Spiral is running the ANZICS Winter Forum iPad competition again!

The prize of a brand new, 32Gb iPad which will be presented on Tuesday the 28th of August immediately prior to morning tea. This is the NEW iPad that supports Apple Pencil!

Here's what we want you to do:

• between now and 8am on the 28th of August post a photo on Twitter
• include the hashtags #ctgWRF2018 and #spinnakersoftware
• follow the Twitter rules with your posts
• make your photos relevant to the Winter Forum
• you can be as creative or trad. as you like
• be in the room to collect your prize, or deputise someone to do it for you (we are not posting the prize)

Here's what we DON'T want you to do:

• create multiple accounts
• repeat your tweet or post duplicates

Here's what we will do:

• the judge (a talented amateur photographer) will look at all the tweets containing a photo that have BOTH hashtags #ctgWRF2018 and #spinnakersoftware
• the judge will decide which photo, relevant to the forum, he likes best
• the judge, alone, will decide on the winner
• our CEO will present the prize at the Winter Research Forum just prior to morning tea

BTW the judge's decision is final.

Good luck! We'll see you in Sydney!

ICU-ROX 1,000 patients enrolled

ICU-ROX has reached its target of 1,000 patients enrolled which means congratulations, not just to Paul Young and Di Mackle, who lead the teams but to each and every person involved. From the patients, to the clinicians, to the research coordinators to the project management team – it’s a pleasure to work with people, like you, who take positive action to change the future!

Congratulations to you all.

What happens when you ask for a change to Spinnaker

So you have found something in your study that needs to change. Heres a small insight into what we do when you ask for a change.

It could be that something in your CRF has changed, you have found a better way to do something or maybe something in Spinnaker is annoying you. Whatever it is, the path is the same and for the purpose of this example lets assume it’s a reasonable request and the change will be applied.

The change may begin with a Research Coordinator in a hospital who contacts the Project Manager with a suggested change.

The Project Manager passes reasonable requests on to us here at Spiral where the change goes through 3 phases …  development, staging/testing, and production. We have an environment for each of these.

Development

New requests for changes are scheduled and assigned to one of our developers. They make their changes and create a new version of Spinnaker for your project. They test the changes work before the next phase …

Staging

Once the changes have been made one of our team checks and tests a few things around the change including testing that:

• the changes made match the request
• the new functionality actually works
• Spinnaker is stable and continues to work as expected

Every project has a staging site which has a combination of the latest Spinnaker code on it and a copy of your study database. We have a whole server dedicated to our staging sites. If anything goes wrong here it’s not going to affect your study!
Then onto the next phase…

Production

When testing on the staging site is completed we schedule a release date. We time the release for a quiet time of day when there are few or no people signed in to your study. During the release we:

• check there is no-one adding or editing a form
• compare the database structure between the production and staging environments
• copy any database changes to the production environment. Only the database structure is copied, not any data.
• copy the new code to the production environment
• check Spinnaker is stable
• tell your project manager about the release

That’s it in a nutshell …. except of course we keep doing this in a continuous cycle because that’s Devops and Agile development!

Past and Future choices

Have you made any New Year resolutions? It’s that time of year when many of us wonder about the fresh new year where we get a chance to begin again, to set new goals and make new choices.

Perhaps you looked back at 2017.  For us, 2017 was our biggest year yet with 11 trials on our books and over 5,200 patients randomised during the year using Spinnaker.

At Spiral we have already made a few choices about what we are doing in 2018, they are:

• adding another server to our flotilla taking our total servers to 6. Five of which will be in Australia where most of our business now comes from
• aligning all our security practices with the ISO27001 standard
• completing 2 projects which are racing towards final delivery in March/April
  • One of these projects is a collaboration between Australia and Sweden,  two trials TAME and TTM2. I’ll write about that collaboration later in the year meanwhile you can read about these trials on our Spinnaker website.   TTM2 Trial »   TAME Trial »
  • The other (REMAP-CAP) is in the final stages of development and is big news for future health both in terms of trial design (it uses our response adaptive randomisation module) and in it being the largest study on severe CAP ever conducted … read more about REMAP-CAP »

With every opportunity presented we have a choice about how we look at it, how we plan and how we act; each new year is a new opportunity.  These are the choices I want to make this year:

• to be curious, to challenge the status quo. This is how we improve Spinnaker and why we are always working on it.
• to be kind. Even in business, kindness is the foundation to good work, not just in our relationships - we try to make our software kind i.e make it easier for you to use!
• to participate. Sometimes the easy option is to do nothing, to participate is to care enough to be part of something.

