eSolutions

Clinical research has finally reached the electronic age. Not only are all major regulatory agencies moving in the direction of electronic-only submissions, but investigation sites all over the world are now connected up via the internet. Moreover, a growing number of 'virtual' sponsor companies and parallel global operators have created new demands in terms of the automation and standardization of many tasks involved in clinical trials.

With our eSolutions, we are proud to respond to this growing need for online applications which are imaginative and advanced yet robust and validated.

Advantages of eSolutions:

• Reduction of handling and printing of paper
• Ability to view current data at any place and at any time
• Facilitation of the automatic transfer of data
• Reduction in management and archiving costs
• Greater transparency of and improved access to information for evaluation purposes
• Management of complex lifecycles and processes
• Reduction of errors and inconsistencies   

eCRF: flexible access to your study protocol

Our eSolutions offer electronic data capture, electronic study management and study portal functionality in a modular fashion.

The advantages are:

• Enables study data to be acquired, retrieved and analysed at any time and anywhere
• Carefully designed and intelligent query management
• Online analysis and reporting for real-time decision support in DSMBs and for monitoring innovative study designs
• Context sensitive help pages, helpdesk support and online access to relevant study documents
• Easy-to-implement at study sites: no need to install special software or to maintain a local data base
• State-of-the-art security technology in terms of access control, data archiving and availability
• Low demand for computer related skills by study personal
• Designed to optimize and to extend best practices

eTMF: facilitates your oversight of all study documents

According to the recent GCP revision we have implemented an electronic TMF which is maintained by trained FGK staff throughout your study.

The advantages are:

• Real time access to all documents for authorized personnel 
• Designed to upload/create, exchange, and update all trial documents within one secure, cloud-based application.
• Quality check of uploaded documents by FGK
• Based on the (DIA) TMF Reference Model and 21 CRFR part 11 compliant
• Study specific eTMF plan defining certain rules is created together with you
• Audit ready export (Consistent naming conventions, source format and PDF renditions, audit trails and metadata)

EMT: how electronic trial management maximizes your efficiency

Our eSolutions offer electronic data capture, electronic study management and study portal functionality in a modular fashion.

The advantages are:

• Access to trial information and processes anytime, anywhere
• Actual recruitment status with easy-to-use drill down through study sites and time frames
• Automatic status reports with build-in completeness checks and planned/actual benchmarks
• Workfloworiented and country specific management of regulatory processes (submissions, IRB approvals, signature sheets, etc.)
• Comprehensive representation of monitoring activities including scheduled and past visits, electronic monitoring reports, remote contacts and statistics about planned actually performed and remaining visits
• Management of all kind of different organisations and staff members (Sponsor, CRO, Sites, Insurances, Central Labs, Local Authorities, etc.)
• Document archiving, versioning and tracking system

Safety Control Center: More time for interpreting analysis results

Have you ever thought about the amount of time spent on preparing and reviewing paper printouts in order to evaluate the safety profile of a drug or a device? Can your DSMB members, safety officers or medical monitors focus their attention entirely on interpreting and understanding analysis results, or are they tangled up in the analysis of data structures? The fully web based Safety Control Center consists of a tool box of graphical, tabular and analytical displays which are individually designed to explore safety data and identify potential hazards or benefits relevant to your clinical development process.

The advantages are:

• Single trials, multiple parallel trials or pooled studies supported
• Real-time, batched or retrospective data import
• Work with adverse events, lab data and vital sign results
• Study designs and blinding aspects supported
• Extensive library of interactive graphical and tabular displays for longitudinal data (box plots, bar charts, line plots, scatter plots, shift graphs)
• Graphical patient profiler
• TreeMaps for structured adverse events data
• Data browser and data dictionary
• Team features for notifying, bookmarking and annotation sharing
• Private workspaces for document exchange
• Tailor-made solutions for small-sized or specific requirements available

IWRS: Your engine for more detailed informations

The IWRS (Interactive Web Response System) is available as a stand-alone service or integrated with eCRF and EMT tools. It is a sophisticated interactive web interface for patient randomization, drug supply management and real-time study status tracking.

• Supports complex, dynamic and multi-factor stratified randomization schemes
• Adaptive designs and outcome driven dose allocation
• Study blinding and emergency central code break
• Tracking of site management activities, such as initiation, activation, deactivation
• Drug assignment and drug distribution tracking
• Expedient management of the drug supply chain
• Real-time graphics data display, messaging and export tools
• Role-based user and access control management
• Low-cost due to provision as hosted service and much more cost-efficient than IVRS