May 26, 2019ectd

10-Point Checklist

Regulatory SaaS From Mission3

December 09, 2008

Are traditional software companies dinosaurs? How many of the top 100 firms on this list will be thriving in 2019? Their most dangerous rivals have moved online, using the web, following the path blazed by The buzzword is software as a service (SaaS). Adobe, to take one example, said last week it is laying off 600 employees, or an eighth of its staff. Its crash-prone programs for graphic designers are losing popularity to easy SaaS photo-editing tools like Picnik and Splashup. Intuit, too, is struggling, with flat product revenues in the recent quarter—and web-only personal finance tools like Mint on the horizon. Regulatory Portal And in pharma? Where millions of pieces of paper and Microsoft Word documents are the hallowed intellectual property upon which every company depends? The industry’s reliance on Documentum is an anachronism, an embarrassment in the age of Twitter and iPhones. Is anyone in this industry doing…more...

Silo vs. Life Cycle

Octagon’s End-To-End Vision

November 10, 2008


Sponsors in denial?

2008 eCTD Train Wreck?

January 08, 2008

It’s been coming for a long time. Now it’s here. The FDA and the pharmaceutical industry adopt new processes imperceptibly. Deliberately. But as the new year begins, 2008 has at least…more...

Thursday News

$100M CRO Investment Spree

December 13, 2007

Jim Walker, chairman and CEO of clinical and regulatory systems firm Octagon Research Solutions, announced that it has completed the conversion of electronic clinical study data to CDISC’s Study Data Tabulation…more...

Friday News Briefs

DataTrak Revenues Fall

November 09, 2007

I-many, a leading provider of contract management software, has introduced version 5.2 of its I-many Contract Management Suite for Life Sciences. I-many is an advanced business intelligence reporting tool. David Blumberg, executive vice president of fulfillment services for I-many, said: “Factors related to regulatory changes, competition, customer demand, and compliance create the need for more data visibility.…more...

Friday news briefs

Kendle Earnings Fall

November 02, 2007

Top contract research organization Kendle reported a strong quarter but told Wall Street future profits would be lower than expected. Quarterly revenues jumped 33 percent to $100 million. The company lined up $175 million in new business. But net income slipped five percent to $3.8 million. Costs for the merger with Charles River were one issue during…more...

Friday News Briefs

Big Wyeth Verdict

October 12, 2007

In Nevada, a jury ordered Wyeth to pay $135 million to three women who took Premarin and Prempro. The jury said Wyeth acted with malice or fraud. Wyeth has no reserve fund for its hormone replacement therapy (HRT) cases, possibly because it has spent tens of billions of dollars to settle fen-phen litigation. The jury apparently was…more...

CDISC, PointCross, Chiltern

Wednesday News Briefs

October 10, 2007

According to Gary Buehler, director of the FDA’s Office of Generic Drugs (OGD), pharmaceutical companies should be developing the capabilities to submit common technical document (CTD) applications electronically, or should utilize eCTD applications. Although submitting both new drug applications (NDAs) and abbreviated NDAs in CTD format is recommended by the agency, the FDA will start requiring manufacturers…more...

‘Enough--This Is The Label’

RAPS: CDER’s Kweder, Part II

Reading between the lines of a presentation by Sandra Kweder of FDA-CDER. How industry may have to adapt to an evolving review process at the agency.

eCTD Readiness

Forward-Looking Regulatory Solutions

There is growing interest in software to generate the electronic common technical document (eCTD).

Diary Meeting, Criterium, FCG

Monday News Briefs

Bulletins for July 23.

Cambridge Silo Killers

Rethinking Data Warehouses at Waban

Can your clinical data warehouse combine genotyping data, clinical data and demographic data? And analyze it in a reproducible way? A conversation with Waban.

Clinical Content Management

FCG Partners with Microsoft

Since most people in the industry use Office to create clinical trial documents, Microsoft and FCG say it’s high time there is a secure environment for managing it in a regulated industry. The appeal of MOSS.

Bio-Optronics, Trialstat, Woodcock in NYT

News Briefs

News for June 4th.

Regulatory Systems

Mission3 Manages eCTDs, Projects

The rapidly growing company combines document and project management. “We’re looking at binding those two systems together in an open, web services, modern architecture way,”  says founder Dirk Karsten Beth.

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