At Siron Clinical, we are proud of our specialized therapeutic expertise in tackling complex clinical trials. Over the last 20 years, we have worked on 120 trials including orphan indications, pediatric, cardiovascular, oncology, hepatology and dermatology studies.
For us, a successful trial requires strong collaboration between us and the client, and the result is that we have had many long-term partnerships spanning multiple international trials. The words of our clients reflect the positive outcomes of this collaboration; here you can read a few of the stories.
Spotting Risks In An Oncology Study
There are about 140,000 clinical trials listed for cancer-related treatments. Oncology is a significant therapeutic area that includes more than 100 types of cancers and neoplasms. We have worked on oncology trials for two decades, including on trials for breast, ovarian, pancreatic, prostate and colorectal cancer, Non-Hodgkin Lymphoma and advanced solid tumors.
One of the trials we worked on was a randomized, double-blind, phase III trial for patients with Familial Adenomatous Polyposis (FAP). The aim was to compare the efficacy, safety, and pharmacokinetics of the IMP/sulindac combination versus IMP and sulindac as single agents. The trial would run for four years (48 months) and involve 171 patients across 21 sites.
The client was US-based, and the trial included 38 patients at 3 sites in the EU. They said: “In the beginning, we had no experience in getting studies approved in the EU, Siron Clinical played a vital role in us acquiring approval. Their management and oversight was a very positive experience for us.”
Our extensive experience also means we’re familiar with the particular issues that arise with this type of trial, so we’re able to spot potential risks before they become problems. The client added:
“Throughout the process, we depended on Siron to notify us of potential risks – and typically, they came with proposed solutions. Where Siron had utilized their relationships or learnings from repeated submissions on our behalf to Regulatory agencies or ethics committees, the larger CROs had difficulty communicating prior learnings to internal teams and creating the same kinds of efficiency”
Getting Under The Skin Of Dermatology Trials
Our oncology experience overlaps with our work on dermatology trials – we have supported studies on treatments for things like T-cell lymphoma and solid tumors, for example. We have done a lot of work in early phase dermatology, which has given us the experience to help startups move forward and lead them through the complex clinical trial process.
With one dermatology client, we worked on 15 phase I/II studies. The client described our collaboration: “We have been working with Siron Clinical for over five years, involving fifteen clinical trials and they have been an integral part of our success. As a US-based company with no operational presence in Europe, our partners for working there are critical to us. We need local partners whom we can truly rely on; whom we can trust absolutely. Siron is that partner.”
“The Siron Clinical organization is “vertically involved” with our projects. The senior management is directly and knowledgeably involved in our studies from the inception to the close. This is one of the many unique attributes that they have.”
In a long-term collaboration like this, it’s important that the client can trust that we have all the bases covered. Our project management experience and attention to detail are vital elements of this. The client continued:“The Siron Clinical organization is efficient and nimble, and very in tune with our needs. All projects have started quickly and smoothly, and all activities are timely and precise. The Siron Clinical team is very proactive, with a focus on solutions to any problem that might arise.”
For us, having specialized therapeutic expertise helps us engage on a deeper level with the trials we support. This strengthens not only the trial itself, but also the collaboration with the client. They concluded:
“Many of the studies that we are doing involve innovative research in the early phases of product development, utilizing novel research tools including intensive imaging along with multiple laboratory biomarkers. With non-standard techniques often employed, the flexibility of the Siron team allows us to utilize these innovative methods while maintaining compliance. In addition to the operational expertise in study conductance and oversight, the Siron team is also intellectually invested in the purpose and outcomes of our research. This provides for an excellent relationship with the Investigators and scientists conducting the studies.”
The results speak for themselves: we have supported many successful trials in terms of the outcomes, including the trial for peanut allergy treatment, which was recently approved as the first of its kind. But the underlying result is the successful relationships we build with clients around the world. By collaborating with us as an expert CRO, companies set themselves up for success.