Management Systems

SimpleTrials

SimpleTrials improves planning, execution and tracking of clinical trials. It enables tracking site start-up activities, study milestones, managing electronic visit reports across the studies and overseeing monitoring plan adherence. You can always assess study recruitment efforts against targets, trend screen failures and protocol deviations, and track subject details by a visit and even integrate the system with EDC application.  It manages a comprehensive contact database of sites, sponsors, teams, vendors and enables management of investigator contract templates by country, currency and fee types. Furthermore, a CFR Part 11 compliant electronic Trial Master File (eTMF) utilizing the DIA TMF Reference Model and including document tracking and export features are a part of the system. 

B on Track

All tasks regardless the complexity, length or process are managed in a Biomapas self-developed task management tool B on Track. The tool allows us to see all upcoming/ongoing/overdue tasks in real-time and to track their completion status, quality of delivery and draw reports to allow management oversight and ease decision-making process.

Compliance Wire

ComplianceWire is a software tool used to assign, deliver, documenttrack and report trainings. It is the best-in-class web-based platform designed specifically for highly regulated industries. It is designed to effectively and efficiently automate the creation, delivery, and reporting of role-based training, qualification and compliance programs. 

eCTD Office

An off-the-shelf suite of integrated eCTD, NeeSVNeeS software products for the creation, validation, publishing, viewing and manipulation of regulatory documentation for electronic submissions by pharmaceutical companies to Competent Authorities. 

Clinical Operations

Regulatory Affairs

Pharmacovigilance