Tools for Clinical Trials Professionals

Applied Clinical Trials;  June 1, 2007 ;   Anonymous;   483 words ...Common Framework and Organized eCTD Submissions Goal of New Software Product Octagon Research Solutions...contains relevant standards of practice for compliant eCTD submissions. The company's Regulatory Affairs, Regulatory Operations...

ISI Announces Regional eCTD Readiness Workshops for Electronic...

PR Newswire;  July 11, 2007 ;     452 words ......control recommendations. With more than 400 successful eCTD submissions to its name, ISI remains committed to passing on field...has delivered nearly 1,000 electronic submissions and 400 eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations...

ISI Announces eCTD Readiness Workshop Series.

PR Newswire;  May 1, 2007 ;     671 words ......control recommendations. With more than 350 successful eCTD submissions to its name, ISI remains committed to passing on field...delivered more than 600 electronic submissions and 350 eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations...

Take Solutions Offers eCTD Workshop

Wireless News;  August 1, 2008 ;     347 words ......the upcoming months. According to Take Solutions, this eCTD Submissions Workshop will discuss the current regulatory guidelines...Training Records Management, Structured Product Labeling and eCTD Publishing Solution Suite. Take Solutions is an international technology...

Open Text Announces Completion by Jazz Pharmaceuticals, Inc. of FDA...

PR Newswire;  November 26, 2007 ;     787 words ......submission process to certify the technology platform used for eCTD submissions. Like many pharmaceutical companies today, Jazz Pharmaceuticals...selected Open Text's Collaborative Submissions for our eCTD submissions because we wanted a tightly integrated solution to our...

Take Solutions Enhances PharmaReady eSubmissions Document Templates

Wireless News;  February 5, 2008 ;     340 words ......aggressively low price. In the end, Templates are as important to eCTD publishing as racing tires on a Formula 1 race car. Templates is where...functionality for creating submission-ready documents for CTD and eCTD submissions. When integrated with PharmaReady Templates, DocTemplate...

GlobalSubmit and FDA Partner on eCTD Review.

PR Newswire;  August 1, 2005 ;     352 words ......the review of the Electronic Common Technical Document (eCTD) submissions. During this collaboration, FDA has deployed the GlobalSubmit...reviewers are well positioned to handle the high volume of eCTD submissions expected in the upcoming years. Electronic submissions...

New FDA Guidance

Pharmaceutical Technology;  December 1, 2005 ;   Bush, Laura;   171 words ......Administration (Rockville,MD,www. fda.gov) released a new guidance covering the content of electronic common technical document (eCTD) submissions. The new Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Human Pharmaceutical Product Applications...

HCL TECHNOLOGIES LAUNCHES ECOMPLIANCE FOR PHARMACEUTICAL FIRMS

The Hindustan Times;  September 20, 2006 ;     351 words ......global regulatory compliance. The suite features the Company's eCTD Compliance Manager for creating, publishing and managing eCTD submissions as per the specifications laid out by International Conference on Harmonization (ICH), as well as asy Labeling, a global...

PRA International Expands Electronic Publishing Capability to Support...

U.S. Newswire;  June 18, 2007 ;     743 words ......technology are keys to success in today's market." PRA's solution is based on Liquent's InSight Publisher 3.5, which enables eCTD submissions but also supports paper submissions in countries where still required. InSight Publisher is integrated with Image Solutions...

InfoStrength Debuts Pre-configured On-Demand Service at the BIO...

Health & Beauty Close-Up;  June 20, 2008 ;     294 words ......President and CEO. Our expertise is ideally suited to answer the industry's need for help in transitioning from paper to eCTD submissions at BIO and addressing validation strategies for on-demand software solutions at DIA. InfoStrength's appearance at BIO 2008...

PRA International Expands Electronic Publishing Capability to Support...

PR Newswire;  June 18, 2007 ;     736 words ......technology are keys to success in today's market. PRA's solution is based on Liquent's InSight Publisher 3.5, which enables eCTD submissions but also supports paper submissions in countries where still required. InSight Publisher is integrated with Image Solutions...

Open Text to Showcase Leading Life Sciences Solutions at the Drug...

PR Newswire;  June 11, 2007 ;     787 words ......enabling companies to prepare and make submissions in the industry's eCTD (Electronic Common Technical Document) format. eCTD submissions can contain thousands of documents which have to be carefully managed through their respective lifecycles. Each submission...

How to Meet Regulatory Challenges in the New Year

Pharmaceutical Technology;  January 1, 2008 ;   Santos-Serrão, Patricia;   787 words ......distraction, increased costs, and diminished prospects for success. The more practical-and longterm-solution is to implement an eCTD publishing system in-house. Companies pursuing this option should seek to gain more man just eCTD compatible output Getting an eCTD...

The electronic common technical document: transition to a new paradigm in...

Pharmaceutical Processing;  January 1, 2003 ;   Cook, Jim;   787 words ......4 in September 2002. This will be followed by regional implementation--Step 5. In the meantime, eCTD testing and pilot eCTD submissions continue. The experiences gained from these evaluations will be fed into the ongoing ICH eCTD discussions. Challenges to...