Authors



Vincent J. Girardi III

Latest:

Enrollment: More Than Numbers

Partnering with CROs and using a blinded independent central review can increase trial success.


Rauha Tulkki-Wilke

Latest:

Leaping the Last Hurdle

Positive patient experiences can help drive late phase study success.


Kevin Krudys

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


Wancai Yang

Latest:

Bridging US and China to Conquer Cancer

During the annual ASCO meeting in June, the US Chinese Anti-Cancer Association (USCACA) held its fourth annual meeting to discuss the emerging role of China in global clinical development of novel anti-cancer drugs.


Luis F. Perez-Martini, MD

Latest:

Emerging Opportunity in Guatemala

Guatemala is multi-ethnic, multilingual, and multi-cultural-ideal for international trials.


Justin C. Earp

Latest:

PK in Late Phase Trials

Collecting PK data in late phase trials led to alleviating additional trials, drug approval, and better dosing.


Rob Nichols

Latest:

My 3 Key Reflections on Partnerships in Clinical Trials USA 2016

Technology advancement has been breaking down traditional barriers and has provided an answer to how the industry can move forward. The Partnerships in Clinical Trials Conference in Boston drove home this approach with three key themes that were present at the event.


Cathy Tyner

Latest:

Electronic Endpoint Adjudication

How an integrated, EDC-based system can optimize the endpoint process.




Dan Wheeler

Latest:

Rethinking Document Sharing

The benefits of peer-to-peer networking over email, fax, FTP, and hosted solutions.


Ted Acosta

Latest:

Beware of Costly Consequences

Noncompliance with the US Foreign Corrupt Practices Act carries heavy penalties.



Rebecca Hastings

Latest:

Reducing Risk Through Mitigation Strategies

Proactive risk management helps pharma protect their product development investments and future.


Holger Liebig

Latest:

Reducing Risk Through Mitigation Strategies

Proactive risk management helps pharma protect their product development investments and future.


Nicky Dodsworth

Latest:

Oh No Not Again...

Investigator training should not be a "one-off" session at the start of clinical trial.




Scott Cooley

Latest:

Triggered Monitoring

Among the many clinical development processes that need to be conducted in a smarter, more cost-effective manner, clinical data monitoring stands out as a promising area in which operational efficiencies can not only reduce costs but also improve research quality and patient safety.


Fran Turisco

Latest:

Information as a Strategic Asset

Uses for next generation information management, called health intelligence, in research.



Kai Langel

Latest:

Digital Measures of Health: What’s in it for Patients?

Exploring the different stages in the development of a digital measure, and the activities and steps key to achieving meaningful impact for patients.


Dan Foltz

Latest:

Information as a Strategic Asset

Uses for next generation information management, called health intelligence, in research.


William Looney

Latest:

Information in Action: DIA's Barbara Lopez Kunz

William Looney speaks with DIA's Global Chief Executive to see how the organization is repositioning itself.


Eileen Erdos

Latest:

Beware of Costly Consequences

Noncompliance with the US Foreign Corrupt Practices Act carries heavy penalties.


Ofelia Rodriguez Nievas, MD

Latest:

Trials in Latin America

An overview of the clinical research landscape in this emerging region that also looks at its challenges.


Henry Levy

Latest:

Reducing the Data Burden for Clinical Investigators

Clinical trials have changed significantly in the past decade with increasingly large and complex global studies. Multi-center, multinational trials are common, with complicated treatment protocols, large staffs, and huge data sets muddling the clinical trial processes. With years of development time and millions in R&D invested in a new treatment before it reaches the trial stage, there is incredible pressure on investigators to deliver quality data.


Sheila Rocchio

Latest:

Enabling Digital Transformation: Managing External Clinical Data Sources to Advance Drug Development

With an increasing amount of diverse data that must now be collected and analyzed, the industry is faced with increasingly complex studies that present new challenges in data management.


Roy Devine

Latest:

Sunshine Act's Impact

The amendment addresses data concerns for both physicians and drug/device manufacturers.

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