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Mail |
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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
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Online Support |
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A 24/7
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support team
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and medical
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Objectives |
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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 |
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idea was born aiming to accomplish the following objectives: .................. Read more |
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Quick Links |
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Overview |
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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. |
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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).
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Project Description |
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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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using the latest technologies that ...... Read more
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TPMC e-Clinical Trials Medical Centers |
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SAUDI ARABIA |
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Central Zone |
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Western Zone |
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Eastern Zone |
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OTHER
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TPMC e-Clinical Trials Login |
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Organization Structure |
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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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Currently Running Clinical Trials |
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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® ) |
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Ethical Considerations |
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Despite the fact that patients' names and identities are unidentified throughout all TPMC e-Clinical Trials research processes and all submitted data will remain encrypted from data entry to data analysis and publications; An ethics approval letter will be obtained from the ethics committee of each participated hospital. Additionally, a consent form is to be collected from each individual enrolled subject in any given clinical trial.
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