Clinical Trials in Slovakia
The history of clinical trials in Slovakia goes back to the mid- 1990s and the quality has been improving since…
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Selection of Challenge Agent is Key to Vaccine Development
Influenza viruses are commonly used in human challenge studies. Both the viruses and the disease they cause are well understood,…
Maximising Value in the Rare Disease Sector: Begin with the End in Mind
Interest in the development of medicines to alleviate or cure rare diseases has increased due to positive actions taken by…
FDA Clarifies Clinical Pharmacology Studies to Support Biosimilarity
As defined by section 351(k) of the Public Health Service (PHS) Act, a biosimilar product is highly similar to its…
Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics
Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development…
How Integration of Consumer and Medical Devices is Reshaping Clinical Trials
The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new…
Why would Cardiovascular Outcomes Trials and Rare Disease Studies have Anything in Common?
Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up…
Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management
Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM)…
Why and How a Research Lab Should Embrace Research Quality
The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the…
Latest FDA Guidance on Non-Inferiority Designs
To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence”…