"Phase-II to Phase-IV Clinical Trial Management & Technologies"
Trial Management
Prothix Lifesciences full-service clinical trials operations support our clients with study feasibility, pre-site qualification, initiation, patient recruitment services, site management services, and study monitoring (including Central Monitoring, Remote Monitoring & on-site monitoring) to ensure patient safety. Our well-trained and highly competent Project Managers, Senior Clinical Research Associates, Clinical Research Associates, and Clinical Trial Assistants have years of experience in various therapeutic areas and have worked with more than 650+ clinical investigators across a wide range of therapeutic areas including Oncology, Infectious Diseases, CNS, Dermatology, Respiratory, Endocrinology, Haematology, Immunology.
Trial Technologies
Leveraging Prothix's eClinical technologies such as Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Remote Source Data Verification (rSDV) to streamline and automate various aspects of trial management, enabling planning, execution and monitoring of clinical trials.
Clinical Trial Management System (CTMS)
CTMS enables Prothix to maintain a centralized, relevant, and up-to-date study and operational database; thus providing users with real-time operational visibility and total control. It allows you to map out the entire clinical trial lifecycle, right from recruiting to reporting, so that your research team can easily keep track of activities they need to perform.
Remote Source - Data Verification (rSDV)
Prothix has adopted an alternative remote monitoring approach. Prothix uses a well-designed 21 CFR Part 11, EU Annex 11, GDPR, and HIPAA compliant remote source data verification (rSDV) application. rSDV enables remote access to study documents over a secure portal.
Electronic Data Capture (EDC)
A digital platform and strategy to electronically capture, organize, share, and store all those essential documents, images, and artifacts that arise during the lifecycle of a regulated clinical trial.
