July 25, 2014Regulatory

thumbnail
Informaticists Amuck

Why JNJ Frets About ‘Big Data’

May 04, 2012

"Big data" is both empty marketing language and a genuine business problem. IT firms are salivating to handle more data, with Google, EMC, Tibco and IBM positioning old tools for a new age. The goal is to handle high-volume, heterogenous, unstructured data in quantities too monstrous in size to fit in a standard database. Forget about mega and giga. We’re going to get to know Greek prefixes like peta and exa. Big data was a theme at this week’s 2012 Post-Approval Summit. For eight years, the meeting has been organized by academic surgeon Richard Gliklich and hosted on his turf, the Longwood portion of Harvard’s medical empire. In The Ivy Gliklich’s sizable side venture—the late-phase registry builder and contract research organization (CRO) Outcome—was sold to Quintiles last year. That has put the top CRO in the position of presiding over an elite conference at a medical school with a fabled reputation…more...

thumbnail
Intralinks Survey

With Paper, Site Pain

June 15, 2011

In a new survey of 598 investigator site personnel, there is an unhappy snapshot of the most oppressed and disgruntled segment of the clinical trial workforce. According to the survey, clinical…more...

thumbnail
DIA Web Seminar

FDA Pushes For E-source

March 03, 2011

Late last year, the FDA released a draft guidance on electronic source, or "e-source." It's not as exciting as rebelling Libyans or Charlie Sheen's rants, to be sure. But the ramifications…more...

thumbnail
Clinical Lockbox

Faster Trial Documents

November 24, 2010

IntraLinks is a document management firm with a focus on financial services and life sciences—regulated industries that move around electronic and cellulose-based forms. The New York City company is betting that…more...

thumbnail
Profile: Target Health

Ending Mindless Monitoring

October 04, 2010

Some contract research organizations (CRO) had to be dragged into using technology. They presented at conferences, pooh-poohing software. They doubted, delayed, complained. They did not necessarily advocate fountain pens and carrier pigeons. But they could quote a price on ink and birdseed. And then there are people like Jules Mitchel, president of Target Health. He delights in…more...

thumbnail
Lax Trial Oversight

HHS Assesses FDA Overseas

July 07, 2010

Are international clinical trials regulated? By the FDA? By anyone? In gentle language, the U.S. Department of Human Services says that one of its own fiefdoms, the FDA, has been unable to keep up with the rapid growth in clinical research outside America. The push to find clinical trial patients outside the U.S. is not news. But…more...

thumbnail
Converging Data Challenges

How To Help FDA

June 10, 2010

Not long ago, the Drug Information Association (DIA) and FDA’s two most important divisions, CDER and CBER, held a joint meeting. Its title was less than intuitive: “Computational Science Annual Meeting.” But the goal of the meeting was laudable and significant to everyone in clinical research. The idea was to explore how technology, broadly defined, could help…more...

thumbnail
Getting Registries In Sync

Content Management From Virtify

January 27, 2010

What do life science companies produce? Medicine? Pacemakers? In truth, those items are often manufactured by anonymous subcontractors. What life science companies really do generate is intellectual property. Data. Content. Satish Tadikonda, the founder, president and CEO of Virtify, says that the content in our regulated industry will increasingly be required to adhere to a variety of…more...

Our How-To

Special Protocol Assessments

To double-check that Phase III protocols are viable before a study starts, sponsors can approach the FDA for a quick sign off.

FDA, EMEA Collaborate

Bilateral GCP Inspections

Starting in a few weeks, FDA and EMEA will work together on GCP inspection issues. Their call to the sponsor community.

CRO Inspections

New Regs in India

With Schedule Y-1, outsourcing firms (and executives) in India have new forms to fill out.

A Quick History

India’s Regulation Timeline

From 1940 to the present, India’s regulations have evolved and affected its clinical research landscape.

On Clinical Consistency

CDISC For Skeptics

Kit Howard of Kestrel Consultants discusses how to implement data standards throughout an organization.

Clinical Cloud

SAS Does SAAS

SAS adapts a large, complex repository for web-based usage by small- and mid-sized sponsors.

The Great Sync

Trial-Friendly EHR Systems

It’s auspicious. Suppliers of clinical trial systems and physician systems are integrating their software. An exclusive chat with Landen Bain.


© 2014 ClinPage. All Rights Reserved.