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JCS Volume 15 Issue 3
 
FDA Attempting to Address Unmet Needs for Patients with Brain Metastases
Volume 11 Issue 3

FDA Attempting to Address Unmet Needs for Patients with Brain Metastases

Molly Fellin Spence of Clarivate discusses the FDA’s efforts towards advancing the development of products for CNS metastases, where effective treatments and clinica...
17 June 2019 Volume 11 Issue 3
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Academic Collaboration with Contract Research Organisations: Reaching Out to the Right Expertise at the Right Time
Volume 11 Issue 3

Academic Collaboration with Contract Research Organisations: Reaching Out to the Right Expertise at the Right Time

Drug discovery and development, while usually a role of the pharmaceutical industry, is a long, difficult and expensive process, which can present academic organisat...
17 June 2019 Volume 11 Issue 3
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Providing Regulatory Clarity for Cell- and Gene-based Therapies
Volume 11 Issue 3

Providing Regulatory Clarity for Cell- and Gene-based Therapies

Adam Istas, DIA explores how global regulators are responding to dramatic increases in cell and gene-based products in development. Regulators are working to provide...
17 June 2019 Volume 11 Issue 3
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What Can LOINC Do for SDTM?
Volume 11 Issue 3

What Can LOINC Do for SDTM?

LOINC is an internationally recognized classification system and is often requested in regulatory data submissions to provide context to clinical measurement data su...
17 June 2019 Volume 11 Issue 3
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Modelling and Simulation is Key to Modern Drug Development
Volume 11 Issue 3

Modelling and Simulation is Key to Modern Drug Development

The FDA has been promoting innovative and disruptive approaches towards modernizing drug development and clinical trials, which the industry has been slow to adopt. ...
17 June 2019 Volume 11 Issue 3
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Clinical Evaluation & Post-marketing Surveillance of Medical Devices in Singapore
Volume 11 Issue 3

Clinical Evaluation & Post-marketing Surveillance of Medical Devices in Singapore

Dr Balamuralidhara V. et al of the JSS College of Pharmacy present a study which examines the clinical evaluation and post-marketing surveillance requirements of med...
17 June 2019 Volume 11 Issue 3
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How Engaging Patients in Trial Design Maximises Orphan Drug Success
Volume 11 Issue 3

How Engaging Patients in Trial Design Maximises Orphan Drug Success

Orphan drug discovery presents both opportunities and challenges, with research in this space having some of the highest hurdles in medicine. Clinical trial design a...
17 June 2019 Volume 11 Issue 3
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Drug Delivery to the Eye: The Challenges and Opportunities of Drug Delivery Through a Complex Barrier
Volume 11 Issue 3

Drug Delivery to the Eye: The Challenges and Opportunities of Drug Delivery Through a Complex Barrier

Eye health and vision has a major impact on the quality of life, and as such the development of products within this area is a lucrative market. Therapeutic research...
17 June 2019 Volume 11 Issue 3
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Clinical Research in Rare Diseases: Adult Onset Still’s Disease
Volume 11 Issue 3

Clinical Research in Rare Diseases: Adult Onset Still’s Disease

Adult onset Still’s disease (AOSD) is a rare inflammatory joint disease of unknown aetiology, characterised by arthritis, fevers spiking once or twice a day, salmon-...
17 June 2019 Volume 11 Issue 3
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Volume 11 Issue 3

The Case for Response Adaptive Trial Design for Rare Diseases

With 7,000 rare diseases affecting 350 million people worldwide, Holly Jackson at Quanticate identifies how businesses exploring rare diseases can continue their suc...
17 June 2019 Volume 11 Issue 3
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