There are numerous steps involved in the set up that will lay the ground for a well conducted study. Our longstanding experience in managing real-world investigations will allow you to rely on a robust service offer:
- Ethics Committee submissions
- If necessary, review of national regulations and legislations regarding ethical requirements
- Patient informed consent
- Regulatory document preparation and collection study sites recruitment for field studies
- Calculation of number of sites and patients per site
- Database selection and data governance for database studies
- Investigator agreements
Ethics Committee Submission
We ensure that our clients’ studies are conducted in accordance with the latest revision of the Declaration of Helsinki, the Guidelines for Good Epidemiology Practices, and local regulatory requirements. Additionally, we can provide guidance concerning the submission of study protocols to local and national ethics committee, and preparation of informed consent forms.
Regulatory Document Preparation and Collection
YOLARX can provide guidance and strategic consulting in regards to effective preparation and submission of regulatory document that are consistent with international regulations and that are tailored to specific-country requirements.
Field Studies: Study Sites Recruitment
In contrast to randomized clinical trials where investigators are selected based on the number of patients that can be recruited at their site, observational studies often require a representative sample of sites (i.e., not just the largest ones). Hence, protocols often include a description of the sampling strategy that will be used. Identifying and enrolling the sites then becomes challenging, especially when dealing with smaller institutions. When conducting field studies, YOLARX offers effective solutions concerning the optimization of patient recruitment that are specific to pharmacoepidemiologic studies. We also have an extensive network of collaborators across the globe that can advise you on the best patient recruitment strategies fitting your purpose and country specificities.
Database Studies: Database Selection and Data Governance
YOLARX provides guidance regarding data access policies of various databases. We can help you select the most appropriate databases that can address your research questions and provide the required data in the most cost-effective and timely manner, which will ensure successful study design and implementation.
Our extensive network of international collaborators enables timely access to various types of existing data sources such as administrative claims databases, electronic health records, etc. In addition, our experience in using and analyzing data from a variety of databases and, particularly our knowledge of linkage capabilities across data sources enables the conduct of studies requiring data from multiple care settings or various regions around the world.
To ensure successful study implementation, YOLARX can assist you with developing and managing necessary training to study and research staff including research nurses, study coordinators and clinical research associates.