The first was an ophthalmology study, which is typically a challenging therapeutic class to recruit sites for as they are reluctant with early phase trials. The other two studies were both oncology studies; this therapeutic area is heavily saturated and competitive; site recruitment has historically proven to be a challenge.

Across these three studies, PharmaSols achieved a rate of 117% of the global sponsor site target. Through our team of experts and our established relationship with sites, we were able to deliver above sponsors expectations.

Proven experience to deliver creative solutions for unforeseeable issues

For a study with a US Biotech, our sponsor was struck with an unforeseeable issue when a Central European laboratory processing the trial samples became the victim of a cyberattack. This prevented our sites from accessing the lab results data they needed to determine which of the participants could proceed forward in the trial.

PharmaSols’ agility once again became a defining solution for this trial. By working closely with the lab, we manually determined which participants' lab results could be prioritised each day. We provided the sites with daily updates and kept the trial on track. The experience and flexibility to deliver under pressure.

Advantage of scalability

Small and medium sized biotechs are often built on a strong foundation of research and struggle with the first steps of commercialisation. A CRO provides broad expertise to global biotechs, an extension of their own teams’ skills and knowledge, working with them hand in hand to deliver clinical trials and expediate commercialisation.

PharmaSols provides global sponsors with cost effective depth of experience from our team of experts in every area of clinical trials, allowing biotechs access to the right experienced resource, when needed.  PharmaSols can be as large or as small as each project requires immediately responding to trial needs, ensuring quality and the right level of experience.

In a recent COVID -19 vaccine trial suddenly increasing patient recruitment numbers meant that PharmSols needed to quickly respond with additional monitoring and CRA resources. PharmaSols was able to immediately provide co-monitoring at site, providing the experts needed to cope with increased monitoring without any delays.

With over 20 years of experience in this region, PharmaSols has an established and trusted network of experts and a proven creative approach to problem-solving. To ensure your clinical trials success. Get in touch with us to see how we can help support your trial.