News

How To Prevent Clinical Drug Trial Delays

Delayed clinical drug trials are a thorn in the side of any study stakeholder. This blog will discuss at the main causes of delayed trials, and what precautions can be taken to ensure timelines can be adhered to.

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How Does Rapid Start Up Affect Clinical Trials?

Fast, efficiently run trials benefit from gaining a competitive edge, a good reputation and credibility amongst stakeholders, as well as a period of exclusivity if the product is the first to be introduced to market.

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Ethnicity And Clinical Trials - Where Is the Diversity?

One of the most important aspects of a clinical trial is that it represents a diverse ethnic profile. For a pharmaceutical product to be accepted by international regulatory bodies such as the FDA and the EMA, it is essential that the patient recruitment process places ethnic diversity as a priority.

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The Impact Your CRO Choice Has on The Quality of Your Trial

Quality is paramount in clinical trials, as it ensures that the data collected is reliable and that the trial results are meaningful. However, achieving quality can be challenging, given the many factors that can impact the success of a trial.

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How to Execute a Cost-effective and Efficient Clinical Trial

Clinical trials play an indispensable role in the life sciences sector, serving as the cornerstone for determining the safety and efficacy of new medical interventions. The stakes are high; inefficient management can lead to considerable delays and increased costs. According to industry research, 45% of trials finish behind schedule.

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The Benefits of Rapid Start Up and How to Achieve It

Time is often always a factor in the development of new therapies, especially for conditions with unmet medical needs or during global health emergencies like we saw with the pandemic.

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PharmaSols CRO Dedicated Study Start-Up Team – Taking Trial Sites From Selection to Initiation Faster

Meet Jorrit Sipkema – Director Study Start-up at PharmaSols CRO, a HiRO company. Jorrit has worked over 20 years in clinical research in AsiaPac and Europe for Pharmaceutical companies, CRO's and Central Laboratories. His experience includes clinical operations, project management and quality assurance both at management and operations levels.

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Clinical Trials in ANZ: Harnessing Population Diversity for Recruitment

Recruitment and retention of trial participants can often be a critical bottleneck in clinical research. It is widely accepted that almost half of all delays in clinical trials are a result of problems with patient recruitment and retention. When it comes to the success of clinical trials, patient recruitment and retention plays a pivotal role.

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Accelerating FDA Approvals – It’s Faster Outside the US

Although it may seem counterintuitive, obtaining FDA approval is often expedited when the clinical trials are conducted outside the US. This process acceleration isn't about bypassing thorough checks or compromising on quality. Instead, it leverages the benefits of certain regions' clinical research ecosystems, like those of Australia and New Zealand (ANZ).

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Advanced Therapeutics in Australia

Australia is a recognised internationally as a Go-To- Destination for clinical research and the conduct of global clinical trials.

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Accelerating Clinical Trials: Australia and New Zealand's Streamlined Processes Attract Biotechs Worldwide

By leveraging the fast approval timelines and utilizing local contract research organizations (CROs), sponsors can achieve rapid study start-up and obtain high-quality data accepted by major regulatory bodies, ultimately saving time and costs associated with clinical trials.

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Innovative Strategies For Successful Drug Development

We are living in an extraordinary time of scientific innovation, where our understanding of biology is exploding and our ability to improve human health is unprecedented with new opportunities to develop new innovative medicines and devices.

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ANZ Region Rescues Stalled Global Clinical Trials

Randomized, controlled trials are considered the gold standard for evaluating the safety and efficacy of potential new medicines and therapies, as they provide a rigorous and unbiased way to compare treatments to placebo or standard care.

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Global Pharma can accelerate commercial sales and registration in China through Real World Data

Hainan Boao Lecheng special zone is the first area in China where RWD can be widely used. The Lecheng Real World Study (RWS) pathway allows overseas drugs, medical devices, and IVDs with clinical urgency status, that have not been approved by the China NMPA, to be sold and used in real world clinical settings in the Hainan province, China.

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ANZ – Cost-Effective solutions for clinical trials

Australia and New Zealand have risen to be the go-to region to conduct clinical trials for global sponsors due to rapid study start-up timelines, high-quality data generation, proven participant recruitment and retention, and cost-effectiveness.

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PharmaSols’ Global Team of Clinical Trial Experts

Clinical trials are complex and expensive, and the ability to keep a trial on track saves money, time, and resources for the sponsor. Each trial is unique, and things don’t always go to plan. CROs must have the expertise to manage any situation that arises.

