Efficient and effective investigator site and CRO collaboration and relationship management is a natural extension of the eTMF solution. As competition increases for the recruitment and retention for top performing sites, sponsors must invest in innovative processes and tools to be the Sponsor of Choice. eTMF is a critical starting point towards effective portal development and a key driver for the return of investments made in portal technologies. Effectively developed portals are key competitive advantages, and also deliver the ability to remove barriers which delay site activation, increase the speed of investigational product delivery, improve effective communication and drive the completion of studies through efficient collaboration and document/information exchange.
At Paragon Solutions, we have developed accelerators to support portal development:
- “Voice of the Investigator” focus group research, which provide extensive insights from your Investigator related to their priorities of collaboration and interaction
- Capabilities maturity models and “straw man” profiles, which provide a starting point for requirements analysis and business case development
- Representative ROI calculations and justifications, which support business case development
Trial Master File (TMF) Transformation
The Trial Master File (TMF)
is a GCP pharmaceutical
record that contains all the
essential documents relating to a clinical trial that are created
before the trial commences, during trial conduct and after
Structured Protocol Authoring for Clinical Trials
For pharmaceutical firms, the clinical protocol builds the foundation for every clinical
research study, creating potential impact on everything from the study design to
planning submissions. An error in the protocol affects downstream activities, causing
costly latencies, manual rework and inevitably protocol violations.
Clinical Optimization Practice Overview
Paragon’s Clinical Optimization Practice specializes in solutions
that help sponsors and CROs increase operational efficiency,
lower costs and manage risk.
Revenue Management in Life Sciences
With increasing consolidation,
globalization and regulation
in the life sciences industry,
managed care organizations have an even greater need to
successfully align business strategies, processes and systems
across the enterprise to remain competitive. Investing in a
revenue management solution that allows for integration of
customer, contract, product, marketing, financial, reporting and
Electronic Transfer Master Files (eTMF) Project Implementation
The client, still managing all their clinical trial documentation with paper
archives, received many violations due to the lack of well managed Transfer Master Files (TMF) processes and the inability to
produce requested clinical trial documents during inspections.
Electronic Records Auto Classification
A global pharmaceutical firm wanted to improve records retention and disposal compliance for current and future client record
collections in accordance with its Archiving and Records Management Policy and Retention Schedule.
Enterprise Content Management Implementation
A specialized global health company dedicated to enhancing life for consumers around the world, wanted to maximize the value
of its investment in Enterprise Document Management technologies.
Metrics Reporting Application
A global pharmaceutical company was experiencing difficulty reporting on key metrics within the manufacturing division.
Specifically, the client required a mechanism to report on complaints, actions tracking, audits, release process, and follow-up
within the Metrics Reporting Application.