Choosing your EDC Solutions Provider
EDC systems are the industry standard for accurate, cost-effective, and safe collection of data. However, insufficient expertise in designing data validation plans, miscommunication between sponsors and EDC vendors about the former’s expectations and the latter’s capacities, poorly defined metrics, and delays in data entry and query resolution can all be major obstacles for the successful utilization of EDC. In order to provide a seamless service and ensure high-quality of EDC services, ClinSearch has developed this expertise in-house. Our data management department has accumulated expert knowledge in designing and setting up EDC systems for your clinical, post-marketing, and compassionate-use studies. We can assist you in preparing data validation plans, training EDC users, developing the optimal visual implementation solutions for your studies, and customizing data reports. During the whole process, the expertise of our team will be at your disposal! The process of setting up EDC starts with setting up objectives for the system by the sponsor or with the help of ClinSearch. This is followed by defining the regulatory compliance for the EDC, as well as the users, interfaces, and target processes. Then the rules and requirements are defined, the relevant processes, support functions, and data protection and data repository policies. Due to our expertise, we have the opportunity to be quick and efficient in proposing the best designs for your needs, accounting for risks for the functionality of the EDC and the quality of the data. Our EDC solutions offer the following features:
Customization of electronic case report forms(eCRFs);
Provision of a web-based platform, providing sites with access to data entry, thus managing a cleaning and locking process on-the-go, in which any queries against the data are resolved;
Adaptation of the final data to SAS dataset.
We also have an integrated statistics and medical writing department, as well as pharmacovigilance and materiovigilance experts, who can fulfill the safety design and monitoring needs for your projects. Our safety team is working on projects with encoding and review of terms, reported in clinical trials, medical history, prior or concomitant treatments; as well as identification of missing and discrepant data between SAE reports and clinical databases. We use the industry-accepted dictionaries MedDRA and WHOdrug and we have a full-time MedDRA-certified staff member, Mme Marianne Morineau, MD. Furthermore, MedDRA coding is integrated into our EDC solutions, so physicians have the opportunity to code immediately. If you are looking to start a study soon and want to explore the benefits of an EDC platform or need some ad-hoc medical writing or statistics services, do not hesitate to contact us. We will also be attending the EuroPCR in Paris, so we would be happy to schedule a meeting.

















