Smooth Drug Development provides regulatory support services in clinical trials.
Regulatory support is a complex process which ensures that parameters of clinical development process meet its main goal – obtaining of a marketing authorization.
Main steps of the regulatory support:
- Obtaining of a clinical trial regulatory approval
- Acceptance of the study results to go to the next phase of development
- Acceptance of the clinical program results for marketing authorization
There are two major regulatory risks:
- Refusal to grant permission to conduct a clinical trial (wrong choice of study design, patient population, endpoints, a reference drug, statistical methods of sample size calculation and evaluation of results, a risk-benefit ratio, a lack of data collected in preclinical or in previous clinical studies)
- Refusal to grant marketing authorization based on results of successfully conducted registration study (wrong phases of clinical development, wrong choice of study type for the purposes of registration, lack of reported data, incorrect methodology of the study)
To avoid the above risks it is necessary to evaluate the entire clinical development program. We collaborate with professionals from various scientific fields to comprehensively predict possible outcomes of clinical research and achieve expected results. If necessary we make requests to the regulatory authorities to obtain scientific advice.
We provide the following regulatory support services:
- Design of clinical development program and registration strategy
- Development of clinical research documents
- Amendment of documents before a clinical trial application to the Regulatory authorities
- Consulting with Regulatory experts
- Clinical trial application to the Regulatory authorities
- Ongoing submission to the Regulatory authorities
- Final report submission to the Regulatory authorities
We also provide services of drug registration dossier preparation and submission for a marketing authorization.
Smooth Drug Development is one of the leading contract research organizations in Russia, Baltic States and CIS, provides regulatory support services since 2011.