The platform’s open architecture and J2EE compliant data models allows devices such as PDAs, handheld and tablet PCs, remote monitors and other multi-media applications to be incorporated into any solution.
Plan the way development unfolds across studies and design an eCTD that meets submission requirements. Develop templates that address protocol requirements and rollout into lab tests and medical reports and compile eCRFs. Support the documentation of Clinical Study Reports outcomes compilation for multiple studies and sites to develop eCTD. The Genix iBPMS provides fully automated workflows, templates, performance monitoring and reporting.
Embed compliance with 21 CFR, Part 11, ICH and good clinical practice requirements into the development lifecycle, procedural routines and data capture templates. Record and maintain patient consent, ensure ethics requirements are managed, secure access to data with e-Signatures and alert key staff about adverse and serious adverts events. The X-id3 complies with FDA standards and provides a clear and reportable audit trail of activities, data and documents.
Govern research, set performance targets and review status at a granular level across sites. Review boards, ethics committees, internal and external auditors can access relevant, version controlled documents and data from one system which delivers compliant record management and date and time stamps all activities and data updates. Ensure patient consent and ongoing study reviews meet internal and regulatory requirements.
Electronic Data Capture
Design, review, approve and lock user-friendly templates and forms for ongoing or one-off data capture. Set data coding and formal structures to ensure compliance and monitor data accuracy, integrity and history through clear and reportable data and time stamps. Then report or compile populated templates into predefined master documents for electronic or hard distribution.
Trial Monitoring & Intelligence
Receive up-to-date reports into personalized dashboard to monitor study schedule, budgets, performance, results and major events. Analyse incoming data at object or site level or rollup to track studies and forecast.
Set schedules, budgets, protocols, standards and procedures at the study level and rollout to individual sites. Collect status and performance data across sites and rollup to analyse study progress for forecasting of total cost, estimated end dates.
Manage specimen collection, storage and distribution. Track specimen clones and locate individual samples for testing or sharing. Ensure specimen-banking activities remain private, have patient consent and internal approval. Initiate billing against specimen drawdown and manage inventory levels.
Ensure results data is scheduled to meet timing requirements and captured consistently and correctly to meet regulatory requirements. Send alerts to lab technicians to notify of pending tests. Link lab activities to doctors and specialists for results analysis with notes and related documents in any format to facilitate assessments. Send real-time reports of adverse and serious adverse events to all related staff and stakeholders.
Recruit, randomize and stratify patients ensuring security, privacy and consent. Manage in-patient and out-patient calendars and rollup to site and study schedules. Monitor late appointments and bottlenecks, redirecting work when necessary. Send automatic alerts of coming appointments to patients and related staff members and initiate required activities such as dose administration, samples and health reports. Show links to related notes and documents in any format to support clinical activities. Receive ePROs and link to patient devices.
Maintain recruitment databases and monitor investigator and staff training in study and site standards and procedures. Manage investigator calendars and appointments and track status of investigator schedules. Automatically trigger investigator payments and monitor total cost. Send alerts, notes and event reports to PDAs and remote monitoring devices to support investigators across sites.
Clinical Supply Management
Plan clinical requirements for drugs, devices, reagents, documents and equipment then manage the study-wide or site level supply chain from vendor acquisition through to consignment, billing and payments. Monitor supply standards against contracted parameters, maintain inventory levels and review storage locations.
Manage site acquisition, standards assessments and resource rollout within study parameters. Monitor status across the site to improve sponsor liaison and meet IRB requirements. Link alerts, notes and related documents in any format to support collaboration across radiology, chemistry, pharmacy and physicians.
Assign budgets and activity costs across one or many sites and manage to completion. Confirm activity status, calculate total billing and payments due, trigger external system processing and upload results to forecast and report.
Train site and study staff in relevant regulatory requirements, GLP, GCP and GMP standards. Publish study handbook and initiate web-based learning. Track completion of mandatory and optional training requirements and update relational databases. Trials have the options of integrating a full, online Learning Management System into their solutions.
The Project Manager links resource availability and costs to scheduling through the Workflow Module and ensures that standard reporting and data capture templates and forms are used across all similar and related projects.
It provides Project Managers with dashboard views of current status and embeds risk management matrices and weightings for use. It can be linked to the Supply Management Module to facilitate project related procurement and to the Financial Management Module to track actual payments and receipts. Projects are easily set-up using the drag-and-drop facility and linked to Program and Portfolio hierarchies improving integrated reporting and governance.
Program & Portfolio Management
The project management module can be integrated with more advanced Program Management capabilities if required. This would allow exceptions based reporting based upon more complex business rules and greater in-memory cache to accommodate the data analysis and increased volume required.
Predictive and simulation modelling can also be made available to support planning, forecasting and risk management to better drive portfolio level benefits achievement. Internally held algorithms that drive data aggregation requirements can be programmed into the modelling frameworks to expand management capabilities without relying upon program management training.