Trial Management Services
With more than a decade of experience, the Acceliant services team is ready to meet all your EDC needs to successfully deploy, operate, and close studies. The team understands the start to finish clinical process and offers in-depth services to support every clients' needs. Clients can be deeply involved in the EDC creation and execution process or allow the Acceliant team to manage all aspects of the EDC system. The team offers the following EDC services:
- Project Management. Project management teams comprise individuals with industry experience, project management certifications, and information technology. A project manager is assigned to your team and will work with your team to design, deploy the study, and manage your study until it closes.
- eCRF Design Services. For sponsors who are not experienced in the design of eCRFs or need assistance in either small or large areas of eCRF development, the Acceliant eClinical Suite team brings years of experience to the table and assists in creating the best possible eCRFs for a study need. Using a powerful set of data collection elements the team understands which type of element should be utilized to ensure the best possible data with the fewest costly queries.
- Clinical Data Management. If a sponsor does not have sufficient resources to deal with the complete data management implementation of a study, the Acceliant management team can assign the necessary resources to get the job done utilizing onshore, offshore or contractor models as necessary or as determined by sponsor preference.
- Testing and Validation. The Acceliant eClinical Suite team understands that validation is a serious and critical portion of any study deployment. Depending on sponsor requirements the team can facilitate, assist or complete necessary validation practices within a sponsors computers system validation practices or, if none are available, can utilize stringent ISO and Clinical processes to ensure any EDC system is validated in accordance with necessary regulatory guidelines.
- Quality Assurance. The Acceliant eClinical Suite Team has a complete quality management system (QMS) in place to ensure the release of a high-quality, validated product. The QMS oversees daily research & development tasks and handles project development and hosting. All environments are validated, managed, and audited based on standard operating procedures to ensure ongoing compliance and deployed within the guidelines of our ISO certified locations.