Accreditation Achieved on Medidata Rave Safety Gateway
We are pleased to announce our latest accreditation, which is to customize and support the Medidata Rave® Safety Gateway.
The Rave Safety Gateway is a configurable EDC-to-safety system interface that enables safety and data managers to collect and transmit safety data from investigational sites to a safety system, efficiently and accurately.
Timely reporting of serious adverse events (SAEs) in clinical trials is critical to sponsors and contract research organizations for both pre-marketing and post-marketing studies in the US. New European regulatory requirements for post-marketing expedited reporting are making the timely reporting of non-serious adverse events (AEs) a priority. Paper-based systems to collect AE and SAE data from investigational sites are inefficient, require manual re-entry of data into safety reporting systems, and are prone to errors.
The Rave Safety Gateway provides an efficient tool to collect AE and SAE data with E2B transmission capabilities to the Medidata Rave EDC platform. The Rave Safety Gateway leverages Rave’s flexibility and ability to manage large amounts of data to improve the accuracy and speed that safety data is collected and transferred to safety systems.
eClinical Solutions is an Accredited Services partner with Medidata. We have worked with Medidata since 2008 and are an Accredited Services partner on three key Medidata platforms including Rave, Medidata Coder, and Rave Safety Gateway. We work closely with clients to implement and utilize these industry leading technologies to meet their development objectives.
Our experienced data management professionals help life sciences companies easily interact with and utilize their clinical data. Our developers and data managers have experience with more than 200 studies that have utilized Rave for clinical data acquisition. We are uniquely positioned to help emerging biotech and pharmaceutical companies achieve their development objectives.
Please join the conversation! How are you collecting AE and SAE data in your clinical trials? What hurdles do you encounter? Have you implemented an electronic system to help collect and report safety data? If not, what hurdles are keeping you from doing this?
- On the Horizon: Discussing Key Life Sciences Trends for 2015
- Mid Size Pharma Implements elluminate® for Standardization and Analysis Needs