International Clinical Trials |
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Editor's Comment
ICT Editor Graham Hughes introduces the issue by highlighting this quarter’s main themes, including eClinical advances, pharmacovigilance and patient engagement.
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FDA Investigations
Safety Warning
Due to the increasing importance of pharmacovigilance in drug development, the FDA has begun to conduct more rigorous inspections – leading to some companies receiving a warning letter. Sciformix Corporation’s Dr Mitchell Gandelman discusses how best to avoid these.
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Pharmacovigilance Update
New FDA Guidance: Impact on Clinical Safety Data
Suspected adverse events have come under growing scrutiny by the FDA, observe NDA Group’s Dr Brian Edwards and Olga Björklund, and emphasise that staying fully up-todate with regulations is the only way to remain compliant.
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Clinical Trial Efficiency
How-To Guide
Craig Morgan at goBalto laments the fact that SOPs are still not utilised to their full potential in clinical trial start-ups, despite their positive impact on budgets, timelines and clinical trial efficiency in general.
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Risk-Based Monitoring
Embrace Change
Small- and medium-sized enterprises have not yet adopted a risk-based monitoring model despite its cost- and quality-associated benefits, observe Abby Abraham at Algorics and Eric Jacobson at MedNet Solutions. What can be done to encourage implementation?
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eClinical Advances
Capture the Data
In light of the rapid transition from paper-based to electronic workflows, Marc Desgrousilliers and Eric Morrie at ClinCapture give an overview of the current eClinical technology available to the pharmaceutical industry.
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Digital Trials
Transformed Reality
Appian’s Evjatar Cohen examines how quality in electronic clinical trials can be maintained – and both mobility and collaboration seem to be key aspects in driving a digital transformation forward.
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Biosimilar Development
Growth Spurt
The increasing demand in biosimilars – cheaper versions of authorised drugs – is leading emerging countries to start looking into heavier investment. Rajveer Singh Rathor at MarketsandMarkets reports.
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End Point
Brexit Implications
Now that the UK has voted to leave the EU, Graham Hughes comments on potential outcomes of Brexit for the pharma industry.
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Feasiblity Assessment
Why Risk It?
Poor risk management is a real cause of concern for pharma, says Centrical Global’s Dr Guy Patrick. Having proven risk management plans in place may help to avoid negative outcomes in patients, products and studies.
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Cold Chain Management
Under Control
Pelican BioThermal’s Kevin Lawler looks at what temperature-controlled packaging manufacturers are doing in terms of mitigating cold chain risks to address the demands of an evolving clinical landscape.
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Patient Motivation
Soothing Recruitment and Retention Headaches the Logistical Way
Keeping subjects motivated during a study is anything but simple. EQ Travel’s Franc Jeffrey explores some of the reasons why and proposes the involvement of a travel management company as a solution.
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Electronic Patient Recruitment
Pick and Choose
The process of enrolling suitable patients in a study is, at best, cost- and time-intensive, leading to heightened risk in the development of drugs. Tigran Arzumanov, Bernhard Bodenmann and Le Vin Chin at Clinerion investigate whether recent advances in data analytics could facilitate his search.
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Patient Engagement Technologies
Customer Loyalty
Recent technological advances in patient retention have failed to take into account two other major stakeholders, states Dr Chris Watson at Exco InTouch, who further explains what sponsors and CROs stand to gain from implementation of these developments.
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Q&A: Cloud-Based Solutions
Stronger Through Collaboration
Anne Zielinski at Bioclinica eHealth Solutions talks to ICT about their recent partnership with ARISGlobal, designed to pool resources and strengthen both businesses’ portfolios.
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Company Q&A
Logistical Challenges of Tomorrow
ICT questions Volker Kirchner at World Courier about the company’s dedication to serving the temperaturecontrolled needs of the pharma industry, and the reasons behind their success.
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Q&A: Electronic Data Acquisition
Tipping Point
Dr Michael Murphy at Worldwide Clinical Trials investigates the use of technology in trials, and the effect this has on clinical operations as a whole.
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