Topic

Articles

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.

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

Tips for reducing site queries and improving workflows.

Better Cardiac Safety Trials

As many countries slowly progress with the “New Normal,” researchers and healthcare providers are assessing digital/virtual approaches that could reinstate clinical trials.

Fast Track Implementation of eConsent: COVID-19 Paves the Way for Virtual Trials

Biometric functional services, more than any other, can have a significant impact through the standardization of data collection and management.  

How Does FSP Models Complement eSource Implementation?

Examining how to optimizing the time and effort of Ethics Committees to efficiently and effectively fulfill their human subjects protection remit. 

Demystifying Submissions of eCOA Documentation for Ethics Review: Are We Making Submissions More Difficult than Necessary?

While there's been hopeful news on treatments and vaccines, sponsors should plan to discuss necessary strategies and contingencies at the outset of new studies or re-opening of halted studies during the COVID-19 pandemic.

How Digital Technology and Remote Assessment Strategies Can Aid Clinical Trial Research

IACT Health executive talks to Applied Clinical Trials about the importance of increased professional and technology investment at clinical trial sites.

The Ultimate Win-Win: Sites Invest, Sponsors Reward

With cloud-based software dominating data systems, on-premise installations still exist and command the pharmacovigilance software market.

PV Software is Having Its ‘Salesforce’ Moment

Debunking the six most common myths regarding electronic informed consent.

MythBusting: 6 eConsent Myths we Need to Correct in 2018

At ExL’s CROWN Congress, Cassandra Smith, Associate Director, Investigator & Patient Engagement at Janssen, discussed results from a study they conducted with patients on consent content modification.

New Janssen Study Reveals Consent Insights

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

Peter O'Donnell discusses Estonia taking over the rotating presidency of the Council of the European Union.

Turning a Digital Page in European Health?

Colton Castle is a Certified Clinical Research Coordinator in Fort Worth, TX.

As clinical trials have become more complex and costly, traditional paper-based data management systems have increasingly proved impractical and ineffective. Cloud-based technologies fit the bill, and industry professionals have begun to recognize this reality and reap the benefits at an ever-increasing rate.

The Missing Puzzle Piece of the Cloud Platform Revolution

Dr. Lauren Becnel is VP Strategy and Innovation for Clinical Data Interchange Standards Consortium (CDISC).

CDISC executive talks about the creation of their cloud-based platform to free standards from PDF documents.


SHARE-ing CDISC Standards Through a Cloud-based Metadata Repository

The challenges of data quality are a constant factor in clinical trials, especially that of traditional paper source documenting. Joyce Smith of The Medical Research Network speaks about the study’s site perspective on trial data quality.

Study Sites Indicate eSource Improves Data Quality

The adoption of electronic health records by hospitals and providers has increased engagement in Health Information Technology (HealthIT) activities. Nora Belcher of the Texas eHealth Alliance speaks on how HealthIT will change the pharma landscape for drug development.

How HealthIT Can Change the Clinical Trial Landscape

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.

Reducing the Data Burden for Clinical Investigators

A recent eConsent survey reinforces the notion that this tech innovation is the next clinical trial solution the industry will adopt.

Surveying the State of eConsent: Are There Still Barriers to be Broken Down?

Adopting eConsent provides patients with adequate information on studies they may choose to participate in, and thus improving the rate of patient satisfaction and retention.

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