eClinical

eClinical, eSource and EHRs is the journey to the holy grail of data efficiency in clinical trials.

Shiri Diskin, PhD, Head of Medical Writing at Bioforum, sits down with Daphna Laifenfeld, PhD, Chief Scientific Officer at Ibex Medical Analytics to discuss the challenges associated with developing a CER and how to effectively navigate them while creating opportunities that increase efficiencies.

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.

Tips for reducing site queries and improving workflows.

Tips for reducing site queries and improving workflows.

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

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

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

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.

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

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

Debunking the six most common myths regarding electronic informed consent.

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.

Debunking the six most common myths regarding electronic informed consent.

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

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.

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

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.

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.

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.

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

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.

With the term "innovation" a buzzword du jour these days, the important quest for industry is to reimagine R&D using its new capabilities to apply real-world evidence, patient engagement, and collaborative technologies.

A technology-driven approach to oversight of vendors and sites can provide sponsors with timely and proactive solutions toward minimizing risks.

Roger DeRaad of Black Hills Cardiovascular Research and his staff discuss their experiences using IRT systems with 4G Clinical’s Kathleen Greenough. They offer insights into how sites, sponsors and technology vendors can cooperate to bring simplicity to clinical trials.

Electronic clinical outcome assessment (eCOA) devices have shown to be effective at avoiding missing data with a failure percentage at less than one percent. Paper back-up provisions produce a lesser value of clinical trials data captured and should be considered outdated.

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 3 covers how sponsors can humanize eCOA to help increase patient engagement during clinical trials.

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 2 covers how sponsors can improve upon their user interface of electronic diaries.

This 3-part series presents results from a study of patient preferences regarding electronic Clinical Outcome Assessments in clinical trials. Part 1 covers how sponsors can improve the study design and logistics of electronic diaries.

Technology platforms are today continually being adapted into the clinical trial life cycle with the promise of efficiency and reduced risk. CRF Health believes its combined eCOA/eConsent solution could improve the flow of documentation between investigators and sponsors.