A large scale prospective, observational, open-label, multi-country, multi-center group of individually running phase-IV post marketing pharmacosurveillance clinical trials’ project.

This high-end FDA compliant medical I.T. system was developed using the latest technologies that were incorporated and integrated to produce an extremely secured multiple engines of remotely controlled medical data capture systems, follow-up, and real-time online reporting and analysis of quality e-medical applications and databases designed according to the strictest guidelines, rules and standards of ICH, GCP, FDA 21 CFR Part-11, and ISO27799.

TPMC e-clinical trials project is an unsurpassed medical I.T. project in terms of technology and security for both input and output modules. The system can be accessed on real-time basis for the whole authenticated active accounts in certain authorized participated clinics, polyclinics, hospitals, in both institution and private medical sectors in one city, group of cities, one region, group of regions, country, and all countries after it was started in the Kingdom of Saudi Arabia.

At investigators’ sites, TPMC e-clinical trials system will provide flexibility and rapid well-controlled data entry even when connectivity options are less than ideal. Fully automated edit checks, including sophisticated cross-form edits, help to clean all the data right at the point of entry.

As guidance to all investigators and improvement of their efficiency, the system was designed to be tutorial & presented in a way to provide easy and “simple to understand” interfaces.

Conforming to all 21 CFR 11 guidelines, a complete audit trail is kept of every form, including version changes, the time and date when users log in and log out, electronic signatures, and tracking records of all study related events starting from user logging & ending by data locking.

TPMC electronic clinical trials’ project is set to last 3 years for each and every studied pharmaceutical drug of multiple phases’ trials and different launch dates depending on participated countries / medical centers and their principal coordinating centers’ priorities and time frames.

These multicenter, prospective, observational, open label, cohort studies are conducted on both male and female subjects who are entitled to receive their disease related prescriptions from their accountable medical doctors according to each medicine original pamphlet guidelines with reference to their age groups, medical history and all other pre-prescription check-ups and well studied factors, taking into consideration other medicines / D-D interactions, precautions, pregnancy, allergies, and risk factors, providing the fact of having all subjects consented to be included. Otherwise, excluded.

TPMC e-clinical trials project is designed to be non experimental group of studies, where all enrolled patients should be treated according to the current concerned and applicable routine hospital practice and standards of care.

Project’s related databases/co-investigators firewalled private portals were developed with a user-friendly interfaces and control panels that made the access to all logistics' links easier and all in one place: like user details, incomplete records, final records, other users’ records, cross-checked records, under investigation records, under inspection records, fill new records, patient follow-ups, reporting system, general statistics, online analysis tables, graphs and system user statistics/surveillance.

Development and structural operational plans of TPMC e-clinical trials project were set with a non compromised components and functionalities that will fulfill all the requirements of a large scale number of coordinating centers to help in guiding and training sites’ investigators, managing subject eligibility, subject consent form entry, CRFs data entry, patient follow-ups, ADR and SAE reporting, subject data protection, data management, monitoring, audits and inspections, real time on-Line data reports and statistical analysis.

The whole project integrated software/components including the data management is developed as highly strict, well-controlled and secured electronic medical records and signatures in both procedural and administrative controls.

For databases` security reasons, hundreds of high-end sophisticated servers are under installation based on the calculation of 5 different servers for each studied medicine:

1- Internet server

2- Email server: where the authenticated users - only - can access their email facilities.

3- Application server: where the authenticated users - only - can access their firewalled private interfaces, and applications.

4- Database server-1: where the authenticated users - only - can save their incomplete records or submit their final records or follow-up records.

5- Database server-2: where a complete backup is taken from Database server-1 every 3 minutes + the authenticated users - only - can generate and read their reports and do their analysis.

In addition to a high priority switches and load balancers and many more…..etc….

Back and forth connections between users and servers are over 256 SSL bit encryption and stored backend data are encrypted with 4 layers of 4THD INC authenticated encryption keys that would never be violated or breeched.

Any backup process is designed to last not more than 4 seconds & if - for any reason – exceeded this limit, will shut down automatically to be repeated in the next batch to take place after 10 minutes.

Every 30 minutes a complete encrypted backup is transferred from the main – timely framed designated - running servers to other ones located among different Fourth Dimension e-medical services Canada - (4THD INC) - data centers located in different 28 countries.