Navigation Links
I-Tech Project Will Turn Out in Lower Costs for the Clinical Research Arena
Date:10/25/2013

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 http://www.prweb.com/releases/2013/10/prweb11159460.htm.


'/>"/>
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. MyTownInsurance.com 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:
*Name:
*Comment:
*Email:
(Date:2/18/2017)... ... February 18, 2017 , ... ProParagraph Fashion Volume ... Studios ’ ProParagraph Fashion Volume 2 for all multi-line FCPX project needs. ... can pick and choose from hand-crafted trend-setting designs with smooth animations that will ...
(Date:2/17/2017)... TN (PRWEB) , ... February 17, 2017 , ... ... mobility has not kept pace. Enovate Medical has introduced an innovative workstation designed ... years of supporting nurses, the Encore Mobile EHR Workstation offers a lightweight, highly ...
(Date:2/17/2017)... , ... February 17, 2017 , ... ... brings its educational assistance management solution to the exhibit floor for the ... Orlando, Fla. , From Feb. 19–23, 2017, more than 40,000 healthcare industry ...
(Date:2/17/2017)... ... February 17, 2017 , ... Corrective ... Warning Letter, **An FDAnews Webinar**, Feb. 23, 2017 — 1:30 p.m. – 3:00 ... corrective action (CA) and preventive action (PA)? , The methods share techniques and ...
(Date:2/17/2017)... ... February 17, 2017 , ... ... season , Trinity Health and the U.S. Soccer Foundation announced today that they ... underserved communities. Soccer for Success, the Foundation’s soccer mentoring program, teaches kids the ...
Breaking Medicine News(10 mins):
(Date:2/17/2017)... Theravance Biopharma, Inc. (NASDAQ: ... announced the presentation of positive clinical data for ... kinase (JAK) inhibitor designed to be intestinally restricted, ... European Crohn,s and Colitis Organization (ECCO). In a ... its completed Phase 1 study of single-ascending and ...
(Date:2/17/2017)... , Feb. 17, 2017   Risperdal lawsuits ... effects allegedly associated with use of the atypical antipsychotic ... Philadelphia Court of Common Pleas, where the ... tort program. According to a notice posted on the ... convene a meeting on March 9, 2017 at 11:00 ...
(Date:2/17/2017)... , Feb. 17, 2017  BioDigital, Inc., ... the partnership of their 3D body mapping technology ... IT.  The new integration will be used to ... interactive model of the human body. BioDigital pilots ... clinicians time, while also increasing the precision of ...
Breaking Medicine Technology: