Choosing a partner to support your clinical trial is a big decision, and understanding what your collaboration might look like can help. After more than two decades of working with a multitude of clients, Siron Clinical has perfected the process from RFP and trial kickoff to measuring success. In this blog post, we take a look behind the scenes at Siron Clinical to give you insights into our process. Since our first collaboration with a Swiss biotech startup in 2004, Siron Clinical has expanded its portfolio. Today, in addition to biotech startups, we work with a variety of small to medium bio ..read more

In the fast-moving field of clinical trials, it can be challenging to keep up-to-date with the latest news, views, and changes. But with new regulation frequently appearing around the world and technological innovation changing the face of clinical research, it’s more vital than ever to stay ahead. So how can you do it? In this blog post, we look at some of the ways to track the rapidly changing clinical trials landscape at the global and national level. There’s an overwhelming amount of information available online about everything, including clinical research. At the time of writing, a Googl ..read more

Now nearing the end of their second year in use, the EU’s Clinical Trial Regulation and its associated Clinical Trials Information System (CTIS) have meant some big changes for sponsors and others involved in designing, getting approval for, and running clinical trials in Europe. What does this look like in practice? Since the end of January 2023, it has been mandatory for sponsors to use the CTIS when applying to start a trial. Usage is in full swing: at the time of writing, there are 43,692 trials registered on the EU Clinical Trials Register. “As with most new systems, CTIS has its technica ..read more

Quality assurance is a critical element of a clinical trial, as it ensures the safety of the participants, as well as the reliability and integrity of the documentation and data, and therefore the validity of your results. But what does it entail, when should it happen, and how can you get it right? We share our insights. In order to ensure the results of your clinical trial are valid and compliant, it is important to undertake quality assurance. Quality assurance (QA) is a set of processes through which you can systematically ensure your trial meets certain standards, such as ethical or data ..read more

With new regulations and guidance promoting transparency, growing calls for better representation, and accelerated developments in technology, the clinical trials landscape is changing continuously. Here is a round-up of the big trends of 2023 so far. At the end of 2022, we shared our predictions of the big trends we expected to see unfold in 2023, focusing on decentralization, technology, and transparency. Now, halfway through the year, these topics are making headlines around the world, and people are at the heart of the discussions. Participant recruitment and diversity This year’s Clinical ..read more

Cardiovascular clinical trials are essential in developing interventions like treatments and medical devices for a wide range of cardiovascular diseases. The sheer size and complexity of cardiovascular trials is just one of the factors that make this therapeutic area stand out. Here, we share some of Siron Clinical’s insights. According to the World Health Organization, cardiovascular diseases (CVDs) are the world’s leading cause of death, with 17.9 million people dying due to heart attacks, strokes, and other CVDs every year. Clinical research has led to many successful interventions to preve ..read more

Finding and enrolling patients can be one of the most challenging aspects of setting up a trial – and even if you reach your recruitment goals, you face the task of retaining those participants for months, years or even decades. But participants are at the heart of every trial, so how can you master recruitment and retention? People are at the core of every clinical trial, and they’re also who benefit when a trial succeeds. But when recruitment stalls or goes wrong, the trial can be derailed. According to research, more than half of trials terminated (55%) ended because of low recruitment. Eve ..read more

It can be disappointing if your trial generates negative results; you may feel it has been a waste of time and resources. But negative results do not necessarily mean failure. If you’re facing negative results and wondering what to do next, it can be helpful to consider the value you and the wider scientific and medical world can gain from those results. Especially given the cost of failure: a failed phase III trial does not only cost the resources it took to run that trial, but all the research leading up to it too, plus efforts to explore an alternative intervention. Failure is costly but co ..read more

Medical devices are vital for diagnosing, treating and monitoring diseases, saving lives and keeping us alive. There are about 2 million medical devices on the market today, in more than 7,000 categories. Each of them underwent a journey from innovation through clinical trials to the market. Here we look at medical devices, the challenges you can face with a trial and how to overcome them. Small biotech companies are driving innovation in the clinical world, and medical devices are no exception. Small companies like these are well suited to innovating and can break the mold faster than their l ..read more

Many trials employ a specific person to manage their TMF – a TMF Study Owner – who can not only ensure the TMF is up-to-date and compliant but also report back on progress against key performance indicators (KPIs) and identify any documentation gaps or timeline slips. However, even with a dedicated team member, a manual TMF can be unmanageable, especially for a large or complex clinical trial. This is where technology becomes essential: electronic trial master files (eTMFs) have revolutionized the way we track clinical trials. At Siron Clinical, we have been partnering with eTMF provider Montr ..read more