Each of Siron Clinical’s expert CRAs has at least 15 years of experience in clinical research, and our work over the last two decades spans many specialist therapeutic areas and study types.
One of the key drivers of our success as a contract research organization (CRO) is our extensive experience with clinical trials across phase I and II trials, and in therapeutic areas including dermatology, oncology, pediatric and orphan indications.
With in-depth knowledge and expertise in a range of areas and experience across different study types, we can guide clinical research organizations in the biotechnology, life science, and medical device industries.
Clinical Trial Phases
Clinical trials happen in phases, from phase 0 – trialing pharmacodynamics and pharmacokinetics – to phase IV – continuous monitoring. While we support a variety of trial types, our main expertise is in phases I, II and III.
Phase I is the safety trial. The drug is tested on a small number of people to assess its safety and side effects and determine the safe dosages for further trials. These early stage trials need different approaches to clinical monitoring.
Our phase 1 experience includes:
– Phase I SD/MD PK/PD healthy volunteer studies
– Phase I SAD/MAD PK/PD studies
Phase II is efficacy testing with a control group versus a test group. In this phase, the drug is tested on a larger group of people with the aim of determining the optimal dosage (done in phase IIa) and efficacy – how well the drug works (phase IIb).
Phase III have the main objective to verify the therapeutic action in a larger number of patients.
Most of the trials Siron Clinical has worked on in the last 20 years have been phase I, II and III trials, and we support the process from preparation of the application all the way to helping finalize clinical trial results and closing the trial. Trials in this phase can be complex; we outlined the step-by-step process in a recent blog post.
Expertise across therapeutic areas
Our specialized therapeutic expertise spans a range of areas. This is a key factor in our success; in addition to the knowledge that is useful across all trials, each therapeutic area has its own challenges.
Since Siron Clinical was founded in 2000, we have been working on trials of orphan drugs for rare diseases. Orphan indications cover a broad range of diseases and medications, and because of this variety, it can be challenging to develop a standardized approach to trials that ensures all patients’ needs are met.
We have worked on trials for a number of orphan indications, including Primary Biliary Cirrhosis, Familial Adenomatous Polyposis and Alpha-1 Antitrypsin Deficiency.
Our successful trials include the PALFORZIA trial with Aimmune Therapeutics. The complex phase III clinical trials resulted in the first and only oral immunotherapy for peanut allergy in patients aged 4 to 17 years old.
The PALFORZIA trial was also a pediatric study. Pediatric trials are different to adult trials, and they require specific expertise throughout. In addition to peanut allergy, our experience includes Pediatric Pulmonary Arterial Hypertension and Biliary Atresia.
Our extensive experience with cardiovascular trials includes interventional and device studies. On the interventional side, we have worked with trials of treatments for Hypertension, Unstable Angina, Myocardial Infarction, Catecholamine Resistant Hypotension and more.
Our experience with trials of cardiovascular devices includes Drug Eluting Stent, Renal Ablation and Aortic valve replacement (TAVI).
Oncology is another area we have worked on since the beginning. As a result, we have a deep understanding of how to navigate the complexities inherent in oncology trials. Our experience covers many areas, including Advanced solid tumors, Breast, Ovarian, Pancreatic, Prostate, Colorectal, NSCLC and SCLC, and Systemic B-cell lymphoma.
We supported a phase III trial of a treatment for Familial Adenomatous Polyposis (FAP), carried out across 21 sites. The client commented: “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 dermatology experience includes atopic dermatitis, T-cell lymphoma and Psoriasis. Our work in early phase dermatology means that we can help startups move forward, leading them through the complex clinical trial process. With one client, we worked on multiple phase I and II trials. They commented: “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.”
At Siron Clinical, we’re proud of our expertise in tackling complex clinical trials. Find out more. https://sironclinical.com/expertise/