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Save R&D Time and Cost - Webinars

Watch the sessions from the recent Harvest Integrated Research Organisation (HiRO) event in Taipei. Hear what our partners said about how the Australian region can be leveraged to deliver rapid, cost-effective, quality clinical trial solutions. Specialists from our partners speak: 360biolabs, a BioAgilytix company, Nucleus Network and Acclime Australia.

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The Go-to region for clinical trials

The ANZ region has become the go-to region for biotechs to conduct their clinical trials. That’s not surprising as the region generates high-quality clinical data while being time and cost-effective.

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HiRO – our global advantage, tailored solutions and key partnerships

Last year we announced that PharmaSols was acquired by global CRO, Harvest Integrated Research Organisation (HiRO) – recently announced as the Top CRO in the APAC region. Through HiRO, we were able to offer a larger global network, stronger leadership and investment in market-leading integrated systems and processes.

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HiRO – an emerging full-service global CRO

Last year we announced that PharmaSols was acquired by global CRO, Harvest Integrated Research Organisation (HiRO). This meant we were able to offer a larger global network, stronger leadership and investment in market-leading integrated systems and processes. This month we will discuss a bit more about our parent company HiRO – their values, vision, service offerings, partnerships, and end-to-end specialised clinical trial solutions.

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HiRO – Top CRO in APAC 2022

The world is witnessing an enormous demand for innovative medicines to manage and cure diseases. Despite the explosive record demand levels and best efforts of pharma companies during the COVID-19 pandemic, there is still uncertainty regarding the fastest approval process defined by the FDA.

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ANZ Trends Upwards in Popularity for Clinical Trials

Australia and New Zealand are considered the go-to place to conduct clinical trials for an increasing number of global sponsors. That’s not surprising as the region generates high-quality clinical data while being time- and cost-effective.

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ANZ – Destination to speed up your clinical trial

Before recruiting patients for a clinical trial, the study goes through a study start-up phase which includes processes like ethics and regulatory approval & site identification/onboarding. Ethics and regulatory processes are seen as a key limiting factor in the study start-up phase of a clinical trial.

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Australia and New Zealand – the haven for Patient Recruitment and Retention in Clinical Trials

Patient recruitment and retention are critical for the success of any clinical trial. It is widely accepted that almost half of all delays in clinical trials are a result of problems with patient recruitment and retention.

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Quality, Speed and Cost – Where can clinical trials deliver all three?

Australia and New Zealand are considered as the go-to place to conduct clinical trials for an increasing number of global sponsors. That’s not surprising as the region generates high quality clinical data while being time- and cost-effective.

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How biotechs are using streamlined Ethics and Regulatory processes in ANZ to accelerate clinical trials

We’ve always heard about the saying, time is money. You might wonder how this applies to clinical trials.

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How Biotechs can utilise Australia and New Zealand to extend seasonal clinical trials and rescue studies

Randomised, controlled trials are considered the gold standard in assessing the safety and effectiveness of potential new medicines and therapies.

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The Effect of the Pandemic on locations for conducting clinical trials for Biotechs

Through the spring of 2020, it became evident that the Covid-19 pandemic would have a dual impact on the clinical research sector. While it has provided the opportunity to conduct research for vaccines, treatments, and diagnostic tests for COVID-19; it has also acted as a major disruptive force, halting trials in their tracks, and exacerbating existing fragilities within the sector.

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Global Clinical Trials take advantage of significant Australian R&D tax incentives

Australia and New Zealand are well-established regions for international clinical trials.  Global sponsors understand the region’s ability to deliver quality research outcomes; rapid start-up, recruitment and participant retention, streamlined ethics and regulatory pathways, internationally accepted quality data from world-leading research facilities and Investigators. 

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PharmaSols’ Global Solution

PharmaSols is the oldest and best-connected privately-owned Clinical Research Organisation in the Pacific region. Having successfully supported patient needs and delivered outstanding clinical trial results for more than 20 years, our addition to the global group HiRO in November 2021 means we now provide flexible end-to-end integrated solutions to sponsors around the globe.

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Directly attributing our success to the quality of our team

Having grown to be one of the leading CROs in Australia and New Zealand, we directly attribute our success to the quality of our team.

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PharmaSols - HiRO announcement

PharmaSols acquired by the newly established global CRO based in Shanghai, HiRO.

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The ANZ Advantage

4 reasons why biotechs need to reconsider running clinical trials in the US – the ANZ advantage

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PharmaSols proud to be the NZ CRO partner on an important COVID-19 clinical trial.

PharmaSols proud to be working with Orbis Diagnostics as the NZ CRO partner on this important COVID-19 clinical trial.

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ANZ Region – place to extend seasonal clinical trials and rescue studies

The timelines for clinical trials are often disrupted or face challenges that risk their success for various reasons. However, some types of trials rely on seasons, meaning they are racing to meet nature’s own timeline. So, what happens to a study if it doesn’t meet the deadline?

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PharmaSols Partnering with Molecular Templates, Inc.

PharmaSols is delighted to be partnering with Molecular Templates, Inc. (MTEM) on their phase 1b study of MT-5111 in advanced human epidermal growth factor receptor 2 (HER2)-expressing solid tumours across multiple sites in Australia and New Zealand.

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How To Avoid Costly Errors in Ethics and Regulatory Submissions

Ethics and Regulatory applications are a necessary complexity that can determine trial start-up timeframes or, in some cases, throw trial startup timelines immediately off-target if done incorrectly. Selecting who should be responsible for completing this application can also have a significant impact on the continuity of the trial.

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Assured Continuity

Yesterday New Zealand was dealt a new challenge with one suspected case of the new Delta variant in the community. With the New Zealand government’s commitment to eradication of COVID-19 in the community, New Zealand has been placed in a lockdown for to a 7 day period. However we have proven our ability to work through the challenges of running a clinical trial through a pandemic.

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RADIO NEW ZEALAND NATIONAL_Valneva New Study

Exciting for PharmaSols CRO and NZ to be involved in this international COVID-19 vaccine trial.

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What to Look for in a CRO Partner

There are many factors that can lead to the derailment of a clinical trial. Your Clinical Research Organisation (CRO) partner shouldn’t be one of them. Understanding the importance of different regional benefits, individual organisations' responses to the pandemic, and their size can help this critical decision.

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#NewTrialAnnouncement

PharmaSols is delighted to be working with UNITY Biotechnology, Inc. (UNITY) on their latest ophthalmologic study UBX1325-02, across multiple sites in Australia and New Zealand.

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The Key to Increasing Patient Retention in Clinical Trials

There are a lot of reasons a trial can be derailed, with poor patient retention being among one of the biggest struggles. It is natural for some patients to drop out, as study participation is voluntary. However, identifying the common reasons for participant drop out helps sponsors to address these issues to increase the patient retention rate.

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We are Finalists for the Amcham-DHL-Express 'Success and Innovation Awards Exporter of the Year to the USA' $1million to $10million!

The American Chamber of Commerce in New Zealand is pleased to announce the finalists for the 2021 AmCham-DHL Express Success and Innovation Awards, the 21st year of these awards celebrating success and innovation for companies doing business with the USA.

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OUTSOURCING-PHARMA.COM _ Australia & New Zealand Appealing to Clinical Researchers: Greenphire

Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.

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Misconceptions About Running Clinical Trials Outside the U.S.

Deciding where and who will manage your clinical trial will have a direct impact on its success. This is an important, complex decision, and many factors must be considered.

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Welcome to PharmaSols

Check our video - after months of hard work and planning, we are thrilled to announce our new brand and our new website!

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The Cost of Delaying A Trial

From discovery and development through to market, the life cycle of new medicine is a profoundly complex process, frequently met with obstacles. Research produced by PhRMA found that clinical trials take on average six to seven years to assess safety and efficiency, with the overall probability of success less than 12%.

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Quality Assurance: The Key to Every Successful Clinical Trial

Quality is an essential element that underpins every aspect of a clinical trial. As an industry, we easily understand the benefits of quality monitoring to ensure quality data and clinical trial management. However, we often underestimate or do not understand the broader Quality Assurance (QA) function and how a well-trained team of QA auditors can ensure successful trial outcomes.

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How to Run A Trial During a Pandemic

When the pandemic hit, it was like someone stuck a stick through the wheels of a bike, and we all went toppling over. Everyone had the intention to keep moving, keep peddling forward, but the uncertainty of COVID-19 felt like a heavy burden.

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PHARMACEUTICAL TECHNOLOGY _ New Zealand: A Promising Destination For Trials in A Post-Covid-19 World?

Unlike the rest of the world, New Zealand’s speedy and decisive response to Covid-19 has successfully enabled the country’s clinical trials to continue largely unscathed. Allie Nawrat talks to key actors in the New Zealand clinical space about how Covid-1.

