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Regulatory affairs

Starting a clinical trial involves notifying it to applicable competent authorities (CAs) and ethics committees (ECs) for their information and, in some case for explicit written approval. The more efficiently this start-up process is carried out, the sooner countries and sites can be activated and patients be enrolled. Being familiar with the different regulations, agencies, practices and procedures in different countries is a distinct advantage.

SMS-oncology’s experienced team of start-up specialists operates in close collaboration with our clinical operations, consultancy, medical affairs, pharmacovigilance and data management departments. This allows us to offer full regulatory affairs services, including:

  • Providing input into briefing packages and attending Scientific Advice meetings with the FDA and the EMA
  • Collecting and/or preparing essential documents in accordance with ICH-GCP and applicable local regulations
  • Designing and/or reviewing the study-specific master informed consent form (ICF) and country- & site specific ICFs
  • Notifying and submitting the CTA/IND file to the CAs and ECs in a timely manner, and collecting written approval documentation as appropriate
  • Notifying the CAs and ECs of any substantial and non-substantial amendments and product safety updates, wherever applicable
  • Supporting our clients in attempting to benefit from accelerated approval opportunities, e.g. obtaining Orphan Drug Designation (ODD) or “Priority Medicine” (PRIME)

Although the European Clinical Trial Directive No. 2001/20/EC (CTD)* was written in an attempt to standardize the way in which clinical trials are conducted and approved by CAs & ECs across the EU, there remains a lot of variability as each member state has interpreted the CTD slightly differently, hence the national legislations are all different. SMS-oncology can navigate this complex regulatory landscape and ensure the submission approval process runs efficiently.   


*Please note that a new Clinical Trials Regulation (CTR) EU No 536/2014 has been approved by all EU member states but is not yet applicable (expected by October 2018). Because it is a regulation rather than a directive, the legal text will be implemented exactly as written in all member states without having to be “translated” into national law. In practice, a single set of documents will be submitted via a single entry point (the EU portal), and single CA & EC approvals will be granted for all investigational sites in the EU at once.

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