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International Clinical Trials

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Spring 2020

   
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Features
Comparator Sourcing in Clinical Studies (Part Two of Two)

In the conclusion of this two-part article, the evolving pharma market is addressed, along with how certain phenomena in the commercial sector have shaped the drugsourcing methodologies utilised in the research sector today

Toby Watkins at CTSS
 
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UK Data Protection in Post-Marketing Pharmacovigilance

New guidance notes prepared by PIPA intend to help companies performing post-marketing pharmacovilance in the UK meet their data protection obligations

Avile Grey at PIPA
 
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Search and Rescue

ICT speaks to Leslie Jones at WuXi Clinical about the reasons behind why some clinical trials need rescuing, how to select the right rescue CRO, and how to ensure a successful transition
 
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eClinical Technologies
The Long Road to eSource

Since the introduction of electronic diaries in the early 2000s, eSource has provided an excellent opportunity to not only streamline clinical research, but increase data quality and trustworthiness

Rebecca D Kush at Elligo Health Research
 
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Managing Trial Data Collection for Success

From EDC to DDC, BYOD, and beyond, clinical trial data collection is an evolving field that must now step up to make virtual trials and the future of clinical data management a reality

Ed Seguine at Clinical Ink
 
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Patient Recruitment
Turning Over the Right Stones: Rethinking the Recruitment Process

Patient enrolment is often approached broadly with paid media campaigns and social outreach, but should a more streamlined method be adopted to ensure a successful recruitment process?

Tyler Bye at WCG ThreeWire
 
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Targeted Online Marketing in Patient Recruitment

In a world brimming with connectivity, patient recruitment efforts can be optimised by a targeted online marketing approach, utilising technology-based platforms

Bethany Bray at AutoCruitment
 
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Study-Life Balance: Re-envisioning the Patient Experience

A new clinical trial construct leverages patient-centric solutions in response to today’s empowered healthcare consumer, who has expectations for an enhanced healthcare experience

Jessica Kim at BBK Worldwide
 
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A Digital Approach to Enrolment

ICT met with Barbara D’haene and Nathalie Niclaus at Akcelis (recently acquired by Pivotal) to talk on the current make-up of patient enrolment and how digital technologies can be used to better target patient populations
 
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COVID-19
Is the Pandemic a Time for Inflection or Reflection?

While many clinical trials are paused for the pandemic, can we find ways to reframe the clinical research landscape for a brighter healthcare future?

Sarah Beeby at Clinithink
 
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While the World Waits

In response to the urgent need for a vaccine and treatments for COVID-19, researchers are, at the time of writing, running approximately 500 clinical trials, and counting, on a number of antivirals and vaccines

Cindy Dukes at ICON
 
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From Zero to Sixty: Why Yesterday’s eClinical Trial Horizon Is Today’s Reality

Signant Health discusses the possibilities for trials post-pandemic. After a digital revolution in the way we conduct research, why would we want to go back?

Bill Byrom and Barb Enger at Signant Health
 
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Pushing ‘Go’ Again on Clinical Trials in a Post-COVID-19 World

COVID-19 has caused a revolution in the world of clinical research, with the industry turning to home health, direct-to-patient, and telemedicine. What of those already planning for patients returning to site?

Andy Thurstan at Illingworth Research Group
 
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Accelerating COVID-19 and Other Vaccine Trials Without Sacrificing Data Quality

How can a reusable eDiary platform benefit sponsors, sites, and study participants with the challenges involved in vaccine clinical trials?

Matt McCarty and Nadeeka Dias at ERT
 
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Cardiac Safety
Navigating ECG Cardiac Safety Requirements

To prevent the risk of induced arrhythmias in cardiac drug development, it is important for developers and biotech companies to adhere to ECG safety requirements in early stage research

Jay W Mason and Cassandra Erato at Spaulding Clinical Research
 
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Integration of Cardiac Endpoints

Within R&D and drug development, there is growing insight and direction related to the integration of ECG and blood pressure, as well as cardiac imaging endpoints in oncology clinic trials

Jeff Heilbraun at Bioclinica
 
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Transformational Real-World Applications

Momentum and vision around identification of medicinal products must be maintained in 2020 so approved, standardised medicines data become the de facto means of wide scale information exchange and delivery

Remco Munnik at Iperion
 
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The Future Awaits Us

On the back of the release of Trilogy Writing & Consulting’s second special edition magazine, EPC sits down with Barry Drees to expand on medical writing trends in the industry
 
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Role of Comparators in Clinical Trial Designs

It is important to analyse the role of comparators in different trial designs, but which methodology should be applied for choosing the most appropriate comparators?

Dr Vanessa Dekou at Clinical Services International
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Stability Testing and Forced Degradation Stress Tests - Proactive Risk Management

Whereas the durability of many consumables, have a strong tendency to decrease, stability is and remains a crucial factor for pharmaceuticals. That is why the identification and elimination of factors, which put long-term stability at risk, is central during development – and an important requirement concerning the product’s quality.
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White Papers

Time lapse photography to demonstrate the potential antimicrobial abilities of Dycem contamination control flooring

Dycem

A defined volume of bioluminescent reporter bacteria was deposited onto 20 mm x 20 mm coupons of Dycem flooring, vinyl tile and ITW Alma tacky mat. Through monitoring of bacterial bioluminescence, metabolic inhibition was observed on all three surfaces however the effect occurred more rapidly on Dycem flooring than on vinyl or ITW Alma. Recovery counts after three hours of exposure to the floor surfaces showed between a 65% and 100% decrease in the number of viable organisms recovered from Dycem flooring compared to controls. On vinyl and ITW Alma flooring, there were slight increases in the number of viable survivors recovered compared to controls. Dycem flooring inhibited the metabolic activity and reduced the number of viable survivors recovered of Salmonella enterica Serovar Typhimurium DT104 pGLITE. It remains unclear as to whether this effect is attributable to the impregnated biocide or rapid drying of the inoculum on this surface.
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Industry Events

Evolution Summit

20-22 July 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
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