Thursday, December 16, 2021

It's official! The Panoramic trial is all go!

Recently we announced our involvement in another incredibly exciting trial, aimed at finding effective treatments for people in the community which will prevent people from being hospitalised with Covid-19.

This trial was awarded funding through the National Institute for Health Research (NIHR) to work with several UK universities and carry out a first-of-its-kind clinical trial, testing novel antiviral COVID-19 treatments for use early on in the illness by people in the community with COVID-19 who are at higher risk of complications.

Known as PANORAMIC, this trial is led by Oxford University’s Primary Care Clinical Trials Unit, while the delivery of the trial will be supported by the NIHR Clinical Research Network and devolved administrations.

In a new development, we’re thrilled to report that the UK government has announced that thousands of the UK’s most vulnerable people will be among the first in the world to access these life-saving, cutting-edge antiviral and antibody treatments from December.

“This opens up a new era for the treatment of COVID-19, one where we can begin to cover every phase of contracting this deadly disease – whether it be before you catch it, just after you catch it, if you develop symptoms or if you require hospital care.” - UK Health and Social Care Secretary Sajid Javid

The study will be trialling the use of Molnupiravir, an anti-viral drug shown in clinical trials to reduce the risk of hospitalisation or death for at-risk, non-hospitalised adults with mild to moderate COVID-19 by 30%.

Taking part in the study will require participants to complete a daily diary for 28 days through the PANORAMIC website or receive a phone call from the trial team on days 7, 14 and 28 to speak about their symptoms. The first set of results from the trial is anticipated in early 2022.

Spiral will be supporting with our savvy software platform and our ability to pivot with change. Unlike others, we can adapt our platform for Novel Trials or studies that use unusual design methodologies. We’re excited to keep you informed about this groundbreaking trial - one that we feel privileged to be a part of.

Keep up to date with the Panoramic trial via our Trial Hub page here. We will be refreshing it with new information as and when it is made available.

Dive Deeper:

Press Release - UK’S Most Vulnerable People to receive life-saving Covid-19 treatments in the community

Monday, November 15, 2021

Meet Adam - One of our developers here at Spiral

Meet Adam. As the newest member to join our Spiral team, Adam has been with us for just over 6 months but has already brought with him a wealth of enthusiasm and keenness to take on a challenge.

Becoming a developer was not a career Adam had initially planned for. Although he always had an interest in subjects like science and software, Adam fell into hospitality, working as a chef for 10 years as a way to support his studies in mechanical engineering. 

Now based in Wellington, Adam and his partner had been living in Germany for the last three years. However, like many Kiwis abroad, the outbreak of Covid forced them to reconsider their options, resulting in a move home. Realising he was no longer challenged in his current role, the move allowed Adam to reassess where he was in his career and make the decision to start fresh.

A software development boot camp in Wellington kickstarted his journey on his new career path. Not long after, a job posting for Spiral came through his career advisor. This immediately piqued Adam’s interest and so he contacted Audrey the same day. A job interview led to an offer and the rest, as they say, is history. 

‘I feel lucky that Audrey decided to take a chance on me, considering I was new to the industry and a bit older.’

Although still relatively new to the role and the industry, Adam loves the challenges that every day brings. He’s the kind of person who loves to push himself and enjoys overcoming obstacles. With software engineering, you don’t necessarily know the answer straight away but it’s your job to go and find the best solution. This is an aspect of the job that Adam particularly enjoys. 

Having been used to working in busy, cramped environments like kitchens, working remotely from home is a new experience for Adam but one that he is acclimatising to well. He enjoys the flexibility it brings and the lack of distractions. Despite having met his team in real life only a handful of times, he already feels like he knows them well thanks to online meetings, Slack and Facetime. 

‘All the people I interact with are really smart and on to it, I feel lucky to work alongside them as well as our clients - it’s inspiring.’

Although happy to leave his hospitality days behind, there are some values that Adam has brought forward into his new role: 

‘If you’ve got time for leaning you’ve got time for cleaning’ 

A saying most often heard in the kitchen, Adam likes to apply this to his work at Spiral, knowing that there is always something that he can be putting his best effort into. He’s also the type of person who isn’t happy settling for ‘good enough.’ Adam likes to set high standards for himself and those around him and operates accordingly. 

While cooking is still something he loves to do for friends and family on the weekend, he is much happier solving problems daily in his role at Spiral, knowing that his work is creating a tangible difference in the world.  

‘My role is busy and challenging and at the same time it’s incredibly rewarding - that’s what I love about it.’

Tuesday, November 02, 2021

Spiral joins first-of-its-kind clinical trial - continuing the fight against Covid

Spiral is pleased to announce our involvement in another incredibly exciting trial, aimed at producing effective Covid-19 treatments for people in the community, not admitted to hospital.

Researchers from the Nuffield Department of Primary Care Health Sciences, University of Oxford, have recently announced that they have been awarded funding through the National Institute for Health Research (NIHR) to work with several UK universities and carry out a first-of-its-kind clinical trial, testing novel antiviral COVID-19 treatments for use early on in the illness by people in the community with COVID-19 who are at higher risk of complications.

Known as PANORAMIC, this trial is led by Oxford University’s Primary Care Clinical Trials Unit, while the delivery of the trial will be supported by the NIHR Clinical Research Network and devolved administrations.

Professor Paul Little from the University of Southampton and Co-Chief Investigator has said:

‘This trial will be one of the most ambitious ever undertaken in UK primary care, and will provide vital information about treatments to help the most vulnerable people in the ongoing fight against COVID-19.’

Spiral will be supporting this trial with our savvy software platform and our ability to pivot with change. Unlike others, we can adapt our platform for Novel Trials or studies that use unusual design methodologies.

CEO and Founder of Spiral, Audrey Shearer has said:

"We have a lot of experience with platform trials including the world-renowned REMAP-CAP Trial which is seeking effective Covid-19 treatments for critical care patients. Supporting the team at Oxford University gives us the unique opportunity to help in the search for antiviral treatments that will be effective early on in the disease (PANORAMIC) and in severe cases of the disease (REMAP-CAP). Our sincere hope is that the antiviral treatments included in PANORAMIC will prevent worsening of the disease and stop people from being admitted to hospital."

PANORAMIC also has two sub-studies – the Post Exposure Prophylaxis sub-study will test whether antiviral agents prevent transmission to people living with someone who gets COVID-19; a Virology sub-study aims to find out whether the new treatments reduce viral shedding and if using the new drugs cause the virus to become resistant to treatment.

Keep up to date with the Panoramic trial via our Trial Hub page. We will be updating it as and when more information is made available.

Monday, September 06, 2021

Case Study - PLUS Study and The George Institute for Global Health

When it comes to clinical trials, we look to make a difference around the world with our savvy software platform. We speak to Sharon Micallef, a Senior Project Manager from The George Institute for Global Health, about her experience working with the team at Spiral to produce a database for her latest study.


With 20 years of experience behind her as a nurse and an intensive care research coordinator, Sharon Micallef understands the demands and pressures of working within a hospital environment. Now a senior project manager at The George Institute for Global Health, a leading independent medical research institute, she has spent the last ten years working in the Critical Care Division on academically-based studies, drawing on her previous experience to help run trials that will benefit critically ill patients.    

Based in Sydney, her latest study, PLUS (Plasma-Lyte® Vs Saline) is a multi-centre, blinded, randomised, controlled trial (RCT) which will determine whether fluid resuscitation and intravenous fluid therapy with a “balanced” crystalloid solution (Plasma-Lyte 148®) decreases 90-day mortality in critically ill patients requiring fluid resuscitation when compared with the same treatment using 0.9% sodium chloride (saline).

Essentially, the study has been comparing two types of intravenous fluids that are used as standard care in ICUs in Australia and New Zealand. There has been an ongoing discussion about the high chloride content in saline and its potential to cause acute kidney injury, but they wanted to know, is Plasma-Lyte safer? Sharon’s study needed to easily and efficiently compare these two standard fluids for patients that require fluid resuscitation in ICUs.

With over 5,000 patients enrolled across Australia and New Zealand, it was vital to create a study database that was designed in a way that made inputting information on the frontline as easy as possible. Halfway through the initial study database design, Sharon came to the realisation that it was too complicated from a research coordinator’s perspective. 

“If your research coordinators find it hard to work with the database, it impacts on the study, recruitment, speed of entering data - the flow-on effect is huge”

Knowing that the current format would slow down recruitment, Sharon decided that something needed to change - and fast. Having worked with Spiral before on the HEAT study several years ago, Sharon felt that engaging with our team would be the right way to go, even if it meant a setback in the timelines of the study. 

A conversation with the PLUS study Chief Investigator Professor Simon Finfer led to a meeting with our Founder Audrey, and work got underway almost immediately and - as they say - the rest is history. This change in the database meant an 8-month delay in starting recruitment but Sharon believes it was worth the wait. 

“I tell everyone it is worth putting that effort in at the beginning. In the end, we haven’t needed the data validation resources other studies require because it was so beautifully done by Spinnaker - I’m very grateful to Audrey and the team - we have a great working relationship”

The bespoke design process was something new to Sharon and she admits being thrown in the deep end. Sharon provided paper forms to work from (randomisation, baseline etc). Our team were then able to design a similar electronic format. 

“There was a lot of hard work involved but Audrey and the team were extremely patient with me”

With her own personal experience front of mind, Sharon understood the wants and needs of both ICU nurses and research coordinators and was able to translate this to Spiral. It was imperative that the functioning database required very few steps, making the randomisation process as easy as possible for the nursing and medical staff who were physically inputting the information while attending to a critically ill patient. This need underpinned the entire trial. 

“Throughout the process, I would think to myself: what would I want if I was working at the other end? What would make my work easier?”

While the results of Sharon’s study are still embargoed, she could say that working with Spiral and the use of Spinnaker has made the process so much easier. Being able to access reports and blinded data all the way through the study has made things so much more efficient.

To give some background on this, study databases traditionally work with something of a data management ‘middle man’. Meaning that if a report is needed, it has to be requested through data management, taking a few days to return before anyone can review the data and check for inconsistencies. But with the use of Spinnaker, if Sharon needs a report with specific data, she can simply download a blinded report,  filter data, check for inconsistencies and send data queries to sites straight away. Sharon believes the ease with which she is able to access and review everything herself saves so much time. 

“It is undoubtedly one of the best features.”

When looking to the future of trials, Sharon believes that a good database is absolutely essential. Without one, timelines can stretch out endlessly, making the trial seem impossible to complete. Whilst Sharon has mostly worked on randomised controlled trials, she loves the way that Spiral has been able to embrace platform trials where multiple treatments are tested at the one time.

Personally driven by the power of clinical research, Sharon is an advocate for any product that enables researchers to conduct trials more efficiently, which in turn benefits people and patients in the long run. Her inherent need to help people through her study, research and trials is made all that much easier with Spiral. 

“Spiral has been amazing, I have had a great time working with them. They have been very professional and answered all my questions, even the silly ones. I have learnt a lot from Audrey and the team. I would highly recommend them as a company and their product to anyone really. It makes my job a lot easier.”

Friday, August 06, 2021

Full-dose blood thinners benefit moderately ill COVID-19 patients

REMAP-CAP, an application in Spiral’s study manifest, has recently been used in a collaborative clinical trial that focused on identifying effective treatments for critically ill Covid-19 patients.
tment options.

Thrombosis was considered to contribute to morbidity and mortality in Covid-19. It was hypothesized that therapeutic anticoagulation would improve outcomes in critically ill patients with Covid-19.

An open-label, adaptive, multiplatform, randomized, clinical trial was conducted. Patients with severe Covid-19, defined as the requirement for organ support with high flow nasal cannula, non-invasive ventilation, invasive ventilation, vasopressors, or inotropes, were randomized to receive therapeutic anticoagulation with heparin or pharmacological thromboprophylaxis as per local usual care.

Trial data analysis involved 1,074 critically ill and 2,219 moderately ill patients. Physician investigators gauged how long participants were free of organ support up to 21 days after enrolling in the clinical trial. The investigators discovered that in moderately ill patients full-dose heparin reduced the need for organ support compared to those who received lower-dose heparin. By contrast, for critically ill patients, full-dose heparin was associated with a high probability of a worse outcome.

The worldwide multi-platform trial spanned five continents in over 300 hospitals to urgently test blood thinners on both sets of patients, the critically and non-critically ill.

The results have shown that full-dose anticoagulation with the blood thinner heparin improves survival outcomes and reduces the need for vital organ support such as mechanical ventilation in moderately ill COVID-19 patients, but does not yield the same positive outcomes among critically ill patients already requiring life support.

As summarised by Professor Steve Webb, director of REMAP-CAP: “Our conclusions have set a new, accessible and affordable standard of care for moderately ill hospitalised COVID-19 patients around the world using a familiar drug. As such the results of the trial can be immediately applied,”

These results come at a crucial time when Australia is dealing with outbreaks in several states, therefore there is renewed interest in treatment options.

Spiral is proud to be a part of this worldwide multi-platform trial, one that spanned five continents in over 300 hospitals, helping to urgently test blood thinners on both sets of patients who were ill or critically ill with Covid-19.

Dive deeper:

The REMAP-CAP Website

Thursday, August 05, 2021

Meet Emma - One of our Project Managers at Spiral

Meet Emma. As a Project Manager, Emma wears many hats here at Spiral. Her main role is to oversee the software development used in clinical trials all around the world, but on any given day you can find her jumping from testing to managing sprints, answering support tickets, developing wireframes or liaising with clients on Zoom.

 “It is an incredibly agile environment. Whatever comes my way - I jump on it and deal with it”

When Emma left school, she thought a career in tourism would be her calling. She completed her degree but a casual job at a pet store led to seven years as a vet nurse. As an animal lover, it was the space Emma thought she would be in for the rest of her career but she found that some aspects of the job took a huge emotional toll on her.  

Deciding it was time to leave this role behind, her career went down a different path as she took the plunge into IT. Having no previous experience she managed to get her foot in the door of a large corporation. Emma found she excelled within this industry - it even took her to Silicon Valley where she and her husband worked within a Kiwi-owned IT company.

Upon her return to New Zealand, Emma took up a senior role at an HR Technology SaaS company. This role lasted for six years until Covid struck, causing her job to be made redundant. Despite this, Emma enjoyed success with several contract roles following her redundancy. When looking for the next step in her career, she came across an advert for a Project Manager at Spiral and couldn't believe what she was reading. The company was doing things she could be passionate about and be rewarded in facilitating.

“I thought, what is the catch? This is too good to be true”

Now living in Tauranga and working remotely for Spiral, Emma wonders why she hadn’t got into this space earlier. She loves the flexibility of working remotely with the support of her colleagues. She compares it to her past experience in open-plan offices where it was easy to get interrupted or feel like she could never fully complete a job to her satisfaction.

“I love working from home. Corporates that are trying to maintain the traditional office environment haven’t given remote working much of a chance to see how well their employees can perform.”

Looking back Emma realises just how valuable her experience has been to get her to where she is today. Two very unlikely industries have collided to provide her with the skill sets that she uses every single day at Spiral. She owes her medical knowledge, understanding of the jargon, and even pronunciation of certain medicines to her vet nurse experience. On the other hand, her years within the IT industry have given her the valuable background to oversee the software development at Spiral. 

