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 biotech and life sciences companies on clinical trials in phases 0 to III. We also collaborate with international study groups and work on international investigator initiated trials (IITs) across a range of therapeutic areas.
All these projects have their own individual requirements and different challenges, such as pediatric rare disease trials and cardiovascular trials. But they also have a lot in common: when we work with clients, we follow the same general collaboration process, from the first meeting to measuring success.
How we meet our partners
Before we can work together on a trial, we must first meet. Our collaborations often start when we meet clients at conferences and Bio meetings – regional ones, like BIO-Europe, and their local counterparts, like BioSpain and BioFIT. Even during the pandemic when this contact became digital, making connections was an important part of our work.
We also make contact through people we have worked with before, who shared their success stories, as well as through our website and LinkedIn profile.
What an ideal project looks like
We want to work with our clients to help improve patients’ lives. Siron Clinical’s expert team has vast experience in complex clinical trials, including various orphan indications and pediatric studies. These sorts of projects match our experienced team’s expertise and enable us to provide the support they need to succeed.
Our objective is to provide our services to the highest quality, within time and budget. We do this in a number of ways, as Jan Balemans, Siron Clinical CEO, explains:
“Our highly experienced group of clinical research professionals not only support but can also advise clients on how to meet the aforementioned objectives. We prefer to seamlessly integrate our team into the client’s project team and to build a partnership.”
Bidding to bring the teams together
The process of building the team that integrates Siron Clinical’s experts with the study team starts with an introductory call in which we review and discuss the client’s service needs. Following that, we receive the request for proposals (RFP), in which the client provides information about the trial. This might include the services they need, the project planning and timelines, the countries involved, the number of sites, and the number of participants. When it’s available, they also share a protocol or protocol synopsis.
All this helps us shape the offer we share. “We discuss the project internally and start preparing the proposal,” Jan says. “It includes information on how we will manage the project and meet the client’s requirements, as well as outlining the responsibilities between the sponsor and CRO. We might also include our responses to any questions discussed during the introductory call.”
If the proposal is accepted, the team schedules a follow-up ‘bid defense’ meeting with the client to review and discuss the proposal and, if needed, make changes, so they can make a decision.
The first step of a project
Communication is key to success in a clinical trial, and that begins at the very start of the trial. “We agree on communication, reporting, and follow-up during a kick-off meeting,” says Jan.
This kick-off meeting is held with the complete project team, which includes the client, Siron Clinical, and others, as needed. It sets the tone and approach for the trial, so it’s important to ensure elements like communication are agreed.
Mitigating risk
Another important element from the very start of a project is risk mitigation. This starts with identifying the potential risk in the preparation phase of the clinical trial and including them in a risk management plan (RMP). We monitor and control the risks throughout all phases of the clinical trial, and we discuss them in regular project meetings. If the ongoing review highlights that a change in the risk assessment is needed, we can update the RMP.
Despite everyone’s best risk mitigation efforts, challenges can still arise, as Jan explains: “Unforeseen challenges can occur unexpectedly during all project phases, and our experts generally resolve these in the routine day-to-day management of the trial. As necessary, problems can be escalated to management or the customer to ensure appropriate action.”
Rounding up a successful trial
Success can mean different things to different parties, depending on the trial itself and the goals shared at the start of the project. At the end of the project, the team holds a final customer meeting in which we discuss satisfaction openly. According to Jan, collaboration is an important factor in the way Siron Clinical measures success.
“Success is when the project team, sponsor, CRO, and others are both happy and proud of the result that has been achieved in good cooperation with each other and when the team is looking forward to the next collaboration.”
Many of Siron Clinical’s collaborations are long-term, and we value the relationships we have built on high-quality work and successful outcomes over the last 20 years.
Read more about how the Siron Clinical team works by going behind-the-scenes, and contact us to take the first step in a new collaboration.
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