Best of luck with your choices, following through on them and in gaining some exciting results in 2018.

Merry Xmas

Merry Xmas to everyone using Spinnaker  

 

During the year you randomised patients, published results and initiated new research. 2017 is our biggest year yet with 11 trials on our books. 2017 highlights include:

• over 5,200 patients were randomised this year using Spinnaker
• TARGET(Monash) and NovelSTART(MRINZ) completed enrolments 
• Bryn Gilbertson joined the team to manage TTM2 and TAME
• we added 2 new servers to our flotilla. We named them Platypus and Discovery (yes there is a new Star Trek series out)

Spiral continues to grow because of what you do. Your projects are the reason we come to work each day and the success of your projects is our most important goal. Thanks for being on board and using our software.

 

We are having a break over summer but be sure that OUR SUPPORT FOR YOU NEVER STOPS. 

While you are playing cricket on the beach or eating too much ham, our infrastructure team will be monitoring Spinnaker, making sure everything is running smoothly and that your trials can be accessed when you need them.

 

All the best for the New Year!

O TARGET

Enrolment completed this week!

What a phenomenal achievement from everyone involved in TARGET.  Congratulations because in just 18 months 46 intensive care units in Australia and New Zealand enrolled 4,000 patients.

That's an average of 7.5 patients a day!  

The busiest day was the 4th of August when 25 patients were enrolled. Crazy!

And it wasn’t just enrolling patients and following up … there were so many bags of treatment to reconcile! … and so many large boxes to manage! 

 Congratulations to you all.

We layered up our Firewall in the fight against cyber hacking

There has been a firewall protecting our clinical trial servers (and your data) ever since we put our first project in “the cloud” in 2013. In the past 5 years we have had no incidents but in our striving for excellence we have gone one step further and added another layer of protection.  

In line with increasing threats and the availability of better protection, we have enhanced our firewall protection with additional layers for DDoS Mitigation, Virtual Patching, and prevention of Zero-Day Exploits. The additional firewall adds an extra level of armour to our servers (yes its a war out there!), will help protect your data and reduces the risk of downtime.  

 

How will the firewall do all that?

In a nutshell; all traffic for our #1 server is routed through this firewall where suspicious traffic is trashed before legitimate traffic is passed on to #1 server.  In more detail it will: 

• Block hack attempts. The firewall filters traffic and blocks malicious traffic and attacks
• Stop brute force attacks. Every application in the cloud gets hit with automated hacker tools known as brute force attacks. If login credentials, for your study, are guessed through one of these attacks hackers can gain access to the application. Our new firewall stops these attacks early.
• Mitigate DDoS attacks. Distributed Denial of Service attacks can cause downtime for applications. These type of attacks, where multiple computers and multiple internet connections are used to flood the bandwidth on a server, are a nuisance because they prevent legitimate users logging in.
• Prevent Zero Day Exploits. New vulnerabilities are being discovered by hackers every day. By partnering with firewall experts who have systems to intelligently stop suspicious behaviour we can stop these exploits even if there is no patch.

On with the battle to keep your data safe!

TARGET Case Study Published

As the TARGET Trial races towards the successful enrolment of its 4,000 patients, we are pleased to publish a case study of our involvement in the project.

TARGET involves 46 ICU's in both New Zealand and Australia. The trial commenced in 2016, it has been recruiting at extremely high rates. Enrolments will be completed early, certainly by the end of 2017.

 With over 100,000 bags of study treatment supplied as part of this trial, some smart stock management was needed. Spinnaker delivered on that. We are very pleased we have been able to help with streamlining the inventory management, delivery, reconciliation and patient allocation right into the CRF. Hopefully making your job easier.

