Number of patients 171 (EU: 38)
A randomized, double-blind, phase III trial will compare the efficacy, safety, and pharmacokinetics of the IMP/sulindac combination versus IMP and sulindac as single agents with up to a 48-month maximum treatment period in patients with Familial Adenomatous Polyposis (FAP).
“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.
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”
>500 globally for all studies
Globally up to 170 sites; Siron EU, Israel, and Turkey up to 50 sites
Multiple studies across approx. 10 years
Multiple studies including pediatrics
A Phase 3, Double-Blind, Placebo-Controlled Trial and Long Term Safety Extension of IMP in Patients with Primary Biliary Cirrhosis
A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study to Assess the Effects of IMP in Pediatric Subjects with Biliary Atresia
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of IMP on Clinical Outcomes in Subjects with Primary Biliary Cholangitis with event-driven study design.
“I was first introduced to Siron Clinical nearly 10 years ago. Over the years, we have expanded in size, number of studies, and EU countries and brought on additional Siron Clinical CRAs (approximately 15) to help us manage the work in their region. Every one of them came with excellent experience. The quality of their staff assigned to us was excellent.
We worked with several excellent Siron Clinical CRAs over the years and eventually, one of their leads with whom we’d worked since inception (and before), served in a CRA Manager role for us on a key pediatric study, offering her leadership, actually, to one of our more junior project managers.
We counted on a number of CRAs who worked with us over time and across studies, and came to know their work well over the years. Often, we depended on Siron to notify us of potential risks – and typically, they came with proposed solutions.
One key example of this was with our regulatory submission – 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.”
Multiple Phase I/II studies (a Total of >10 projects)
Sites: Phase I Unit
“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 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.
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.
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.”
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