eSolutions

Clinical research has reached the electronic age. With our validated eSolutions, we can supply you with reliable and easy to use software to enhance your digital processes and receive customized reports by various interfaces, backed up by State-of-the-art internet security concepts.

Advantages of eSolutions:

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

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

Flexible and efficient coordination of all EDC activities through In-House eCRF design and management at FGK – you just need to press the button and access whatever data you need

The advantages are:

• State-of-the-art validated software and security technology in terms of access control, data archiving and availability
• Real time access to safety data – any time and anywhere enabling e.g. real-time decision support in DSMBs
• Visualization of actual status on data quality (missing data, queries, SDV status etc.)
• Increased quality: Using automatic edit checks of an EDC system does significantly reduce the error rate in data entry
• Increasing compliance: Easy-to-implement and use at study sites, no need to install special software or maintain a local data base, low demand for computer related skills by study personal
• Time savings: Early identification of discrepancies or data entry errors by remote monitoring, often minimizing the time spent by monitors at sites.
• Cost savings: The cost of the clinical trial can be reduced thanks to remote monitoring, less frequent site visits, elimination of printing costs, faster data entry, and lower data cleaning costs.

Patients can access a web application developed and designed to enable easy collection of data commonly known as “Patient Diaries” and “electronic Clinical Outcome Assessment” (eCOA) via their phones, tablets or computers while avoiding any synchronization problems due to separate eCRF and ePRO solutions. The data is stored directly in the eCRF where the investigator can examine it without the necessity of having to use different systems. The study participant is supported with advanced features designed to make their life easy – event scheduling that supports both planned and unplanned questionnaires, a messaging system connecting the patient to their physician, multilingual support and reminders via SMS and/or e-mail. Any text in the application is presented always in the respective native language.

Randomization, clinical supply management and investigational product assignments at a new level help to overcome any logistic challenges your trial design might have.
RTSM enables you to make continuous, real-time adjustments to match and keep up with unexpected changes to the study design.
Automated monitoring of stocks and triggering of orders in case of need ensure sites always have sufficient supplies on hand for their study participants.

Our electronic TMF is maintained by trained FGK staff throughout your study.

The advantages are:

• Realtime access to all documents for authorized personnel 
• Designed to upload/create, exchange, and update all trial documents within one secure, cloud-based application, version-controlled, as well as securely associated with comments, and tracked throughout the document life cycle
• Quality check of uploaded documents by FGK
• Based on the 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)

Our Clinical Trial Management System platform (CTMS) combines different modules to simplify the day-to-day business of your clinical trial which can have a positive impact on study timelines

The advantages are:

• Automatic workflows make your routine Management of all CRA activities more efficient:
  Schedule visits, generate reports, track protocol deviations etc.
• All information on study participants in one place: Enrolment, visits, screening failures and subject and study specific invoice tracking
• Site information in a clear organized manner, incl. submission status