You can read the full case study on our trial summary page over on the Spinnaker website.   You will also find a PDF of the case study, PDF of the TARGET Fact Sheet and a link to an interview with the Chief Investigator answering questions about the trial.

Plus has started enrolments

Time to celebrate as the PLUS Trial has begun taking enrolments. 

For the team at The George Institute and us here at Spiral it’s a major milestone. Enrolments mean the completion of the development stage and advancement towards the target of enrolling 8,800 patients. 

Enrolments also mean the first shipments of study treatment have been delivered. The ordering process, the receipt of shipments at each hospital and then resupply are all handled via our software, Spinnaker.

To reach this point we do a lot of testing of the software and the database used in the trial.  Bryn was kept busy for weeks checking that Spinnaker matched what was requested, after which the team at The George Institute got stuck in and tested the clinical side of things. Enrolment time for us is about making sure everything is ready including:

• setting up the monitoring
• cleaning up the database 
• making sure we are available for technical support on go-live day
• copying the project to a development server so we are ready for any upcoming changes or issues

Once the project is “live” and enrolling patients, our work is not finished, we:

• continue to monitor the response speed and activity on the project
• monitor for teething problems
• do extra testing to double check everything is running smoothly
• monitor and manage the servers that host the study software and database

We also have some clever automations that run in the background and make sure things are ticking along with the trial. 

We do this for each project and PLUS was no exception. 

Congratulations to the PLUS team at The George Institute and to all the sites participating in the early enrolments. Today, 25 patients are enrolled with only 8,775 to go!

Congratulations to the winner of the Spiral iPad in Queenstown

We were at the ANZICS-CTG Winter Research Forum in Queenstown last week. It was the most fun I’ve ever had at a conference. I especially enjoyed being able to give away an iPad to the best “conference” photo on twitter.

Congratulations to Samantha Bates for her fabulous photo of The Remarkables reflected in her car mirror and the clever caption that went along with it.

The forum provided an informal opportunity for investigators to gain early advice and feedback on research proposals, to explore issues relevant to study design and conduct in ANZ ICUs and to foster a collaborative approach to study development within the CTG. Five of the trials listed on the program are, or will be, using our software; these are TTM2, TAME, TARGET, PLUS and REMAP-CAP. This was a great opportunity for me to learn more about these and other projects; to extend my knowledge of whats it like in the world of ICU research so I can take that back to the software and improve Spinnaker for the people using it.

The winner along with two of our favourites

Introducing our new Project Manager

Meet our new Project Manager, Bryn Gilbertson. He has been working as a tester for us, testing on the PLUS Trial, and earlier this month accepted the role of Project Manager.

The role had been mapped out and loaded on our website ready to advertise as soon as we received confirmation of our next project. I knew our next project would tip us into securing an extra person to join our team. That project turned out to be the TTM2 and TAME Trials combined (more about that later).

Bryn adapted quickly to our way of working, our customer focus and the matrix of software we use. He has a neuroscience degree; the TTM2 & TAME Trials are looking at neurological outcomes after people have experienced a cardiac arrest and Bryn has been enjoying reading the protocols for both these trials while he gets up to speed on the project.

Read more about Bryn »

See you in Queenstown 23rd-25th August

Spiral is going to the ANZICS-CTG Winter Research Forum in Queenstown. The forum provides an informal opportunity for investigators to gain early advice and feedback on research proposals, to explore issues relevant to study design and conduct in ANZ ICUs and to foster a collaborative approach to study development within the CTG.

We are very pleased and excited to support the ANZICS-CTG community and to attend the forum where we expect to learn more about the trials undertaken by the CTG.

Five of the trials listed on the program are, or will be, using our software; these are TTM2, TAME, TARGET, PLUS and REMAP-CAP. This presents a great opportunity for us to learn more about these and other projects, to gain further insights into the world of ICU research and catch up with everyone that we work with.

Look out for the competition - we will be giving away an iPad for the most relevant photo on Twitter. Details to follow later.

