Specialised Medical Services-oncology BV (SMS-oncology) is a full-service Clinical Research Organization (CRO) with an exclusive focus on clinical drug development studies in oncology and
hemato-oncology. We perform the complete spectrum of activities associated with clinical trials, from development of the clinical strategy plan to initiation, implementation and completion of
Phase I to IV oncology trials. More specifically, our work entails:
Clinical operations: including, feasibility studies, site and investigator selection, medical writing (e.g. clinical trial protocols and Investigator Brochures), regulatory submissions (e.g. Clinical Trial Applications, Orphan Drug Designation applications), site management and project management, site visits, pharmacovigilance and data management/ biometrics. Since SMS-oncology's inception in 2007, we have carried out more than 75 clinical projects covering all development phases. This also enabled us to developed a large network of key opinion leaders in oncology and clinical trials, within Europe and internationally.
Consultancy - Scientific Affairs: our drug development oncology experts, both non-clinicians and clinicians, work together with sponsor teams to review pre-clinical / non-clinical development data and plans, to draft the compound's clinical development plan, including defining tumour type selection and specific indication/ patient population as well as biomarker strategy, scheduling and combination therapy options, and also to generate a Target Product Profile. Furthermore, we have contributed and overseen the drafting of several Investigational Medicinal Product Dossiers (IMPD) and Investigational New Drug (IND) applications and been involved in related interactions (pre-submission meetings) with Competent / Regulatory Authorities (national and EMA/ FDA).