“My job history has come together and manifested in a role that I never knew was possible.” 

When reflecting on the challenges of the role, Emma admits there are stressors involved. The juggling can be difficult at times but that is part and parcel of working in an agile environment and with so many people putting their hands up for trials, she feels the need to help everyone. 

The pressure to get it right can be immense. Emma and the team are dealing with sensitive issues every day while liaising with staff in hospitals who are on the frontline of the pandemic. But despite this, she can wake up each day knowing that she is doing something meaningful with Spiral, that her job has a purpose and is making a difference in the current world we’re living in. 

“It is easy to get caught up in the emotions of this role but at the same time, it is incredibly rewarding.”

With her one-year anniversary at Spiral just around the corner, Emma feels like she has found herself a role where she can support others to be the best they can be while at the same time, work within a team that ‘keeps it real’ and bands together.

“This really is the dream job. The team spirit and support is amazing- everyone is so genuine and kind - I feel like I've finally found the right role for me and my long term career. I can't imagine doing anything else now.”

Tuesday, June 29, 2021

TTM2 Trial: Hypothermia vs. Normothermia after Out-of-Hospital Cardiac Arrest

A project in Spiral’s study manifest, has recently been used in the long-awaited TTM2 trial. After successful resuscitation, patients who survive a cardiac arrest often remain severely ill and require intensive care. Controlling body temperature is a potential treatment that may prevent brain damage. The TTM2-trial aimed to study the impact on all-cause mortality of targeted hypothermia compared with targeted normothermia.

Monday, May 31, 2021

Meet Jess, one of our Project Leads

Ask her what a typical day or week looks like and Jess can’t help but laugh. 

 “Every day is different and every week throws up new challenges. I find myself to be very busy. The pressures of the pandemic are immense and with the trial being responsive, the build constantly needs to hear of working in an agile environment but this really is as agile as it gets.” 

Monday, March 29, 2021

Spiral donates Chromebooks to help UK students during COVID-19 lockdowns

It’s been over a year since COVID-19 struck the world, and at Spiral we continue to think about the impact it has on our most vulnerable people – and not just in a clinical context. 

With many schools around the world in lockdown, students are expected to learn from home with online lessons. But what happens when a family doesn’t have a device? Or just one device to share between children? 

With this in mind, Spiral recently donated four new HP Chromebooks to Grange First Primary School in the UK. They’re a low decile school in one of the more economically challenged parts of London, and while the government had provided some Chromebooks to assist at-home learning, they were still short. That meant children were having to join lessons from their parent’s phone, or in families with more than one sibling, share devices. This often meant that one or more siblings simply didn’t get to do lessons that day. 

Tuesday, February 23, 2021

Stew Duff, who makes what we do at Spiral technically possible

He’s not a researcher signing up patients for life-saving clinical trials – but he does determine eligibility.

He’s not a doctor, or a nurse, seeing patients and delivering recovery results – but he does do patient follow-ups and reporting. 

He’s not on the front-lines, but he is helping to save lives from the back end.

 Meet Stew, one of our Developers »

Wednesday, February 10, 2021

Application barnacle scraping

Our developers have been engaged in "barnacle scraping" this week. 

Like the hull of a ship, software needs to go through periodic barnacle scraping, especially when we are making lots of changes and adaptations. Adapting our software platform for COVID research studies has pretty much become the norm for us. All those adaptations leave "barnacles" or little extras which are extraneous to the functioning of the platform and can slow things down. 

We can do all this while the software application continues to run so carry on as usual.  The changes we have been making will improve performance, speed up response times and make things smoother for you.

Thank you for your comments and feedback. 


Friday, January 01, 2021

Happy New Year 2021


This past year has been one for the record books! We just want to say how grateful we are for your support and we’re wishing you all the best as we enter a brand new year.

Head on over to our blog to find out what we are up to »