Forum website »

TASI Trial launched this week

This week we launched another study – the TASI Study.

This is a small, low budget pilot trial that will test the potential overall benefit of the TightRope versus syndesmotic screw fixation for ankle injuries. You can read more about it on the Spinnaker website »

The trial has been running for over 12 months using the classic envelope system for randomisation. Patients were previously randomised into this multi-centre trial by telephoning a central coordinator. This placed a significant burden on the coordinator to always be available by mobile phone. In one easily implemented package our randomisation module has removed all that difficulty and put randomising patients in the hands of the local registrars.

With only 160 patients in the pilot there was not the budget for our full Spinnaker package. Our stand alone Randomisation Module is useful and surprisingly affordable package for pilot studies like the TASI Trial.

Your database on steroids

In the space of a week our sys ops have upgraded our clinical trial server in Sydney (Wombat) and added another server to cope with the growth in Spiral and the popularity of our Spinnaker Software.

The server upgrade means Spinnaker just got a whole lot quicker and access to your database is faster. We doubled the random access memory (RAM) on Wombat and added another processor. Monitoring of the server should show some significant gains in speed but already we can see a huge difference in the response time … and you will to.

The new server (Platypus) is also in Sydney but at another location to give us more flexibility about where we place your database. Platypus has the PLUS Trial on it, ready to enrol 8,800 patients in what must be one of the biggest ICU trials in Australasia.

Platypus is part of a long term plan to provide a smarter service and a more agile response. Under consideration is how we respond to server overloads, how quickly and smoothly can we move a single study instance of Spinnaker from one server to another and maintain 100% data integrity. Another consideration is alternative options for key functions, like randomisation and unblinding, during unavoidable downtime.

At Spiral we are all committed to providing a fast, agile response from the database and from our support team to you.
Hope you enjoy the ride with Spinnaker, on your faster database.

Recent visit to Wellington ICU

Recently I visited Wellington ICU where I sat down with their research team to hear from the people using our software every day.

It was an arranged, informal visit where I talked with them about how they use Spinnaker (our clinical trial software). I discovered what they liked, and didn't like, how they structure their workflow during the day and how Spinnaker might help with that. This was great feedback for me, to hear from the people using our software every day, to better understand how Spinnaker is used so we can build these insights into the next version of the software. Its all about making peoples lives easier.

The meeting was arranged by the study trial manager who attended the meeting with me and also found benefit from the discussion.

The meeting was a great opportunity for us all to ask questions, for me to focus on removing some of their hassles. The team asked for some changes which we were able to easily implement such as extra columns on reports - things we had not considered, which were easy to implement and immediately improved workflow for the research coordinators. The remaining insights and changes will be implemented in upcoming releases of Spinnaker.

Last week our team got together at an old lodge in Petone

At Spiral, the team that bring you Spinnaker, we all work remotely. Since we don’t get to see each other very often we have meet-ups roughly twice a year. When you don’t have face to face time with your colleagues every day, seeing each other is special and fun.

Last week our team got together at an old lodge in Petone for one of our regular meet-ups. We’ve had some great meet-ups over the years and engaged in some interesting activities. Each meet-up is a little different and this recent one was all about working together, talking, getting to know the new faces … plus food and coffee of course.

The whole team is at the meet-up and customer support continues through the time we are together. This means that in the middle of a discussion, maybe on how we will scale the server, if a customer support request comes in the discussion goes on hold while someone resolves that. The rest of us have plenty of other things to work on or maybe its time for a cup of tea at that point.

Many of the housekeeping type discussions, like how we are managing our support requests with Zendesk, work better with us all together where we have input from the whole team. At this meet-up there was also a lot of discussion about how we are growing and our direction for the next few months is clearly charted.

Winner of ANZICS NZ 2017 Twitter Competition

I was delighted to attend and sponsor the gala dinner at the ANZICS NZ 2017 Regional Meeting last week. It was great to catch up with the people that we know and to see so many ICU staff from across NZ along with a few special guests from Australia. The meeting was organised by Wellington Hospital ICU, in particular Ben Barry and Karyn Hathaway.

