SiteDocs Portal has transformed clinical research document and payment management, revolutionising the way documents are collaborated between the Biopharmaceutical Industry, Sites and other Collaborators.
Transforming the efficiency of document and payment management processes for clinical research, enabling Sites and Industry partners to spend more time on other valuable activities required to bring safe and effective products to market.
SOLUTIONS
Providing Products and Services to our clients to transform their organisational efficiency and growth.
TRIAL SITES
Implementation of Products and Services to our Site clients to transform their organisational efficiency and growth.
BIOPHARMA
Implementation of Products and Services to our BioPharma clients and also their Sites to transform their organisational efficiency.
SiteDocs Portal has transformed clinical research document and payment management, revolutionising the way documents are collaborated between the Biopharmaceutical Industry, Sites and other Collaborators.
Transforming the efficiency of document and payment management processes for clinical research, enabling Sites and Industry partners to spend more time on other valuable activities required to bring safe and effective products to market.
Electronic Investigator Site Files
The Investigator Site File (ISF) (Regulatory Binders) is managed within SiteDocs Portal intelligently, so that file management is never repeated. An example of this is that any content that is applicable to many projects (e. g CVs, GCP Certificates, Laboratory reference ranges or temperature logs) is managed once and kept up to date in the CoreDocuments. In the project specific module (Collaboration), smarts have been built in to prevent the repetition of common project documents.
We have been intentional with the SiteDocs eISF to ensure you are not simply converting a paper-based system to a digital filing system.
Electronic Trial Master Files
eTMF is managed by a Sponsor or by the Collaborative Group leading the project. While we have the DIA Trial Master File Reference Model designed into SiteDocs, Sponsors and CROs and IIT project managers have flexibility to use their own Table of Content Index.
The eTMF can also be linked to the eISFs for each of the Clinical Trials Sites and pushed out to those Sites using the TelePort feature.
Smart management of the eTMF using SiteDocs reduces time on file management and vastly improves file quality.
Electronic Signature and Delegation Log
The many nuances of the Signature and Delegation Log are built into the SiteDocs Informed Module, to support sites with efficient and quality management of their Project Delegation Logs in an electronic manner.
TrialDocs support organisations and site with an Electronic Signature Policy template that is then customised to include local needs. TrialDocs has a customised process to simplify the onboarding of new Sites and organisations to using the SiteDocs electronic Delegation Log.
Investigator Payments and processing
SiteDocs Pay has transformed the Investigator Payment process at Sites, ensuring all line items of a Clinical Trials Agreement is fully tracked and claimed from Sponsor, whether invoicing is completed within SiteDocs Pay or the clients finance system. Investigator Payments can be complex and time consuming for Site manages to account for, so the simple and complete mechanisms is welcomed by clients using the SiteDocs Pay system.
TrialDocs RemoteHub Service is also available to all Sites for the management and processing of their payments. Reach out to discuss how we can cleave this time-consuming task from your growing list of responsibilities.
Clinical Trials Tracking Database
Paramount to management and reporting for clinical trials, is a core database for capturing regulated data sets as well as any customisable data categories and fields required by a local client. This is the purpose of the Showcase Module, to track any category and data cluster that must be collected or that is desirable for upline reporting.
Remote Monitoring
We are proud to be supporting clinical trial continuity by enabling Remote Monitoring in a secure and private manner, providing Monitors access to eSource and document exchange, where the data is encrypted (in transit and at rest) and accessed only through multi-factor authentication.
Further information about this and the data sovereignty aspects is readily available.
Multiple daily training sessions are available for Site Staff and Monitors.
SiteDocs Portal
Multiple Service Tiers are available:
Introduction
Service
Core Documents Module is accessible to all Internal and External Users of a given Portal, therefore removing a common cause of repetitive work in clinical trials.
Essential collaboration module also enables Sites to manage a basic site structure.
Extended Collaboration
Service
Account holders have additional access to electronic Trial Master File, electronic Site Files, workflow management for document receipt and training.
Also included is management capability of electronic Site Signature and Delegation Logs, PDF redacting, and eISF/eTMF PDF-A conversion for long term Archive.
Clinical Trials Contract Compliance Service
All benefits of Tier 2, in addition to Site Payment management to ensuring 100% compliance to the clinical trial contract budget, and invoicing with Sponsors.
Executive Site
All benefits of Tier 3, including a co-management service for document management and Site Payments.
SIP Integration
We have collaborated closely with Cognizant to support all Sponsors and CROs that have chosen the Shared Investigator Platform (SIP) for their Site Interface.
Convenience and efficiency for Sites.
Convenience and efficiency for Sponsors and CROs.
Site Payments
There are several reasons why up to 30% of Site Payments are never invoiced to the Sponsor throughout the course of a trial.
Site teams and supporting Monitors are often time-poor and while elements of the Site Payments are eagerly tracked and followed up to manage risk, other aspects hang in the balance of experience and time-management.
Sponsors and Sites are time-leveraged with TrialDocs’ Services, supporting with payment set up, tracking and processing capability.
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