Tabuk Pharmaceuticals e-Clinical Trials Project
Overview
TPMC e-Clinical Trials "Tabuk Pharmaceuticals Multi-Country Multi-Center electronic clinical trials project" is an unprecedented initiative of conducting a large scale group of electronic - post marketing pharmacosurveillance - clinical trials.
This hi-tech project is designed and built according to the strictest rules and guidelines of ICH/GCP and electronically controlled according to the FDA 21 CFR Part-11 regulations as well as the ISO27799 best practices that will add artificial smart controls, management, high security, speed and quality to every part of all running clinical trials' processes.
TPMC e-clinical trials project is developed and operated by Fourth Dimension e-Medical services Canada, and is starting in Saudi Arabia and propagating to each and every country where Tabuk pharmaceuticals operate.
A wide range of pharmaceutical drugs will be studied individually throughout continued multiple phases of this project life cycle.
The aim of each individual study is to furthermore evaluate efficacy and safety of a given studied drug by itself as well as in relation to other prescribed medicines of the same indication (s).
Organization Structure
Several medical entities are integrated in TPMC e-clinical trials project and are represented by certain trial's designated principal coordinating centers, steering committees, participating hospitals, co-investigators, research assistants, and databases' coordinators.
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A 24/7 dedicated support team of administrators and medical DBMs are ready to assist you in all TPMC e-Clinical databases & application programs' related issues.
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Project Description
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 ...
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Currently Running Clinical Trials
Four major pharmacosurveillance post-marketing clinical trials are running in given individual phase and each country participating in TPMC e-Clinical Trials project . As a start, the following clinical trials are running in the kingdom of Saudi Arabia:
- Mycophenolate Mofetil Tablets 250 and 500mg: (MOFETAB®)
- Pregabalin Capsules 75, 150, and 300mg:(NERVAX®)
- Valsartan and Valsartan with Hydrochlorothiazide Tablets 40, 80, 160, and 320mg: (TABUVAN® and CO-TABUVAN®)
- Diclofenac Sodium 75mg dual release caps: (DIVIDO®)
TPMC e-Clinical Trials related communications are confined to it's secure mail server.
Participating centers' authorized co-investigators can access their emails by following this link
Our Objectives
For the reason most of the post marketing surveillance trials are lacking the means of mirroring the real world of the studied drugs with respect to safety and efficacy after marketing and dissemination to the general population and that is due to the inclusion of a limited number of patients while having a short periods of time studies, In addition to inadequate representation of the patient populations & the direct comparison with drugs in the same therapeutic class used for the same indication; TPMC e-clinical trials project
idea was born aiming to accomplish the following objectives:
.................. Read more
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