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Successful Patient Recruitment In a COVID-19 World

Pharmaceutical Solutions (PSL), which is New Zealand and Australia-based, has been geographically fortunate, and our proven strategies have also ensured the continuation and success of our clinical studies.

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STUFF.CO.NZ _ Overseas medical researchers eye up NZ for clinical trials

Overseas medical researchers eye up NZ for clinical trials. Jacquie Palmer, managing director of Pharmaceutical Solutions speaks to Stuff about New Zealand being the ideal destination for clinical trials.

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Rapid Study Startup and High Patient Recruitment for US Biotech Clinical Trial

A US-based biotech company was seeking a CRO who could successfully recruit a large number of elderly patients in New Zealand. A challenge squeezed into a three-month recruitment window.

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NBR _ COVID brings boom in clinical trials [New Business Review]

“It’s quite exciting times for the industry, and how well New Zealand has dealt with Covid has really opened up some opportunities." New Zealand’s Covid-free status is attracting more US biotech and pharmaceutical companies than ever to run clinical trials here.

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BLOOMBERG _ New Zealand's COVID-19 response rated best in the world

New Zealand is the best place in the world to be in the coronavirus era, according to the new Bloomberg Covid resilience ranking.

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BetterLife Pharma chooses Pharmaceutical Solutions CRO for Australia coronavirus trial of AP-003

The company has selected Pharmaceutical Solutions Ltd, which specializes in managing clinical trials in Australia and New Zealand.

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Our Managing Director Jacquie Palmer was recently interviewed by Outsourcing Pharma

Our Managing Director Jacquie Palmer was recently interviewed by Outsourcing Pharma on New Zealand’s growing clinical trials industry and response to Covid-19.

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“I wanted to be part of the solution to Covid-19”: Michele Ashby, Executive Director, US

We’re incredibly proud of our Executive Director of Business Development in the United States, Michele Ashby, who is taking part in a US based COVID-19 vaccine trial. Hear from Michele, her insights as a clinical trial participant.

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Pharmaceutical Solutions: Quality Assurance in Clinical Trials

With international travel restrictions in place, many pharmaceutical/biotech/CRO companies have had to place quality assurance audits for their clinical trials on hold.

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Assured Continuity of Clinical Trials in Australia and New Zealand during the Covid-19 pandemic

Confidence in the Australian and New Zealand clinical environment has been shown globally with 170 new study start-ups registered on the ANZCTR between April and August 2019

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2020 Finalist - Westpac Business Awards

​Pharmaceutical Solutions is honoured to be selected as a finalist in the Westpac Auckland Business Awards - Excellence in International Trade category.

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Clinical trial continuity in NZ: Optimal Clinical Trials

Clinical trials are considered an essential service by the New Zealand Government and so can continue to operate at all alert levels

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Moving forward, together

After 102 days, New Zealand has recorded its first new cases of community transmission of Covid-19. As of midday on Wednesday 12th Aug, there are only four cases confirmed, all of which are in Auckland.

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STOCKTALK _ Biotechs set to boom with clinical trial floodgates open

A fantastic discussion about Australia’s clinical trial industry. Jacquie Palmer speaks with the heads of ASX-listed Dimerix Limited and Cynata Therapeutics about how Covid-19 has propelled trial methods forward, and the implications of the pandemic on the future of the sector.

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NEWSTALK ZB _ Call for NZ clinical trials after Govt's $37m vaccine spend

Listen to Managing Director Jacquie Palmer discuss New Zealand’s clinical research potential on NewstalkZB this morning. We’re excited to start a valuable discussion about NZ’s capabilities and opportunities in the clinical sector.

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NZ HERALD.CO.NZ _ COVID-19 and New Zealand’s clinical research sector

"In the global race to find a vaccine, we need populations that have had little exposure to Covid-19 and New Zealand can offer a vital link in the global effort to halt the novel coronavirus," said the group's managing director, Jacquie Palmer.”

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MEDICINES NZ _ Clinical trials in NZ worth $1.2 billion

New Zealand has a window of opportunity to increase market share. Chief executive of Medicines NZ, Graeme Jarvis, says there has to be a collaborative effort between the industry, clinical research sector and government to make New Zealand a bigger player on the world stage.

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Medicines NZ report estimates clinical trials worth $1.2b over 5 years

A new report independently commissioned by Medicines New Zealand estimates that since 2013, clinical trials of prescription medicines have contributed at least $1.2 billion to the New Zealand economy and have benefitted the health system and Kiwi patients.

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