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.
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, as we conduct risk-mitigated studies and obtain valuable outcomes on time and within budget.
With our flexible and tailor-made approach, we support our clients exactly when and where needed, either by providing a full-service solution or stand-alone services:
Specialized in complex fields:
Early phase oncology trials often recruit heavily pre-treated patients with advanced disease. In contrast to late phase trials, detailed data are collected in a limited number of expert centers, and oncology know-how is key to succesfully design the study and write a clinically valuable and operational feasible protcol, as well as execute the trial. Due to their complex nature, our early phase clinical projects are monitored intensively by our oncology CRAs and managed by exception by our project managers.
SMS-oncology is specialized in early phase oncology trials, comprising the majority of our work. Many of these phase I/II trials involved first-in-human, followed a dose-escalation study design, and/or involved other multifaceted procedures. In addition to hands-on study conduct expertise, the majority of our consultancy projects involved advice on how to best move towards clinic including tangible study designs.
SMS-oncology works extensively within the immuno-oncology field including cutting-edge innovative cancer treatments. We have up-to-date experience in running immuno-oncology trials, in-depth knowledge of the different types of immuno-oncology drugs (e.g. vaccines, immune stimulating peptides, checkpoint inhibitors) and conduct these trials to meet very specific needs such as immune-related response criteria (irRC and iRECIST), immune related adverse events (irAEs), and leukapheresis. SMS-oncology has relevant experience in working with several Advanced Therapy Medicinal Products (ATMPs)
Our strong operational experience is further underlined by our consultancy services, as we have provided expert drug development advice, prepared numerous clinical development plans, and organized and chaired several scientific advisory boards in numerous consultancy projects in immuno-oncology. This included a wide variety of drug modalities in both the solid tumors and hematological setting.
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 has relevant experience in conducting several multi-center international pediatric oncology studies throughout Europe.
RFP or protocol advice?
Would you like to request a proposal (RFP), or interested in getting a free and confidential review of your planned early phase oncology trial (draft) protocol? Use the forms below: