MedSurv

MedSurv-Portal is an online EDC system (eCRF/ ePRO) developed by MedSurv GmbH. According to the vendor, this validated system is designed to capture data in various types of studies, including clinical studies, non-interventional studies (NIS), patient registries, post-marketing observational studies, and PMCF studies. The modular nature of the system allows for customization to meet study-specific requirements. MedSurv offers support throughout the entire project workflow, from eCRF planning to validation and data capture.

Key Features

eCRF / ePRO: According to the vendor, MedSurv-Portal is a validated online EDC system (eCRF/ ePRO) that can be used in clinical studies, non-interventional studies (NIS), patient registries, post-marketing observational studies, and PMCF studies. The system is modular and can be customized to meet specific study requirements. MedSurv provides support throughout the project workflow, including eCRF planning, validation, and data capture.

Strong project management: MedSurv offers project management services to ensure efficient study execution. The vendor claims to provide fast response times and direct support to customers. Their project management approach focuses on sustainability and continuous improvement. MedSurv's certified management system aims to deliver high-quality service.

Compliance: MedSurv-Portal is designed to comply with various industry guidelines and regulations, including CDISC, US FDA 21 CFR Part 11, EU GxP Annex 11, FDA Industry Guidelines, GAMP 5, and ICH-GCP Guidelines. The system includes features to track changes with an audit trail and supports (S)AE management. It also facilitates monitoring activities, such as virtual data checks, real-time patient and visit status tracking, and study center management.

Data Management: MedSurv-Portal offers robust data management capabilities, including additional validation processes according to DVP (Data Validation Plan). The system allows for direct communication and query management within the portal. Document upload functionality enables the uploading of documents with patient allocation.

ePRO/ eDiary: According to the vendor, MedSurv-Portal supports the direct collection of questionnaires (QoL) and patient diaries. It provides an electronic platform for patients to complete questionnaires and diaries, eliminating the need for paper-based methods and potentially improving data collection efficiency and accuracy.

Clinical Trial Management: MedSurv-Portal provides daily updates of study data, aiming to ensure transparency and real-time access to study information. It offers features for remuneration and recruitment status tracking. The system aims to support the management of clinical trials, facilitating efficient study coordination and execution.