The development of anticancer drugs in the highly competitive and rapidly growing oncology landscape is more difficult and has a lower success rate than in other indications. In-depth oncology expertise and hands-on experience in the field are key to meeting needs or challenges and seizing opportunities that arise before or during study conduct. With this know-how, we can conduct risk-mitigated studies and obtain valuable outcomes on time and within budget.
That is why SMS-oncology takes pride in being a full-service CRO dedicated to clinical oncology and hemato-oncology studies. With our unique business model integrating consultancy and clinical operations, we cover the whole value chain from clinical study design, through to setup, management and completion of your Phase I to IV oncology trials. Providing proactive guidance benefits our clients as it helps improve quality, increase speed and reduce costs.
Our expertise is further strengthened by our flexible and tailor-made approach to the specific needs of every project. We are appreciated for supporting our clients exactly when and where needed, either by providing a full-service solution or stand-alone services. Our clients include emerging small and mid-size biotech companies, large pharmaceutical corporations as well as individual investigators and research groups.
Specialized in complex fields:
Early phase oncology trials - While early phase clinical trials in other therapeutic areas involve healthy volunteers, those in oncology trials often recruit heavily pretreated patients with advanced disease. Due to their complex nature, our early phase clinical projects are monitored intensively by our dedicated team of clinical research associates (CRAs) and closely supervised by our experienced project managers.
Immuno-oncology trials - SMS-oncology works with cutting-edge innovative cancer treatments, including immunotherapy. We have up-to-date experience in running immuno-oncology trials, in-depth knowledge of the different types of immuno-oncology drugs such as vaccines, immune stimulating peptides, checkpoint inhibitors among others, and can conduct these trials to meet very specific needs, e.g. immune-related response criteria (irRC), immune related adverse events (irAEs), and leukapheresis.
Pediatric oncology trials - Children are not just ‘small adults’. A company needs a pediatric investigation plan (PIP) in place when it submits a Marketing Authorization Application (MAA) in Europe for an adult drug, otherwise the MAA will be rejected automatically (unless the drug is exempt because of a deferral or waiver). The PIP is to be submitted to the European Medicines Agency's Pediatric Committee (PDCO) and should include a description of the timing and the measures proposed to demonstrate the quality, safety and efficacy of the oncology drug in the pediatric population (and its age subsets) compared to adults.
SMS-oncology can support with the succesful planning, setup and execution of early/late phase and post-marketing oncology trials by offering: