Navigation Links
I-Tech Project Will Turn Out in Lower Costs for the Clinical Research Arena

Wilmington, DE (PRWEB) October 25, 2013

Led by its Directors, Carlos Caceres Valdebenito, M.A. and Gerardo M. Uviedo, M.D., such project is focused on the establishment of a virtual platform for ethic committees (EC), in order to digitalize the full regulatory process including, but not limited to, protocol/ICF submission, protocol/ICF assessment and follow up. The registered member will be able to keep a close “on line” view of said process and to interact with the ethic committee authorities thanks to the required encrypted safe and QA validated system, which will doubtless ensure a better, faster and safer way to interact with the EC Authorities, besides reaching protocol approval.

To contribute with the massive implementation of said system, which will take time, it is crucial to get through the process of standardizing its uses and adding as many ethic committees as possible to make this novel tool work. However, this effort will contribute to make clinical trial regulatory process faster and to lower industry budgets impacting afterwards on an easier set up for medical products (pharmaceutical and medical devices) in the market in a shorter timeframe.

“At this moment the mentioned project is at its design stage and it is expected to be ready to start working by the end of 2013 on its BETA phase upon some EC registration from USA, EU, Asia and Latin America”, says Carlos Cáceres.

The necessary investment to finalize the project was not a problem, since some financial cooperation was received from enterprises interested in getting good results, lowering time and costs in their projects. Nevertheless, Clinical Trial Foundation (CTF) is open to register new participants in its Sponsored Program. CTF has named Dr. Gerardo Uviedo as Sponsored Program Director for this institution.

Next step is to harmonize the variety of working styles and regional particularities and normative with the system in order to allow CROs, investigational sites and PIs gain access to every steps of the regulatory process and document assessment follow up by IEC.

Through this, the most challenging activity in clinical trials will be sorted thanks to a unique dynamic, on line, follow up system, where any inquire or question, can duly be solved giving back the necessary feedback to complete all the requirements in a reliable, faster and efficient way.

Clinical Trial Foundation is also thinking of expanding this novel system to other Clinical Trial steps with a service pack of the same scheme.

“Time is already important and is coming to be called the golden key in clinical trials, it is necessary to work fast and safely, with dependable methods, but all of us know how hard the impact is on the final budget in this field…” said Dr. Uviedo.

We invite every IEC, CRO, Clinical Trial Institutions and Investigational Sites to consider their registration in this service, not only to test what could be a very helpful tool to shorten regulatory timeframes, but also to get into the feeling of accompanying the document assessment live and interacting directly in between with the main decision making persons.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. Hi-Tech Advances May Improve Diabetics Lives
2. How the brains daily clock controls mood: A new project
3. Image share project gives patients and physicians anytime, anywhere access to medical images
4. Optogenetics project takes top NIDA Addiction Science Award
5. Leah Hoskins, F.I.L.M. Project Founder, Headed to Jail?
6. The W3 Project Receives Support from Doulton for Emergency Relief Efforts
7. Gene sequencing project identifies potential drug targets in common childhood brain tumor
8. Stanford Woods Institute for the Environment announces 2012 Environmental Venture Project awards
9. Reveals How Project CAP and Insurance Agoragate will Take Away Market Share from the Captive Insurance Carriers and give it back to the Independents
10. JHU Bioethics Institute receives PCORI pilot project award
11. UCLA-led project aimed at African American couples affected by HIV gets $2.5 million boost
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug rehabilitation ... new cutting edge recovery program that has been 50 years in the making. ... with the purpose to free addicts from the symptoms and negative behaviors of addiction. ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for ... aware of the benefits of Botox® in the treatment of moderate facial wrinkling, few ... and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted by an ... IL, UV Angel is evaluating the efficacy of its product and its disinfection protocol. ... 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical ...
(Date:11/25/2015)... Spring, Md (PRWEB) , ... November 25, 2015 ... ... Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible ... history of this disease. The Periwinkle Pioneers, nominated by the public, will receive ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
(Date:11/25/2015)...  Today AVACEN Medical announced the issue of United States patent No. ... ". This patent shields the company,s AVACEN 100 dry heat therapy medical device and specific methods ... Photo - ... ... ...
(Date:11/25/2015)... , Nov. 25, 2015 USP 800 ... drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, ... technicians). The chapter also covers all entities which ... pharmacies, hospitals, other healthcare institutions, patient treatment clinics, ... --> --> What is ...
Breaking Medicine Technology: