Clinical medical trials play a crucial role in the development of new medicine, therapies and medical devices. These trials are conducted to test the safety and efficacy of new treatments, with the ultimate goal of improving patient outcomes and advancing medical knowledge. There are several stages of clinical trials, each with its own specific goals and requirements.
Still to this day, the personnel conducting trials are using pen and paper to mark down crucial observations. To speed up the trials and provide long-awaited innovation, Estonian MedTech startup Menken Trials is working on a platform that will change everything. It’s not just a simple digital version of the old solution but rather a whole new streamlined solution for it.
Everything needs to be written down
Clinical trials are divided into four rigorous parts. At first, with a handful of volunteers, medical professionals evaluate the possible side-effects, safety and the best dosage. If no serious side-effects occur, then the effectiveness of the medicine is evaluated with a wider number of patients during a second round. For example, does a cancer medicine shrink or stop a tumour from growing, and what dose of medication is the most effective?
One of the most important aspects of clinical trials is the use of randomised, controlled studies. In these trials, participants are randomly assigned to either a treatment group or a control group, which receives a placebo or an existing standard treatment. This helps to ensure that any observed effects are truly the result of the treatment being tested, rather than other factors.
In phase three trials, the medicine is compared to those already available on the market. To do this, thousands or even more patients around the world are needed. The medicine can be sold to the general population only after all three phases have been successful.
As people’s health and lives are in question, everything needs to be protocolled during the trials in minute detail. The scientists, doctors, nurses and patients need to keep track of every potential side-effect and effectiveness of the medicine. This means filling out a lot of paperwork.
Menken Trials is a startup taking clinical trials into the 21st century. It’s not just a paper or digital version of the same things, but a streamlined approach to the trials at large.
With the help of built-in compliance checks, it helps to accelerate the process while keeping quality and error elimination in mind. It offers automated protocol workflows, intuitive quality checks and effective document management. Allowing institutions to close studies more efficiently, with less time and fewer expenses.
From personal need to a thriving business
The founding of Menken Trials is a classical startup story. It grew out of personal need and necessity. Anna-Liisa Parts had worked in the clinical trials industry for over ten years and during that time she faced quite a few problems. One day she asked her brother, Jürgen Lorenz, who happened to be a software engineer, whether and how technology could help to solve the problems she had experienced. Jürgen then contacted his old classmate Andreas Ellervee, a developer with experience in healthcare systems, and together they started to play with different ideas and discussed the possibilities that technology can offer. “We then decided that we should try to make things better,” described co-founder and CEO Lorenz.
Despite the important role clinical studies play in advancing medicine, some experts argue that traditional clinical studies are outdated and in need of modernisation. Critics argue that traditional clinical studies are often slow and expensive. Lorenz said they are not afraid to bring disruption and new thinking to a field that is still accustomed to filling things out on paper to this day. “Our innovation is to make clinical trials more efficient so that doctors and nurses can focus on important tasks like patient management. With the big goal of getting life-saving medicine to market faster.”
Since 2000, the number of tasks professionals need to perform has increased by 60% while the average time it takes to conduct a clinical trial has extended by two to three years over the last decade. This in turn creates frustration for doctors and other personnel who conduct them, according to Lorenz. “Studies have shown that about 50 to 60% of doctors decide to participate in only one trial during their career. We want to make things easier for them to manage. This would then help to bring life-saving medicine to the market faster,” he described.
Yet another reason the sister-brother duo are so eagerly working on their idea is that Alzheimer’s and cancer run in their own family.
Early success with stellar projections
Menken Trials ran a test project with the help of Tartu University Hospital to see how their solution works in the real world. Now they are in the process of being used in a real-world scenario during a clinical trial.
The company has now started the process of entering the US market. Though clinical trials are run internationally, being present in a country where many pharmaceutical manufacturers are located is helpful. Parts says they are fortunate to have exceptional advisors from top eSolution companies who possess valuable insights and expertise that can aid them in their endeavour. “Our clients are the companies producing the medicine, so we want to be closer to them. The regulations for clinical studies are strict all over the world, especially in our home market – the European Union. They are a bit more lenient in the United States,” Parts says.
Lorenz sees that all the work they have put in over the past few years might pay off this year. He is looking forward to a bigger breaking point that will help to reach clients in the US and also in the UK.
The team has taken part in many various startup accelerators. Currently, they are a part of Creative Destruction Lab Estonia which helps them build their platform using data gathered from the world’s most advanced digital society: Estonia.
Menken Trials’ success has not gone unnoticed. They have come out on top in multiple accelerator programs and hackathons, such as Superangel Base Camp and Prototron, and also brought home many prizes from local startup events. Their most recent award came from sTARTUp Day’s pitching competition.