ICU nurses know how to have a good time and let their hair down when they are away from the demanding, stressful environment they work in!

In addition to sponsoring the dinner we offered a prize for posting a photo on Twitter with the hashtags #anzicsnz2017 and #spinnakersoftware. We received over 60 entries for the competition which was judged by an amateur photographer. There were two honourable mentions, Paul Young @DogICUma and Julie Burgess @kiwiburgess. The winner,  Deb Chalmers @ViridescentFrog, posted several images. Thank you to everyone who posted in the competition, there were some creative, interesting and humorous images posted from animals to sunsets … and  a few coffee‏ photos 😮

This is the first year that we have sponsored the dinner and it was lots of fun.

Introducing the PLUS Study

The George Institute of Global Health, Sydney, is our newest client and the coordinating centre for the PLUS Study.  PLUS kicked off in February and will begin taking enrolments in July.

Another fluid resuscitation study for us, the PLUS Study is a multi-centre, blinded, RCT.

PLUS tests the hypothesis that:

"in a heterogeneous population of critically ill adults, random assignment to Plasma-Lyte 148® for intravascular volume resuscitation and crystalloid fluid therapy in the Intensive Care Unit (ICU) results in different 90-day all-cause mortality when compared with random assignment to 0.9% sodium chloride (saline) for the same treatment."

Of note:

• with 8,800 patients this will be our biggest study
• the study uses our inventory module to track all treatment from shipment to disposal
• the study will initially run in Australia and New Zealand with other countries coming on board later

Next Tuesday I am off to Sydney to meet with the project manager and chief investigator for a sanity check which will ensure the project is going in the right direction. In the meeting we will take a strategic look at the project, discuss the more complex issues in the project and and check-in on our assumptions. I always enjoy these get togethers and once we are underway I find it important to make sure we are all walking along the same path with the project.

It’s always good to see people face to face and I regularly pop across the Tasman to meet with the project admins or join in a team meeting, even if just for an hour, although sometimes I can spend six hours with a project manager, nutting out detail. Mostly I can get across the ditch, and back, in a day but I am always happy to stay longer and use the opportunity to catch up with some of our other trials that are underway.

Read more about the PLUS Study »

Working smarter with online software

Spiral is a distributed company ...we are the ones that bring you Spinnaker! Distributed means our team work from homes and offices across New Zealand. Its a great way to work, it enables us to be focused, work smartly and avoid earthquake issues!

We rely heavily on great communication and technology and I thought you might be interested in some of the software tools we use:

• Skype. For video and voice calls with customers and internally. We use the screen sharing function on Skype a lot
• Slack. For team chat and water-cooler type conversations.  Some of our other apps are  integrated with Slack so that we get messages when stuff is happening on other channels
• Bugherd. For reporting bugs and issues with Spinnaker. Some customers will recognise this one because you are using it
• dapulse. Gives us a way to visualise all our projects and deliver working, robust software in a timely manner
• Inspectlet. Records peoples behaviour using Spinnaker which we translate into improvements to our software that make your experience of it better or quicker
• Highrise. CRM that helps me stay organised

Im currently evaluating Zendesk but thats a story for another day.

My desk - a distributed office environment can look like this. 

Thanks for being on-board

Thanks for being on board and for your support this year. We have more projects open and trials taking enrolments than any other year and we couldn’t do that without your support.  What a year!

Supporting your research is why we come to work each day. Here are some of the highlights in our year:

• over 1,480 patients were randomised using Spinnaker
• Deb Gilbertson joined the team at Spiral in the role of development support
• we entirely rewrote the user-permissions module for Spinnaker ready for more complex studies
• we started work on ANZ’s first response adaptive platform trial (REMAP-CAP)

Like you we have been working hard through the year. To recharge and get ready for 2017 we will close on the 22nd of December and reopen on the 16th of January 2017.   

OUR SUPPORT FOR YOU NEVER STOPS. While you are playing cricket on the beach or eating too much ham, our infrastructure team will be monitoring Spinnaker, making sure everything is running smoothly and that your trials can be accessed when you need them. 

Merry Xmas from everyone @ Spiral